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Bronchoprotection Effect of Montelukast in Children With Persistent Allergic Rhinitis

This study is not yet open for participant recruitment.
Verified March 2012 by CHA University
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Man Yong Han, CHA University
ClinicalTrials.gov Identifier:
NCT01581710
First received: April 13, 2012
Last updated: April 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Rhinitis, Allergic, Perennial
 Drug: Montelukast to placebo
Drug: Placebo to montelukast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by CHA University:

Primary Outcome Measures:
  • dose response slope of Xrs5 [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spirometric and IOS value [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 28
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581710

Contacts
Contact: Man Yong Han, Prof 82-31-780-6262 drmesh@gmail.com

Sponsors and Collaborators
CHA University
Merck
Investigators
Principal Investigator: Man Yong Han specify Unaffiliated
  More Information

No publications provided

Responsible Party: Man Yong Han, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01581710     History of Changes
Other Study ID Numbers: CHA-121
Study First Received: April 13, 2012
Last Updated: April 19, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CHA University:
Leukotriene Antagonists
Bronchial Hyperreactivity

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013