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- Mometasone furoate for allergic rhinitis
Mometasone furoate is a synthetic corticosteroid which has been evaluated for intranasal use in the treatment of adults and children with allergic rhinitis.
In several large, well-controlled clinical trials, mometasone furoate micrograms administered once daily as an aqueous intranasal spray was significantly more effective than placebo in controlling the symptoms associated with moderate to severe seasonal or perennial allergic rhinitis.
Mometasone furoate was as effective as twice-daily beclomethasone dipropionate or once-daily fluticasone propionate in the treatment of perennial allergic rhinitis, and was as effective as twice-daily beclomethasone dipropionate and slightly more effective than once-daily oral loratadine in the treatment of seasonal allergic rhinitis.
Mometasone furoate was also as effective as twice-daily beclomethasone dipropionate or once-daily budesonide, and significantly more effective than placebo in the prophylaxis of seasonal allergic rhinitis. The onset of action of mometasone furoate was approximately 7 hours in patients with seasonal allergic rhinitis. Mometasone furoate was as well tolerated as beclomethasone dipropionate, fluticasone propionate and budesonide in clinical trials, with an overall incidence of adverse events similar to placebo.
Adverse events were generally mild to moderate and of limited duration. It is effective in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis in patients with moderate to severe symptoms. Abstract Mometasone furoate is a synthetic corticosteroid which has been evaluated for intranasal use in the treatment of adults and children with allergic rhinitis.
Publication types Review.
❿Mometasone furoate for allergic rhinitis
Multidisciplinary Respiratory Medicine volume 11Article number: 18 Cite this article. Metrics details. Intranasal administration of corticosteroids, being fast, simple, and not requiring cooperation, is the preferred way to treat the patients, to optimize their quality of life, at the same time minimizing the risk of exacerbations and complications.
Among the different topical steroids available on the market, we performed a comparative analysis in terms of effectiveness and safety between mometasone furoate MF and its main competitors. Taking into account relevance and date of publication, a sample of 40 articles was considered for the review. Even though it has not been assessed for MF in particular, topical steroids are the most appropriate treatment in mixed rhinitis and NARES.
In acute rhinosinusitis ARS evidences support their use as mono-therapy or as adjuvant to antibiotics for reducing the recurrence rate, and decrease the usage of related prescriptions and medical consultations. In chronic rhinosinusitis CRS with Nasal polyposis, MF reduces polyps size, nasal congestion, improves quality of life and sense of smell and it is also effective in the treatment of daytime cough. The topical use of MF has great efficacy in the management of adenoidal hypertrophy and otitis media of atopic children.
As regards the safety, MF has demonstrated an excellent safety profile: pregnant women can safely use it; no systemic effects on growth velocity and adrenal suppression have been shown; no changes in epithelial thickness or atrophy have been observed after long term administration of the drug. Conclusions: MF has been demonstrated to be effective in the treatment of the inflammatory diseases of the nose and paranasal sinuses; when compared to its competitors it shows a greater symptom control; it is a reliable treatment in the long term thanks not only to its proven efficacy, but also to its safety being on the market since more than 17 years.
Rhinitis is a common inflammation of the nasal membrane of the nose, caused by viruses, bacteria, and other irritants as well as allergens. Even if it is usually associated with inflammation, some forms of rhinitis, such as vasomotor or athrophic rhinitis, are not predominantly inflammatory. The persistent inflammatory condition of the nose and paranasal sinuses clinically manifests itself with many symptoms and complications, such as nasal congestion, sneezing, coughing, headaches, rhinorrhea anterior or posterioritching, malaise, pain, and fatigue.
Those afflictions are frequently accompanied by symptoms involving the eyes, ears and throat and combined together, they all severely affect the quality of life. Enlarged adenoids and infection of adenoid tissue may lead to the obstruction of the breathing patterns in children, causing apnea during sleep and contibuting to recurring sinusitis and persistent middle ear disease. Rhinitis, as well as nasal congestion, may also lead to airway obstruction and an increased number of sleep microarousals, both in children and adults.
Sleep disturbances can detrimentally affect daytime energy levels, mood, and, consequently, determine daytime fatigue [ 1 ]. Appropriate use of medical therapies is necessary to optimize patient quality of life and daily functioning and minimize the risk of acute inflammatory exacerbations and complications. The most common therapies for the aforementioned diseases are topical nasal sprays which could be natural or pharmaceutical products. Intranasal route is generally preferred by both patients and doctors: it is fast, simple, does not require cooperation, the drug assimilation is direct and quick and compliance to therapy is high.
Among these sprays, corticosteroid topical application is undoubtedly the most widely used and most effective [ 23 ] although minor side effects could be reported nose bleeding, dryness, crusting. Glucocorticosteroids are used in upper airway diseases: allergic and non allergic rhinitis, particularly non allergic rhinitis with eosinophilia syndrome NARESacute and chronic rhinosinusitis, with and without nasal polyps, adenoid hypertrophy with or without middle era disease.
There are many other possible therapies, either medical or surgical, and especially for allergic rhinitis management many different therapeutical strategies are available. Effective measures include allergen avoidance pollens, fungi, dustmite-proof covers, air filters and nasal irrigation, and the best results are obtained when combined with intranasal steroids. Other pharmacological options should be taken into account if those measures are not effective, and they include antihistamine drugs, that could be taken orally or nasally, pseudoephedrine, cromolyn, leukotriene receptor antagonists.
