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Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.

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ClinicalTrials.gov Identifier: NCT01581710
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Man Yong Han, CHA University

Brief Summary:
This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.

Condition or disease Intervention/treatment Phase
Mild Persistent Asthma Drug: Montelukast to placebo Drug: Placebo to montelukast Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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 Lung Function Measure of Montelukast Versus Placebo in Children With Mild Persistent Asthma
Study Start Date : May 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: montelukast to placebo
14 days
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
No Intervention: Washout
14 days
Active Comparator: Placebo to montelukast
14 days
Drug: Placebo to montelukast
Subjects will receive matching placebo. Each treatment period consists of 2 weeks
Other Name: SINGULAIR 4mg or 5mg matching placebo



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Baseline Lung Function in MMEF [ Time Frame: up to 2 weeks ]
    Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.gov identifier (NCT number): NCT01581710


Sponsors and Collaborators
CHA University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Man Yong Han specify Unaffiliated

Responsible Party: Man Yong Han, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01581710     History of Changes
Other Study ID Numbers: CHA-121
First Posted: April 20, 2012    Key Record Dates
Results First Posted: April 12, 2018
Last Update Posted: April 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Man Yong Han, CHA University:
Leukotriene Antagonists
Bronchodilator response

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action