Can singulair and prednisone. Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma

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Study record managers: refer to the Data Element Definitions if submitting registration or results information. Asthma will be defined as at least the second episode of wheezing, with signs of lower airway obstruction.

At discharge from ED children will be randomized to two interventional groups. The primary outcome will be therapeutic failure in the two groups from randomization to day 8. This failure will be defined as unscheduled medical visits for asthma symptoms or hospitalization or treatment with oral corticosteroids outside the experimental protocol. This study will take two 9 months periods.

Secondary analyses will include repeated measures ANOVA for differences in changes of continuous variables and the Fisher's Exact test for comparison of proportions. An exploratory sub-group logistic regression analysis will be done for examining interaction between the main treatment effect and possible covariates. In the event that the patients given a single dose of prednisolone followed by Montelukast have comparable therapeutic failure rate to those given standard extended prednisolone therapy, administration of Montelukast may help us abbreviate the length of corticosteroid therapy in children with acute asthma.

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 Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : May 13, Study Description. The primary objective of this study is to evaluate if children with acute asthma given a single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast will achieve a therapeutic failure rate at day 8 not significantly higher than those given six daily doses of oral prednisolone.

Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8. Detailed Description:. Drug Information available for: Prednisolone Montelukast. 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.

This population may eventually have diagnoses other than asthma or viral induced wheezing Patients who received more than a single dose of oral corticosteroids within 72 hours prior to arrival Patients receiving more than mcg per day of fluticasone for more than 1 month or more than mcg of fluticasone for more than 7 days prior to arrival Patients who have had more than 2 previous visits to the asthma clinic at SickKids Patients who received Montelukast within one week of arrival Critically ill patients requiring airway stabilization Patients with severe asthma, defined as PI 12 to 15 or PRAM 9 to Co-existent co-morbidities such as chronic pulmonary disease and cardiac disease requiring pharmacotherapy, neurologic disease and immune disorders.

Previous admission to ICU for asthma. More than 3 hospitalizations for asthma during the past 12 months. Contact with varicella within the previous 21 days.

Insufficient command of the English language. 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. Can montelukast shorten prednisolone therapy in children with mild to moderate acute asthma? A randomized controlled trial. J Pediatr. Epub Aug 4. 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.

Asthma, Bronchial. Drug: Montelukast plus prednisolone Drug: Prednisolone. Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Drug: Montelukast plus prednisolone Single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast.

Drug: Prednisolone Six daily doses of oral prednisolone. September 21, Key Record Dates.

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  Search for terms. Asthma, Bronchial. Studies in animals have not shown evidence of an increased occurrence of fetal damage. J Pediatr.     ❾-50%}

 

- Drug and Food Interactions



    Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8. Insufficient command of the English language. Study Type :. Asthma, Bronchial. An exploratory sub-group logistic regression analysis will be done for examining interaction between the main treatment effect and possible covariates. Usually avoid combinations; use it only under special circumstances. This failure will be defined as unscheduled medical visits for asthma symptoms or hospitalization or treatment with oral corticosteroids outside the experimental protocol.

Asthma will be defined as at least the second episode of wheezing, with signs of lower airway obstruction. At discharge from ED children will be randomized to two interventional groups.

The primary outcome will be therapeutic failure in the two groups from randomization to day 8. This failure will be defined as unscheduled medical visits for asthma symptoms or hospitalization or treatment with oral corticosteroids outside the experimental protocol. This study will take two 9 months periods. Secondary analyses will include repeated measures ANOVA for differences in changes of continuous variables and the Fisher's Exact test for comparison of proportions.

An exploratory sub-group logistic regression analysis will be done for examining interaction between the main treatment effect and possible covariates. In the event that the patients given a single dose of prednisolone followed by Montelukast have comparable therapeutic failure rate to those given standard extended prednisolone therapy, administration of Montelukast may help us abbreviate the length of corticosteroid therapy in children with acute asthma.

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 Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Last Update Posted : May 13, Study Description. The primary objective of this study is to evaluate if children with acute asthma given a single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast will achieve a therapeutic failure rate at day 8 not significantly higher than those given six daily doses of oral prednisolone.

Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8. Detailed Description:. Drug Information available for: Prednisolone Montelukast. FDA Resources. Arms and Interventions. Outcome Measures.

Eligibility Criteria. Results: The rates of treatment failure were 7. Treatment was more likely to fail in younger patients odds ratio, 4.

In the montelukast group, more patients received additional pharmacotherapy than in patients receiving prednisolone Conclusion: Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma. This population should receive oral corticosteroids after discharge.