Thus far, evidence suggests that intranasal corticosteroids produce greater relief of nasal symptoms than topical antihistamines H1 receptor antagonistseven if no difference in ocular symptoms has been reported [ 4 ]. Long-term tolerance to allergens can be induced by immunotherapy, but the desensitiziation therapy is often considered to be quite expensive [ 5 ].
Moreover, the capacity of sublingual allergen immunotherapy SLIT to provide effective symptom relief in seasonal allergic rhinitis has also been questioned. It has been reported that SLIT tablets had a greater clinical impact than second-generation antihistamines and montelukast, but when compared to nasal corticosteroids, the beneficial effects were the same [ 6 ].
Alternative treatments such as acupuncture and homeopathy, even if quite popular, are not supported by any evidence. Intranasal corticosteroids may be useful in the treatment of some forms of non-allergic rhinitis and should be an appropriate choice for mixed rhinitis. Evidence [ 7 ] declares them to be useful for the treatment of non allergic rhinitis with eosonophilia syndrome.
Also for chronic CRS and acute ARS rhinosinusitis various topical therapies are available: saline solutions, antibiotics, corticosteroids, and antifungals.
Topical saline and corticosteroids should be considered as the first line of therapy for CRS [ 8 ] and evidence supports its use as a monotherapy or as an adjuvant therapy to antibiotics in ARS [ 9 ]. Corticosteroid nasal sprays include: beclometasone diproprionate, budesonide, ciclesonide, flunisolide, fluticasone furoate, fluticasone proprionate, triamcinolone acetonide, and mometasone furoate. With so many different sprays available in the market, many authors decided to compare efficacy, side-effect profile and relative cost of each product, to assess which - and if - one is the best [ 2 ].
Results have too often been controversial and there is no clear evidence in favour of one or the other. Thus far it has been established that all the sprays have a similar side-effect profile, and the most significant differences might be related to patient's personal preference for each product sensory attributes [ 10 — 12 ] and costs. Mometasone furoate MF is used in the treatment of rhinitis and rhinosinusitis as well as asthma [ 13 ], inflammatory skin disorders and penile phimosis.
Evidence suggests that its usage improves symptoms related to adenoid hypertrophy, too. To assess MF nasal spray effectiveness and safety we decided to analyze the scientific publications related to this molecule and to perform a comparative analysis between MF and its main intranasal competitors. The database search revealed articles.
Out of these, met eligibility criteria and were assessed independently by two authors for further evaluation. A sample of 40 articles was considered for this review, taking into account relevance and date of publication. We then proceded to evaluate mometasone furoate nasal spray efficacy, safety, and cost-effectivenes.
Inmometasone furoate was introduced as a nasal spray. MF has been largely successful since it was first sold. Evidence [ 14 — 16 ] shows that - at least for asthma maintenance - 1spray daily should be enough thus diminishing both costs and side effects. To obtain the best results, as most topical intranasal corticosteroids, it is strongly suggested to blow the nose to clear the passageway before the application or perform a nasal irrigation, and to avoid sneezing or blowing the nose right after spraying.
Intranasal corticosteroid therapy also has a beneficial effect in relieving eye symptoms in allergic conjunctivitis, similar to oral or intranasal antihistamines [ 19 — 21 ] according to reviews. Even though it has not been clearly assessed for MF in particular, its usage should improve other forms of rhinitis, like mixed forms or NARES. Compared with antibiotics monotherapy, using MF nasal spray for initial ARS treatment, alone or combined with an antibiotic, has been demonstrated to reduce the recurrence rate and decrease the usage of related prescriptions and medical consultations [ 22 ].
As regards the treatment of nasal polyposis, MF, if administered daily, reduces polyp size and the nasal congestion, improving quality of life and sense of smell, with no unusual or unexpected adverse events [ 23 — 25 ].
Furthermore, regarding other minor complaints associated with rhinitis and rhinosinusitis, mometasone furoate nasal spray has been shown to be safe, effective and well tolerated in the treatment of daytime cough, too [ 26 ]. InMinshall et al. Through nasal biopsies, they assessed that long-term administration of the drug attenuates the inflammatory process decreasing the extent of inflammatory cell infiltration especially eosinophils and did not determine changes in epithelial thickness or atrophy.
It has also been well established that the topical use of MF in the pediatric population shows great efficacy for management of adenoidal hypertophy [ 28 ] and otitis media with effusion [ 29 ], despite the concomitant presence of atopy [ 30 ]. Lastly, as reported in a recent cost-effectiveness analysis [ 31 ] when compared to beclomethasone diproprionate, the therapy with mometasone furoate for treating children suffering from allergic rhinitis showed a greater improvement, better efficacy, safety, and lower total treatment cost.
As regards the safety of the drug, the same results were obtained when administered in children for nasal polyps, even at double the recommended pediatric dosage for allergic rhinitis [ 32 ]. Pregnant women can safely use intranasal steroids.
The sprays work only in the nasal passageway and the medicine does not affect other parts of the body unless too much is used [ 3 ]. Until now, despite parents apprehension, topical application of MF - respecting the recommended dosage - has not shown systemic effects. Many studies have been conducted to investigate its effects on growth velocity and its potential to cause adrenal suppression [ 3334 ].
Thus far, no significant difference has been reported and the current guidelines for asthma recommend inhaled corticosteroids for the control of mild to severe persistent asthma in adults as well as adolescents. MF dry powder inhaler has been demonstrated to have an excellent safety and efficacy profile, and during post-marketing surveillance and in clinical trials no significant adverse side effects have been reported.
In addition, its simple use seems to improve asthma management by addressing issues that generally inhibit proper adherence to therapy [ 35 — 38 ]. These considerations for the usage of MF in asthma could be extended to MF administered via the intranasal route. Each steroid preparation comes with patient instructions for safe and effective use.
