Bronchoprotection Effect of Montelukast in Children With Persistent Allergic Rhinitis
Primary hypothesis: Montelukast will decrease bronchial hyperresponsiveness in subjects with persistent allergic rhinitis when compared with those treated with placebo in a double- blind, placebo-controlled, cross-over 5-week randomized trial.
Secondary hypothesis: There will be a significant correlation between allergic rhinitis severity and bronchial hyperresponsiveness severity and baseline lung function measures.
Tertiary hypothesis: Subjects who respond well to montelukast will have particular characteristics of allergic rhinitis when compared with those who do not respond to montelukast.
|Rhinitis, Allergic, Perennial||Drug: Montelukast to placebo Drug: Placebo to montelukast|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Double-blind, Randomized, Cross-over Design Study to Compare the Bronchoprotection Effect of Montelukast Versus Placebo in Preschool Children With Persistent Allergic Rhinitis Without Overt Asthma Symptoms Using Bronchial Challenge Test|
- dose response slope of Xrs5 [ Time Frame: up to 5 weeks ]
- Spirometric and IOS value [ Time Frame: up to 5 weeks ]
- The spirometric secondary outcome measures are changes in PD20_FEV1 or DRS_FEV1.
- The impulse oscillometric secondary outcome measures are change in PD80_Xrs5.
|Study Start Date:||May 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: montelukast to placebo||
Drug: Montelukast to placebo
Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
Other Name: SINGULAIR 4mg or 5mg
|Active Comparator: Placebo to montelukast||
Drug: Placebo to montelukast
Subjects will receive matching placebo. Each treatment period consists of 2 weeks
Other Name: SINGULAIR 4mg or 5mg matching placebo
This study is a randomized, double-blind, placebo-controlled, cross-over, multicenter (2 institutes) study with a washout period of at least 1 wk between each study period. Subjects with persistent allergic rhinitis, defined by the recommendations of the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, and assessed on historical data, will be recruited. Persistent allergic rhinitis means that the symptoms are present more than 4 days a week and for more than 4 consecutive weeks.
Inclusion criteria will be persistent rhinitis patients (preschool children, 3-6 years), children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study and children without overt asthma or chronic respiratory symptoms. Exclusion criteria will be the following: any prior documented history of asthma or referred asthma symptoms within 1 year, respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, impaired FEV1 values (such as <80% of the predicted), <0.75 FEV1/FVC ratio, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581710
|Principal Investigator:||Man Yong Han||specify Unaffiliated|