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Mometasone formoterol merck. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate
Decreases in bone mineral density BMD have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate, a component of DULERA.
Patients with major risk factors for decreased BMD should be monitored and treated with established standards of care. Inhaled corticosteroids, including DULERA, may cause a reduction in growth velocity when administered in pediatric patients. Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term inhaled corticosteroids, including mometasone furoate, a component of DULERA.
DULERA, like other medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.
Doses of the related beta 2 -agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. Be alert to hypokalemia and hyperglycemia as beta 2 -agonist medications such as DULERA have the potential to produce adverse cardiovascular effects.
Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than countries to deliver innovative health solutions.
We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www. Private Securities Litigation Reform Act of There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Unsubscribe from email alerts. We are committed to providing leading innovations for today and the future that save and improve lives around the world. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful.
No Duty to Update The information contained in this website was current as of the date presented. The company assumes no duty to update the information to reflect subsequent developments.
All but one of these events was considered by the investigator to be unrelated to the study drug. The exposure adjusted mortality rates over the week period were 2. DULERA mometasone furoate and formoterol fumarate dihydrate Inhalation Aerosol is indicated for the treatment of asthma in patients 12 years and older. It is not indicated for the relief of acute bronchospasm. DULERA combines mometasone furoate, an inhaled corticosteroid, and formoterol fumarate, a long-acting beta2-agonist. It is a pressurized metered-dose inhaler with a built-in numeric counter that shows the number of remaining doses.
Each inhalation contains 5 mcg of formoterol fumarate and either mcg or mcg of mometasone furoate. The recommended starting dose in the treatment of asthma is based on prior asthma therapy.
Data from a large placebo-controlled U. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.
When treating patients with asthma, prescribe DULERA only for patients with asthma not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA.
Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy e. DULERA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Increasing use of inhaled, short-acting beta2-agonists is a marker for deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen. Patients using DULERA should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason. Oropharyngeal candidiasis may occur. If candidiasis develops, it should be treated with appropriate antifungal therapy, but at times therapy with DULERA may need to be interrupted.
Advise patients to rinse the mouth after inhalation. DULERA should be used with caution in patients with tuberculosis, fungal, bacterial, viral including chicken pox or measles , or parasitic infections; or ocular herpes simplex infections because of the potential for worsening of these infections.
A more serious or even fatal course of chickenpox or measles can occur in susceptible patients. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Formoterol is a long-acting beta 2 agonist LABA , which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events hospitalization, intubation and death compared to participants taking an ICS alone.
Detailed Description:. Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Inclusion Criteria: Persistent asthma for at least 1-year Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid ICS with or without a long-acting beta agonist LABA or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist LTRA , xanthine or short acting beta agonist SABA as a monotherapy. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. Epub Dec 8.
❿DULERA® (mometasone furoate and formoterol fumarate dihydrate) Official Site.
Cindy Weinstein, senior principal scientist, clinical research, respiratory and immunology, Merck Research Laboratories. Merck is grateful to all of the investigators and patients who participated. This study began in as a post-marketing requirement from the U. Randomized patients had to have a history of one to four asthma exacerbations in the past year, but none during the previous month. Patients with unstable asthma or a history of life-threatening asthma were excluded.
No asthma-related intubations or asthma-related deaths were observed. MF group was 1. MF group was 0. Merck conducted the study at centers in 35 countries with scientific and operational oversight from an independent joint oversight steering committee. Data from a large placebo-controlled U.
This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When treating patients with asthma, prescribe DULERA only for patients whose asthma is not adequately controlled on a long-term asthma controller medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA.
Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy e. DULERA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Increasing use of inhaled, short-acting beta 2 -agonists is a marker for deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen. Patients using DULERA should not use additional formoterol or other long-acting inhaled beta 2 -agonists for any reason.
Oropharyngeal candidiasis may occur. If candidiasis develops, it should be treated with appropriate antifungal therapy, but at times therapy with DULERA may need to be interrupted.
Advise patients to rinse the mouth after inhalation. DULERA should be used with caution in patients with tuberculosis, fungal, bacterial, viral including chicken pox or measlesor parasitic infections, or ocular herpes simplex infections because of the potential for worsening of these infections.
A more serious or even fatal course of chickenpox or measles can occur in susceptible patients. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Hypercorticism and adrenal suppression may occur with very high dosages of DULERA or at the regular dosage in susceptible individuals. There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. DULERA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Decreases in bone mineral density BMD have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate, a component of DULERA.
Patients with major risk factors for decreased BMD should be monitored and treated with established standards of care. Inhaled corticosteroids, including DULERA, may cause a reduction in growth velocity when administered in pediatric patients.
Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term inhaled corticosteroids, including mometasone furoate, a component of DULERA. DULERA, like other medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.
Doses of the related beta 2 -agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. Be alert to hypokalemia and hyperglycemia as beta 2 -agonist medications such as DULERA have the potential to produce adverse cardiovascular effects.
Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www. Private Securities Litigation Reform Act of There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Unsubscribe from email alerts. We are committed to providing leading innovations for today and the future that save and improve lives around the world.
There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful.
No Duty to Update The information contained in this website was current as of the date presented. The company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date.
By continuing, you will be directed to a site intended only for residents of the United States and Canada. Sign up for email alerts. Related links. Company Statements Read our latest company statements. Media library Access videos, logos, photos, and infographics. About Merck We are committed to providing leading innovations for today and the future that save and improve lives around the world.