For best results, the medication should be used following this direction carefully and according to medical advice. Adherence to long-term therapy is essential to have the desired results. In fact, intermittent therapy may not guarantee the same benefits.
This is even more true in the case of a chronic disease. Moreover, non-adherence to treatment may also require that, if an acute attack occurs, a higher dose of medication would be required, and possibly even asteroid molecule orally or intramuscularly administered.
The large quantity of different preparations available could also allow the doctor - in case of molecules with the same efficacy, dosage and quality of the dispenser - to choose the most convenient for the patient, taking into account the expenses related with long term use.
Expenses are halved when analyzing children up to 11 years of agedue to the fact that the recommmended dosages are of one spray for each nostril once daily. Results were not always in favour of MF, but Meltzer et al. Last but not least, it is a fact that all steroids suppress gene expression of factors responsible for generating and supporting inflammatory processes but furoates earn special attention as their lateral furoate ester chain makes the molecules highly lipophilic.
Thus, the moleculas are easily absorbed by mucous membranes, epithelium and cell membrane phospholipids. This minimizes their general action and maximizes local action [ 39 ]. MF has been demonstrated to be safe, effective and, if compared to its competitors, it shows symptom control greater than the other products in the market.
Nasal congestion secondary to allergic rhinitis as a cause of sleep disturbance and daytime fatigue and the response to topical nasal corticosteroids. J Allergy Clin Immunol. Intranasal steroid sprays in the treatment of rhinitis: is one better than another? J Laryngol Otol. The diagnosis and management of rhinitis: an updated practice parameter.
Article PubMed Google Scholar. Intranasal corticosteroids versus topical H1 receptor antagonists for the treatment of allergic rhinitis: a systematic review with meta-analysis.
Ann Allergy Asthma Immunol. Clin Exp Allergy. A meta-analysis of sublingual allergen immunotherapy and pharmacotherapy in pollen-induced seasonal allergic rhinoconjunctivitis. BMC Med. Intranasal fluticasone propionate is effective for perennial nonallergic rhinitis with or without eosinophilia. Huang A, Govindaraj S. Topical therapy in the management of chronic rhinosinusitis. Zalmanovici Trestioreanu A, Yaphe J. Intranasal steroids for acute sinusitis. Cochrane Database Syst Rev.
PubMed Google Scholar.
❾-50%}Mometasone furoate for allergic rhinitis.Mometasone furoate. A review of its intranasal use in allergic rhinitis
Mometasone furoate is a synthetic corticosteroid which has been evaluated for intranasal use in the treatment of adults and children with allergic rhinitis. In several large, well-controlled clinical trials, mometasone furoate micrograms administered once daily as an aqueous intranasal spray was significantly more effective than placebo in controlling the symptoms associated with moderate to severe seasonal or perennial allergic rhinitis.
Mometasone furoate was as effective as twice-daily beclomethasone dipropionate or once-daily fluticasone propionate in the treatment of perennial allergic rhinitis, and was as effective as twice-daily beclomethasone dipropionate and slightly more effective than once-daily oral loratadine in the treatment of seasonal allergic rhinitis.
Mometasone furoate was also as effective as twice-daily beclomethasone dipropionate or once-daily budesonide, and significantly more effective than placebo in the prophylaxis of seasonal allergic rhinitis. The onset of action of mometasone furoate was approximately 7 hours in patients with seasonal allergic rhinitis. Even if it is usually associated with inflammation, some forms of rhinitis, such as vasomotor or athrophic rhinitis, are not predominantly inflammatory.
The persistent inflammatory condition of the nose and paranasal sinuses clinically manifests itself with many symptoms and complications, such as nasal congestion, sneezing, coughing, headaches, rhinorrhea anterior or posterior , itching, malaise, pain, and fatigue. Those afflictions are frequently accompanied by symptoms involving the eyes, ears and throat and combined together, they all severely affect the quality of life.
Enlarged adenoids and infection of adenoid tissue may lead to the obstruction of the breathing patterns in children, causing apnea during sleep and contibuting to recurring sinusitis and persistent middle ear disease. Rhinitis, as well as nasal congestion, may also lead to airway obstruction and an increased number of sleep microarousals, both in children and adults. Sleep disturbances can detrimentally affect daytime energy levels, mood, and, consequently, determine daytime fatigue [ 1 ].
Appropriate use of medical therapies is necessary to optimize patient quality of life and daily functioning and minimize the risk of acute inflammatory exacerbations and complications. The most common therapies for the aforementioned diseases are topical nasal sprays which could be natural or pharmaceutical products. Intranasal route is generally preferred by both patients and doctors: it is fast, simple, does not require cooperation, the drug assimilation is direct and quick and compliance to therapy is high.
Among these sprays, corticosteroid topical application is undoubtedly the most widely used and most effective [ 2 , 3 ] although minor side effects could be reported nose bleeding, dryness, crusting. Glucocorticosteroids are used in upper airway diseases: allergic and non allergic rhinitis, particularly non allergic rhinitis with eosinophilia syndrome NARES , acute and chronic rhinosinusitis, with and without nasal polyps, adenoid hypertrophy with or without middle era disease.
There are many other possible therapies, either medical or surgical, and especially for allergic rhinitis management many different therapeutical strategies are available.
Effective measures include allergen avoidance pollens, fungi, dust , mite-proof covers, air filters and nasal irrigation, and the best results are obtained when combined with intranasal steroids. Other pharmacological options should be taken into account if those measures are not effective, and they include antihistamine drugs, that could be taken orally or nasally, pseudoephedrine, cromolyn, leukotriene receptor antagonists.