No drug interactions were found for selected drugs: prednisoneSingulair. No food interactions were found for selected drugs: prednisoneSingulair. The following applies to the ingredients: Prednisone. This drug should only be used during pregnancy if the benefit outweighs the potential risk to the fetus.

Comments: -Observe for signs and symptoms of hypoadrenalism in infants exposed to this drug in utero. Teratogenicity including increased incidence of cleft palate have occurred in animal studies.

A number of cohort and case controlled studies in humans suggest maternal corticosteroid use in the first trimester produces a slight increased risk of cleft lip with or without cleft palate increased from 1 out of to 3 to 5 out of infants.

Reduced placental and birth weight have been recorded in animals and humans after long term treatment. There is the possibility of adrenal cortex suppression in the newborn with long term use in the mother; however the short term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant.

Maternal pulmonary edema has been reported with inhibition of uterine contractions and fluid overload. There are no adequate and well controlled studies in pregnant women. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

The following applies to the ingredients: Montelukast found in Singulair. Animal studies of oral administration during organogenesis at up to times the maximum recommended human daily oral dose did not cause any averse developmental effects. Human data from prospective and retrospective cohort studies have not identified an increase in major birth defects when this drug was used during pregnancy; limitations of the studies include small sample size, retrospective data collection, and inconsistent comparator groups.

There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy.

Comments: -If this drug is necessary, the lowest dose should be prescribed; theoretically, if high maternal doses are necessary, the dose the infant receives may be minimized by avoiding breastfeeding for 4 hours following dosing and using prednisolone instead of prednisone.

Amounts of glucocorticoids excreted into breast milk are low with a total infant daily dose calculated to be up to 0. If this drug is necessary, the lowest dose should be prescribed as high doses of corticosteroids for long periods could produce infant growth and development problems and interfere with endogenous corticosteroid production. High doses might occasionally cause temporary loss of milk supply. Comments: -A published study reports presence of this drug in human milk.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

Switch to: Professional Interactions. These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication. Disclaimer: This content should not be considered complete and should not be used in place of a call or visit to a healthcare professional.

Medication List Close prednisone Singulair. Show 4 interactions. This does not necessarily mean no interactions exist. Always consult your healthcare provider. Drug and Food Interactions No food interactions were found for selected drugs: prednisoneSingulair.

Drug and Pregnancy Interactions Open all sections. References "Product Information. Deltasone prednisone. Rayos prednisone. PredniSONE prednisone. The following applies to the ingredients: Montelukast found in Singulair Professional Content The manufacturer makes no recommendation regarding use during pregnancy. Singulair montelukast. Montelukast Sodium montelukast. Open all sections. The following applies to the ingredients: Prednisone Professional Content This drug should be used only if clearly needed Excreted into human milk: Yes Comments: -If this drug is necessary, the lowest dose should be prescribed; theoretically, if high maternal doses are necessary, the dose the infant receives may be minimized by avoiding breastfeeding for 4 hours following dosing and using prednisolone instead of prednisone.

Toxicology Data Network. The following applies to the ingredients: Montelukast found in Singulair Professional Content The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Yes Comments: -A published study reports presence of this drug in human milk.

Facebook Twitter Email Print. Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.

Minimally clinically significant.

Prescription only. Montelukast may be used on a daily basis for the maintenance treatment of asthma or allergic rhinitis. It will not relieve an acute asthma. prednisone and montelukast oral. prednisone will decrease the level or effect of montelukast oral by altering drug metabolism. Prednisolone, montelukast, and omalizumab were found to be effective in controlling the allergic symptoms of allergic rhinitis and upper/lower airway. Singulair (montelukast) is an oral medication that can be used to treat treatment for asthma usually involves inhaled steroids. Conclusion: Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma. Drug: Montelukast plus prednisolone Drug: Prednisolone.

Objective: To examine whether outpatient post-stabilization therapy with montelukast produces more treatment failures than prednisolone. Study design: In this randomized, double-blind, double-dummy non-inferiority trial, children 2 to 17 years of age with mild to moderate acute asthma stabilized with prednisolone in the emergency department received 5 daily treatments with either prednisolone or montelukast after discharge. The primary outcome was treatment failure within 8 days ie, an asthma-related unscheduled visit, hospitalization, or additional systemic corticosteroids.

Results: The rates of treatment failure were 7. Treatment was more likely to fail in younger patients odds ratio, 4. In the montelukast group, more patients received additional pharmacotherapy than in patients receiving prednisolone Conclusion: Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma.

This population should receive oral corticosteroids after discharge. Trial registration: ClinicalTrials. Abstract Objective: To examine whether outpatient post-stabilization therapy with montelukast produces more treatment failures than prednisolone.

Associated data ClinicalTrials.



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