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Bronchoprotection Effect of Montelukast in Children With Persistent Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT01581710
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : January 28, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Man Yong Han, CHA University

Brief Summary:

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.


Condition or disease Intervention/treatment
Rhinitis, Allergic, Perennial Drug: Montelukast to placebo Drug: Placebo to montelukast

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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 Bronchoprotection Effect of Montelukast Versus Placebo in Preschool Children With Persistent Allergic Rhinitis Without Overt Asthma Symptoms Using Bronchial Challenge Test
Study Start Date : May 2012
Primary Completion Date : September 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. dose response slope of Xrs5 [ Time Frame: up to 5 weeks ]

Secondary Outcome Measures :
  1. Spirometric and IOS value [ Time Frame: up to 5 weeks ]
    1. The spirometric secondary outcome measures are changes in PD20_FEV1 or DRS_FEV1.
    2. The impulse oscillometric secondary outcome measures are change in PD80_Xrs5.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children diagnosed with persistent rhinitis 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 overt asthma or chronic respiratory symptoms.

Exclusion Criteria:

  • any prior documented history of asthma or referred asthma symptoms within 1 year
  • respiratory symptoms suggestive of bronchial asthma, such as chronic 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 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
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Man Yong Han, CHA University:
Leukotriene Antagonists
Bronchial Hyperreactivity

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic 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