Thus far, evidence suggests that intranasal corticosteroids produce greater relief of nasal symptoms than topical antihistamines H1 receptor antagonists , even if no difference in ocular symptoms has been reported [ 4 ].
Long-term tolerance to allergens can be induced by immunotherapy, but the desensitiziation therapy is often considered to be quite expensive [ 5 ]. Moreover, the capacity of sublingual allergen immunotherapy SLIT to provide effective symptom relief in seasonal allergic rhinitis has also been questioned. It has been reported that SLIT tablets had a greater clinical impact than second-generation antihistamines and montelukast, but when compared to nasal corticosteroids, the beneficial effects were the same [ 6 ].
Alternative treatments such as acupuncture and homeopathy, even if quite popular, are not supported by any evidence. Intranasal corticosteroids may be useful in the treatment of some forms of non-allergic rhinitis and should be an appropriate choice for mixed rhinitis. Evidence [ 7 ] declares them to be useful for the treatment of non allergic rhinitis with eosonophilia syndrome.
Also for chronic CRS and acute ARS rhinosinusitis various topical therapies are available: saline solutions, antibiotics, corticosteroids, and antifungals. Topical saline and corticosteroids should be considered as the first line of therapy for CRS [ 8 ] and evidence supports its use as a monotherapy or as an adjuvant therapy to antibiotics in ARS [ 9 ].
Corticosteroid nasal sprays include: beclometasone diproprionate, budesonide, ciclesonide, flunisolide, fluticasone furoate, fluticasone proprionate, triamcinolone acetonide, and mometasone furoate. With so many different sprays available in the market, many authors decided to compare efficacy, side-effect profile and relative cost of each product, to assess which - and if - one is the best [ 2 ]. Results have too often been controversial and there is no clear evidence in favour of one or the other.
Thus far it has been established that all the sprays have a similar side-effect profile, and the most significant differences might be related to patient's personal preference for each product sensory attributes [ 10 — 12 ] and costs. Mometasone furoate MF is used in the treatment of rhinitis and rhinosinusitis as well as asthma [ 13 ], inflammatory skin disorders and penile phimosis.
Evidence suggests that its usage improves symptoms related to adenoid hypertrophy, too. To assess MF nasal spray effectiveness and safety we decided to analyze the scientific publications related to this molecule and to perform a comparative analysis between MF and its main intranasal competitors.
The database search revealed articles. Out of these, met eligibility criteria and were assessed independently by two authors for further evaluation. A sample of 40 articles was considered for this review, taking into account relevance and date of publication.
We then proceded to evaluate mometasone furoate nasal spray efficacy, safety, and cost-effectivenes. In , mometasone furoate was introduced as a nasal spray. MF has been largely successful since it was first sold. Evidence [ 14 — 16 ] shows that - at least for asthma maintenance - 1spray daily should be enough thus diminishing both costs and side effects. To obtain the best results, as most topical intranasal corticosteroids, it is strongly suggested to blow the nose to clear the passageway before the application or perform a nasal irrigation, and to avoid sneezing or blowing the nose right after spraying.
Intranasal corticosteroid therapy also has a beneficial effect in relieving eye symptoms in allergic conjunctivitis, similar to oral or intranasal antihistamines [ 19 — 21 ] according to reviews. Even though it has not been clearly assessed for MF in particular, its usage should improve other forms of rhinitis, like mixed forms or NARES.
Compared with antibiotics monotherapy, using MF nasal spray for initial ARS treatment, alone or combined with an antibiotic, has been demonstrated to reduce the recurrence rate and decrease the usage of related prescriptions and medical consultations [ 22 ]. As regards the treatment of nasal polyposis, MF, if administered daily, reduces polyp size and the nasal congestion, improving quality of life and sense of smell, with no unusual or unexpected adverse events [ 23 — 25 ].
Furthermore, regarding other minor complaints associated with rhinitis and rhinosinusitis, mometasone furoate nasal spray has been shown to be safe, effective and well tolerated in the treatment of daytime cough, too [ 26 ]. In , Minshall et al. Through nasal biopsies, they assessed that long-term administration of the drug attenuates the inflammatory process decreasing the extent of inflammatory cell infiltration especially eosinophils and did not determine changes in epithelial thickness or atrophy.
It has also been well established that the topical use of MF in the pediatric population shows great efficacy for management of adenoidal hypertophy [ 28 ] and otitis media with effusion [ 29 ], despite the concomitant presence of atopy [ 30 ].
Lastly, as reported in a recent cost-effectiveness analysis [ 31 ] when compared to beclomethasone diproprionate, the therapy with mometasone furoate for treating children suffering from allergic rhinitis showed a greater improvement, better efficacy, safety, and lower total treatment cost.
As regards the safety of the drug, the same results were obtained when administered in children for nasal polyps, even at double the recommended pediatric dosage for allergic rhinitis [ 32 ]. Pregnant women can safely use intranasal steroids. The sprays work only in the nasal passageway and the medicine does not affect other parts of the body unless too much is used [ 3 ]. Until now, despite parents apprehension, topical application of MF - respecting the recommended dosage - has not shown systemic effects.
Many studies have been conducted to investigate its effects on growth velocity and its potential to cause adrenal suppression [ 33 , 34 ]. Thus far, no significant difference has been reported and the current guidelines for asthma recommend inhaled corticosteroids for the control of mild to severe persistent asthma in adults as well as adolescents.