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Study record managers: refer to the Data Element Definitions if submitting registration or results information. To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment or 7 days after the last treatment dose, whichever occurred later. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.
The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment modified intention-to-treat. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant. Intubation was defined as endotracheal intubation only. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : January 5, Last Update Posted : February 9, Study Description. Mometasone is an inhaled corticosteroid ICSwhich reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist LABAwhich helps to relax the muscles of the airways in the lungs, making it easier to breathe.
In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events hospitalization, intubation and death compared to participants taking an ICS alone.
Detailed Description:. Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Persistent asthma for at least 1-year Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid ICS with or without a long-acting beta agonist LABA or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist LTRAxanthine or short acting beta agonist SABA as a monotherapy.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. Epub Dec 8. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Phase 4. Study Type :. Interventional Clinical Trial. Actual Enrollment :. P Also Known as P Actual Study Start Date :.
Actual Primary Completion Date :. Actual Study Completion Date :. November 16, Key Record Dates.
DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol is indicated for the treatment of asthma in patients 12 years and older. It is. Merck Announces Top-Line Results from the Long Term LABA Safety Study of DULERA (mometasone furoate and formoterol fumarate dihydrate). FDA Approves Merck's DULERA(R) (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of. Affiliations. 1 Respiratory and Immunology Clinical Development, Kenilworth, NJ. Electronic address: localhostein@localhost In combination, mometasone and formoterol are used for the treatment of asthma. Study Director: Medical Director, Merck Sharp & Dohme LLC. Related links. Please see the Terms and Conditions. Talk with your doctor and family members or friends about deciding to join a study. Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term inhaled corticosteroids, including mometasone furoate, a component of DULERA. Slowed growth in children. Sign up for email alerts.Dennis E. Doherty, M. Fish, M. Scheduled assessments included screening Day 14 ; baseline Day 1 ; and Weeks 1, 4, 13, and At one year 52 weeks , no notable differences in the incidence or nature of adverse events were reported versus those reported during the first 26 weeks.
The majority of treatment-related adverse events were mild to moderate in severity. The most common treatment-related adverse events across all active treatment groups over 52 weeks were oral fungal infection 1.
During the treatment period, 28 1. The exposure-adjusted pneumonia including all types rates over the week period were 3. All but one of these events was considered by the investigator to be unrelated to the study drug. The exposure adjusted mortality rates over the week period were 2. DULERA mometasone furoate and formoterol fumarate dihydrate Inhalation Aerosol is indicated for the treatment of asthma in patients 12 years and older.
It is not indicated for the relief of acute bronchospasm. DULERA combines mometasone furoate, an inhaled corticosteroid, and formoterol fumarate, a long-acting beta2-agonist. It is a pressurized metered-dose inhaler with a built-in numeric counter that shows the number of remaining doses. Each inhalation contains 5 mcg of formoterol fumarate and either mcg or mcg of mometasone furoate.
The recommended starting dose in the treatment of asthma is based on prior asthma therapy. Data from a large placebo-controlled U. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When treating patients with asthma, prescribe DULERA only for patients with asthma not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA.
Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy e. DULERA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Increasing use of inhaled, short-acting beta2-agonists is a marker for deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen.
Patients using DULERA should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason. Oropharyngeal candidiasis may occur. If candidiasis develops, it should be treated with appropriate antifungal therapy, but at times therapy with DULERA may need to be interrupted.
Advise patients to rinse the mouth after inhalation. DULERA should be used with caution in patients with tuberculosis, fungal, bacterial, viral including chicken pox or measles , or parasitic infections; or ocular herpes simplex infections because of the potential for worsening of these infections.
A more serious or even fatal course of chickenpox or measles can occur in susceptible patients. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Hypercorticism and adrenal suppression may occur with very high dosages of DULERA or at the regular dosage in susceptible individuals. Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. DULERA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Decreases in bone mineral density BMD have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate, a component of DULERA. Patients with major risk factors for decreased BMD should be monitored and treated with established standards of care. Inhaled corticosteroids, including DULERA, may cause a reduction in growth velocity when administered in pediatric patients. Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term inhaled corticosteroids, including mometasone furoate, a component of DULERA.
DULERA, like other medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
Be alert to hypokalemia and hyperglycemia as beta2-agonist medications such as DULERA have the potential to produce adverse cardiovascular effects. COPD includes two main conditions — emphysema and chronic bronchitis — which are characterized by damage and inflammation that reduces airflow in and out of the lungs, making it difficult to breathe.
Common symptoms include coughing that produces large amounts of mucus, wheezing, shortness of breath and chest tightness. COPD is a progressive disease, meaning it gets worse over time. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.
For more information, visit www. Actual results may differ from those set forth in the forward-looking statements. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. July, Unsubscribe from email alerts. We are committed to providing leading innovations for today and the future that save and improve lives around the world. Private Securities Litigation Reform Act of There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful.
If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
No Duty to Update The information contained in this website was current as of the date presented. The company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date. By continuing, you will be directed to a site intended only for residents of the United States and Canada. About COPD COPD includes two main conditions — emphysema and chronic bronchitis — which are characterized by damage and inflammation that reduces airflow in and out of the lungs, making it difficult to breathe.
Sign up for email alerts. Related links. Company Statements Read our latest company statements. Media library Access videos, logos, photos, and infographics. About Merck We are committed to providing leading innovations for today and the future that save and improve lives around the world. Decline Accept. You are leaving Merck. Cancel Continue. Welcome to Merck.
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