- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01581710
Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.
A Double-blind, Randomized, Cross-over Design Study to Compare the Lung Function Measure of Montelukast Versus Placebo in Children With Mild Persistent Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period.
After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test.
Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children diagnosed with mild persistent asthma patients based on the GINA guidelines
- children old enough to cooperate in performing pulmonary function testing
- legal guardians who sufficiently listen to the purpose and voluntarily agree with the participation to sign a written consent approved by IRB
- children with no respiratory symptoms 4 weeks prior to the beginning of the study
- children without chronic respiratory symptoms.
Exclusion Criteria:
- 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 in past 4 weeks.
- admission or visit of the emergency department in past 4 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: montelukast to placebo
14 days
|
Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
Other Names:
|
No Intervention: Washout
14 days
|
|
Active Comparator: Placebo to montelukast
14 days
|
Subjects will receive matching placebo.
Each treatment period consists of 2 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
Time Frame: up to 2 weeks
|
Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator
|
up to 2 weeks
|
Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)
Time Frame: up to 2 weeks
|
Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator
|
up to 2 weeks
|
Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator
Time Frame: up to 2 weeks
|
Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator
|
up to 2 weeks
|
Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)
Time Frame: up to 2 weeks
|
Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator
|
up to 2 weeks
|
Baseline Lung Function of FEV1 Before the Bronchodilator
Time Frame: up to 2 weeks
|
baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator
|
up to 2 weeks
|
Baseline Lung Function of FEV1/FVC Before the Bronchodilator
Time Frame: up to 2 weeks
|
baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator
|
up to 2 weeks
|
Baseline Lung Function in MMEF
Time Frame: up to 2 weeks
|
Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator
|
up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative Change (%) of FEV1 After the Bronchodilator
Time Frame: up to 2 weeks
|
Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100
|
up to 2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Man Yong Han, specify Unaffiliated
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- CHA-121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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