MF dry powder inhaler has been demonstrated to have an excellent safety and efficacy profile, and during post-marketing surveillance and in clinical trials no significant adverse side effects have been reported. In addition, its simple use seems to improve asthma management by addressing issues that generally inhibit proper adherence to therapy [ 35 — 38 ]. These considerations for the usage of MF in asthma could be extended to MF administered via the intranasal route.
Each steroid preparation comes with patient instructions for safe and effective use. For best results, the medication should be used following this direction carefully and according to medical advice. Adherence to long-term therapy is essential to have the desired results. In fact, intermittent therapy may not guarantee the same benefits. This is even more true in the case of a chronic disease.
Moreover, non-adherence to treatment may also require that, if an acute attack occurs, a higher dose of medication would be required, and possibly even asteroid molecule orally or intramuscularly administered. The large quantity of different preparations available could also allow the doctor - in case of molecules with the same efficacy, dosage and quality of the dispenser - to choose the most convenient for the patient, taking into account the expenses related with long term use.
Expenses are halved when analyzing children up to 11 years of age , due to the fact that the recommmended dosages are of one spray for each nostril once daily. Results were not always in favour of MF, but Meltzer et al.
Last but not least, it is a fact that all steroids suppress gene expression of factors responsible for generating and supporting inflammatory processes but furoates earn special attention as their lateral furoate ester chain makes the molecules highly lipophilic.
Thus, the moleculas are easily absorbed by mucous membranes, epithelium and cell membrane phospholipids. This minimizes their general action and maximizes local action [ 39 ]. MF has been demonstrated to be safe, effective and, if compared to its competitors, it shows symptom control greater than the other products in the market. Nasal congestion secondary to allergic rhinitis as a cause of sleep disturbance and daytime fatigue and the response to topical nasal corticosteroids.
J Allergy Clin Immunol. Intranasal steroid sprays in the treatment of rhinitis: is one better than another? J Laryngol Otol. The diagnosis and management of rhinitis: an updated practice parameter. Article PubMed Google Scholar. Intranasal corticosteroids versus topical H1 receptor antagonists for the treatment of allergic rhinitis: a systematic review with meta-analysis.
Ann Allergy Asthma Immunol. Clin Exp Allergy. A meta-analysis of sublingual allergen immunotherapy and pharmacotherapy in pollen-induced seasonal allergic rhinoconjunctivitis.
BMC Med. Intranasal fluticasone propionate is effective for perennial nonallergic rhinitis with or without eosinophilia. Huang A, Govindaraj S. Topical therapy in the management of chronic rhinosinusitis. Zalmanovici Trestioreanu A, Yaphe J. Intranasal steroids for acute sinusitis. Cochrane Database Syst Rev. PubMed Google Scholar. A preference evaluation study comparing the sensory attributes of mometasone furoate and fluticasone propionate nasal sprays by patients with allergic rhinitis.
Treat Respir Med. Preference evaluation and perceived sensory comparison of fluticasone furoate and mometasone furoate intranasal sprays in allergic rhinitis. Auris Nasus Larynx.
Allergic rhinitis is considered the most prevalent respiratory disease in Brazil and worldwide, with great impact on quality of life, affecting social life, sleep, and also performance at school and at work. To compare the efficacy and safety of two formulations containing mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis after four weeks of treatment. Phase III, randomized, non-inferiority, national, open study comparing mometasone furoate in two presentations control drug and investigational drug.
The primary endpoint was the percentage of patients with reduction of at least 0. Secondary outcomes included total nasal index score score after four and 12 weeks of treatment; individual scores for symptoms of nasal obstruction, rhinorrhea, sneezing, and nasal pruritus; as well as score for pruritus, lacrimation, and ocular redness after four and 12 weeks of treatment. The study was registered at clinicaltrials.
Adverse events were infrequent and with mild intensity in most cases. The efficacy and safety of investigational drug in the treatment of persistent allergic rhinitis were similar to the reference product, demonstrating its non-inferiority.
O estudo foi registrado em clinicaltrials. Eventos adversos foram pouco frequentes e de leve intensidade na maioria dos casos. Allergic rhinitis is an allergic disease characterized by chronic inflammation of the mucous membranes of the respiratory tract. Its main symptoms are nasal congestion, sneezing, anterior and posterior rhinorrhea, nasal pruritus, ocular and palatal pruritus, conjunctival injection, and lacrimation. Considered the most prevalent respiratory disease in Brazil and worldwide, recent estimates indicate that approximately million people suffer from allergic rhinitis.
Executive summary of joint task force practice parameters on diagnosis and management of rhinitis. Ann Allergy Asthma Immunol. In Brazil, it is estimated that the average prevalence in adolescents and schoolchildren is Clinical manifestations of allergic rhinitis occur after the interaction of a specific allergen and the immune system of previously sensitized individual.
Immediate hypersensitivity is a fast reaction with participation of IgE and mast cells followed by inflammation. Braz J Otorhinolaringol. Other allergic diseases may be associated with rhinitis, such as asthma and atopic dermatitis. Allergy and allergic diseases: second of two parts.
N Engl J Med. Allergic rhinitis management pocket reference Although benign, allergic rhinitis has a significant impact on quality of life, affecting social life, sleep, as well as school and labor performance. Ideally, the treatment of allergic rhinitis should aim primarily the action on cells and inflammatory mediators, thereby minimizing the symptoms of the disease. Several classes of drugs are used in the treatment, such as oral or topical antihistamines, intranasal decongestants, leukotriene receptor antagonists, and topical intranasal corticosteroids.
The latter are recognized as the first-choice drugs in anti-inflammatory treatment of moderate to severe allergic diseases. The mechanism of action of corticosteroids includes chemical mediators and cells involved in the allergic inflammatory process that establishes the rhinitis. Intranasal formulations have the advantage of local administration, with faster onset of action compared to systemic therapies.
Moreover, it has been reported that corticosteroids may help control comorbidities of rhinitis, such as allergic conjunctivitis and asthma. Efficacy of mometasone furoate nasal spray in the treatment of allergic rhinitis: meta-analysis of randomized, double-blind, placebo-controlled, clinical trials. Its intranasal application controls the initial and late allergic response.
Mometasone furoate: a review of its intranasal use in allergic rhinitis. Given the previously demonstrated efficacy of mometasone furoate in the treatment of allergic rhinitis, the present study was designed to test the non-inferiority of the new formulation compared to the control product. The primary objective was to compare the efficacy of both drugs in the treatment of persistent allergic rhinitis after four weeks.
This was a phase III, randomized, non-inferiority, national, multicenter seven centersopen study, aiming to compare the new experimental formulation of mometasone furoate Eurofarma to the control drug Nasonex rSchering-Plough Pharmaceuticals Ltd. The study was approved by the research ethics committees of the institutions involved under the number CE No. The study was conducted in open-label setting, with no blinding of interventions. Blinding prevents possible biases in clinical trials; however, sometimes it cannot be applied.
This study was open because the drugs studied have very different appearances, which would make the blinding infeasible. Nevertheless, the symptoms diary and the additional tests prevented the occurrence of any bias in the evaluation of the researchers.
Thus, the fact that this study was open does not impact the quality of data collected. Patients with severe comorbidities according to the investigator criteria ; moderate to severe persistent asthma; history of respiratory tract infection within 30 days prior to the study entry; structural changes causing nasal obstruction excessively deviated septum, nasal polyps, or any type of nasal malformation ; as well as patients in need of other medicines to treat allergic rhinitis; pregnant or lactating patients; active smokers in the last three months prior to enrollment in the study; and those who participated in another clinical study in the past 12 months were not included in the study.
After stratification according to the research center and to the intensity of allergic rhinitis mild versus moderate or severepatients were randomized in a ratio to receive one of the study treatments. The research subjects were randomized centrally, according to a list created by an application to generate random sequences. The randomization and allocation of treatment was conducted electronically through an electronic case report file CRF.
Treatment was automatically registered in the appropriate field on the medical records of the study. All randomized patients received at least one dose of study medication and received no different drug than that he or she was randomized to receive. The follow-up period for each patient was 14 weeks and the scheduled duration of active treatment was 12 weeks.
During the study, patients completed a diary containing information about the symptoms of allergic rhinitis, nasal obstruction, rhinorrhea, sneezing and nasal pruritus, as well as the score for pruritus, lacrimation, and ocular redness after four and 12 weeks of treatment, drug adherence, and use of rescue medications. At each visit the symptoms were rated on a scale from 0 to 3, which was summed to constitute the endpoint of NIS in the study period. The primary endpoint was the proportion of patients with a reduction of at least 0.
This threshold was defined based on the study conducted by Barnes et al. The minimal clinically important difference in allergic rhinitis. Clin Exp Allergy. Similar to the NIS, the TNSS is the sum of scores for a group of symptoms, each measured on an ordinal scale of 0, 1, 2, or 3, representing no symptoms, mild, moderate, or severe symptoms, respectively. Instead of 3, the TNSS combines the score of four symptoms nasal run, blockage, itchiness, and sneezeso it can range from 0 to As there was no such data on the MCID for the NIS, and in both scores, symptoms are individually scored from 0 to 3 and contribute equally to the total sum no different weight is attributed to different symptomsit was assumed that if a 0.
If a proportional extrapolation of the threshold was done, a reduction of 0. Thus, an approach using the threshold of 0. Secondary outcomes included total NIS score after four and 12 weeks of treatment; assessment of individual and overall scores for symptoms of nasal obstruction, rhinorrhea, and sneezing using NIS score; and assessment of scores of nasal pruritus and pruritus, lacrimation, and ocular redness performed by the investigator at each visit to the research center; as well as the frequency of adverse events.
To calculate NIS at baseline, the mean values of valid measures of the score for each patient in the seven days preceding the RV were used.
To calculate NIS after four weeks, the mean values of the fourth week of treatment were used, considering the data recorded in the diary. Each symptom was individually graded from 0 no symptom to 3 severe symptomsand the total NIS can range from 0 to 9.
Although the TNSS score is more frequently used, the NIS is a valid scale and has been used in several studies to assess the efficacy of intranasal corticosteroids in seasonal and perennial rhinitis.
For the per protocol PP population, the results obtained for nasal congestion obstructionrunny nose, and sneezing are shown as individual symptoms and as a combined score NIS. In addition to these three symptoms that constitute the NIS, patients had to grade in their diaries the other two symptoms one: nasal pruritus, and two: pruritus, lacrimation, and ocular rednesswhich were analyzed individually.
No imputation of missing data was taken. Continuous variables were summarized by means of variation minimum and maximummean, standard deviation SDmedian, and interquartile range IQR, 25th percentile, and 75th percentile. Categorical variables were described by means of relative frequencies. When comparing both groups, parametric or non-parametric methods were used, according to the distribution pattern of the outcome variables.
The Kolmogorov-Smirnov test with Lilliefors correction was used to assess the pattern of distribution of the outcome variables in the sample. Continuous variables with normal distribution were compared using t -tests, while non-normally distributed variables were compared using the Mann-Whitney non-parametric test.
Categorical variables were compared using the chi-squared or Fisher's exact test, according to the number of individuals. Analyses were performed using Microsoft Excel software Microsoft Office for descriptive analyses, and R statistical software v.
Based on the literature, the determination of sample size in the non-inferiority design of the study considered the NIS score after four weeks of equal treatment in both groups.
A non-inferiority margin M of The determination of the non-inferiority margin was based on the maximum acceptable difference between experimental and control groups, as judged by the specialists, in order to assure for the experimental group the retention of a minimum of the beneficial effect of treatment in relation to placebo or absence of medication.
Between May and Septembersubjects with mild, moderate, or severe persistent allergic rhinitis, classified according to the ARIA criteria, were included in the study, and of them were randomized to receive one of the study drugs. The reasons for randomization failure are shown in Table 1. Thumbnail Table 1 Reasons for randomization failure. All subjects enrolled received at least one dose of the study medication and none had received a different drug than the one established.
All of the randomized patients received at least one dose of the study medication and entered the safety sample. One randomized subject violated an eligibility criterion and the study was discontinued at the time the violation became known. The ITT population was therefore composed of patients, the PP population of patients, and the safety population of patients. The demographic characteristics of patients are presented in Table 2.
In addition to these symptoms, patients had to grade in their diaries the other two symptoms: nasal pruritus; and pruritus, lacrimation, and ocular redness; which were analyzed individually. There was no significant difference between the groups, except for nasal obstruction: according to the data recorded in the diary, the score for nasal obstruction at baseline was significantly higher in the investigational arm than in the control arm Fig.
Figure 2 Symptom score. The efficacy primary analysis was performed by evaluating the non-inferiority of the investigational drug compared to the control drug. Table 3 shows the comparison between the success rates in the two treatment groups in PP population.
It can be observed that Thus, the non-inferiority of the investigational drug compared to the control drug was demonstrated. The values of NIS score in the investigational arm were 5. The group treated with the control drug showed a NIS score of 5. After the beginning of the treatment, There was no significant difference between the treatment arms.
Table 4 shows the level of serum cortisol in the beginning of the study SV and after four weeks of treatment FV in both treatment groups, considering the safety population. The comparison of medians showed no significant difference between groups in the beginning or in the end of treatment.
Mometasone furoate is a synthetic corticosteroid which has been evaluated for intranasal use in the treatment of adults and children with allergic rhinitis. Mometasone furoate (Nasonex) is a high-potency intranasal corticosteroid available for the treatment and/or prophylaxis of the nasal symptoms of seasonal. Mometasone furoate is a synthetic corticosteroid which has been evaluated for intranasal use in the treatment of adults and children with allergic rhinitis. Mometasone furoate (Nasonex) is a high-potency intranasal corticosteroid available for the treatment and/or prophylaxis of the nasal symptoms of seasonal. Mometasone furoate aqueous nasal spray is a synthetic steroid assessed for intranasal use in the therapy of adults and children affected by AR. Such topical. Blinding prevents possible biases in clinical trials; however, sometimes it cannot be applied. Relief of cough and nasal symptoms associated with allergic rhinitis by mometasone furoate nasal spray. Intranasal corticosteroids for asthma control in people with coexisting asthma and rhinitis. Even though it has not been assessed for MF in particular, topical steroids are the most appropriate treatment in mixed rhinitis and NARES. As there was no such data on the MCID for the NIS, and in both scores, symptoms are individually scored from 0 to 3 and contribute equally to the total sum no different weight is attributed to different symptomsit was assumed that if a 0. Article PubMed Google Scholar.Back to Medicines A to Z. Mometasone nasal nose spray is used to treat cold-like symptoms caused by allergic rhinitis. This is inflammation of the inside of the nose that can be brought on by hay fever. Mometasone is also used to treat other conditions, such as nasal polyps in adults. Mometasone is a type of medicine known as a steroid or corticosteroid.
Corticosteroids are a copy of a hormone that your body makes naturally. They are not the same as anabolic steroids. Mometasone nasal spray is available on prescription for adults and children. Adults can buy it from pharmacies for treating symptoms caused by allergic rhinitis, where it is often sold as Clarinaze. Most adults can use mometasone nasal spray for nasal polyps, allergic rhinitis and hay fever.
Children aged 3 years and over can use mometasone nasal spray for allergic rhinitis and hay fever. Mometasone is not suitable for some people. To make sure this nasal spray is safe for you, tell your doctor if you:.
For allergic rhinitis the usual dose is 1 or 2 sprays into each nostril once a day. Do not use more than 2 sprays per nostril in 24 hours. For nasal polyps the usual dose is 1 or 2 sprays into each nostril once or twice a day.
Do not use more than 4 sprays per nostril in 24 hours. If you're using a new bottle, it may not work first time. Pump the spray a few times until a fine mist comes out. You'll also need to do this if the bottle has not been used for a few days. After using your spray, wipe the nozzle with a clean tissue and replace the cap. You'll be able to use your nasal spray less often once your symptoms are under control. For example, you might go from using 2 sprays in each nostril once a day, to 1 spray in each nostril once a day.
You may need to increase your dose again if your symptoms get worse after reducing it. If you have mometasone nasal spray on prescription, your doctor will tell you how often to use the nasal spray and when to change your dose.
If you forget to take a dose, use it as soon as you remember. Unless it's almost time for your next dose, in which case skip the missed dose and take your next one as usual. If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.
Using too much mometasone nasal spray by accident is unlikely to harm you. Like all medicines, mometasone can cause side effects although not everyone gets them. With mometasone nasal spray, very little medicine is absorbed into the rest of your body, so it's not likely to give you serious side effects. Ask your doctor if you need to carry a steroid emergency card. Keep taking the medicine but talk to your doctor if these side effects bother you or do not go away:.
Very few people have serious side effects when using mometasone nasal spray. You are more likely to have a serious side effect if you use high doses of mometasone for more than a few months. It's possible to have a serious allergic reaction anaphylaxis to mometasone. These are not all the side effects of mometasone. See the leaflet inside your medicine's packet for a full list. You can report any suspected side effect to the UK safety scheme.
There's no clear evidence that mometasone will harm your unborn baby. For safety, your doctor will only prescribe mometasone in pregnancy if the benefits outweigh the risks. They will prescribe the lowest dose that works for you. If you're pregnant, speak to your doctor before buying mometasone nasal spray at a pharmacy or supermarket.
However, always check with your doctor first. Your baby may need extra monitoring if you use mometasone nasal spray twice a day for more than a few months. For more information about how using a steroid nasal spray might affect you and your baby during pregnancy, read this leaflet on treating allergic rhinitis on the Best Use of Medicines in Pregnancy BUMPs website.
Some medicines and mometasone can affect each other. This can increase your chances of side effects, or it may mean changing your mometasone dose. There's very little information about taking herbal remedies and supplements while taking mometasone. Ask a pharmacist for advice. Tell your doctor or pharmacist if you're taking any other medicines, including herbal remedies, vitamins or supplements.
Mometasone is a steroid corticosteroid medicine. Steroids closely copy the effects of natural hormones produced in your adrenal glands. The adrenal glands are above your kidneys. Mometasone works on your immune system to reduce the symptoms of inflammatory conditions and allergic reactions, such as redness, swelling and itching. The nasal spray reduces swelling and mucus in your nose.
It can take a little longer to work than antihistamine sprays but the effects last for longer. If you're using it to treat nasal polyps, mometasone will reduce swelling and reduce the size of the polyps. You will not notice any immediate improvement in your symptoms when you first start using mometasone nasal spray.
It takes a few days for a steroid nasal spray to start working. It can take several weeks to reach its full effect. If you use the spray for hay fever it is best to start using it at least a couple of weeks before the hay fever season starts. If you buy mometasone nasal spray from a pharmacy or supermarket, check the leaflet that comes with the medicine.
This will tell you how long you can use it for. You can usually use it for up to 3 months, but tell your doctor if you feel no better after using it for 14 days. If you are prescribed mometasone, your doctor may advise you to use it for longer. Mometasone is unlikely to have any lasting harmful effects if you follow the instructions that come with your medicine, or use it as recommended by your doctor. However, children and teenagers need to have their height and weight monitored carefully if they're using high doses of a steroid nasal spray like mometasone for a long time.
Taking mometasone for a long time can slow down their normal growth. The nasal spray delivers a small amount of steroid medicine exactly where you need it. This limits the amount of steroid reaching the rest of your body.
It also keeps the risk of side effects as low as possible. If you're using steroid medicines such as mometasone, your adrenal glands may not make as much of some of the hormones your body needs such as cortisol known as the stress hormone. This is known as adrenal insufficiency. This card is the size of a credit card and fits in your wallet or purse. If you need any medical or dental treatment, or are having surgery or an invasive procedure, show your steroid emergency card to your doctor or dentist.
This is important so they know you're having steroid treatment and can give you extra steroids as needed.
Mometasone does not affect any type of contraception, including the contraceptive pill and emergency contraception. There's no clear evidence to suggest that using mometasone will reduce fertility in either men or women.
However, speak to a pharmacist or your doctor if you are trying to get pregnant. For most people, taking mometasone nasal spray will not affect their ability to drive a car or cycle. Page last reviewed: 28 July Next review due: 28 July Mometasone nasal spray - Brand names: Clarinaze, Nasonex On this page About mometasone nasal spray Key facts Who can and cannot take mometasone nasal spray How and when to take mometasone nasal spray Side effects of mometasone nasal spray How to cope with side effects of mometasone nasal spray Pregnancy and breastfeeding Cautions with other medicines Common questions about mometasone nasal spray.
About mometasone nasal spray Mometasone nasal nose spray is used to treat cold-like symptoms caused by allergic rhinitis. It also comes as: a cream, ointment or scalp lotion for eczema and psoriasis an inhaler puffer for asthma skin treatments for eczema and psoriasis.
You need to use mometasone nasal spray regularly for it to work. It works by reducing swelling and irritation in your nose. The most common side effects are an unpleasant smell and a dry or sore nose or throat. Unders can only use mometasone nasal spray if their doctor prescribes it. If your doctor has prescribed high doses of mometasone to control your symptoms you may need to carry a steroid emergency card.
Ask your pharmacist or doctor. To make sure this nasal spray is safe for you, tell your doctor if you: are allergic to mometasone or any other medicines are taking or have recently taken other steroid medicines have had nose surgery have an infection in your nose are pregnant or trying to get pregnant have ever had TB tuberculosis have ever had glaucoma or cataracts.
Mometasone nasal spray needs to be used regularly for it to work. How to use it Follow the instructions that come with your nasal spray. Gently shake the bottle and remove the cap. Blow your nose gently, then close one nostril with your finger. Bend your head forward slightly and carefully put the nozzle into your other nostril. Slowly breathe in through your nose and press down on the widest part of the nozzle to squirt the spray once.
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