Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Asthmatic Patients

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00127166

First received: June 30, 2005

Last updated: April 7, 2010

Last verified: April 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

April 7, 2010

Start Date ^ICMJE

December 2005

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Post-exercise Percent Fall in FEV1 [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]

The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on exercise-induced bronchoconstriction (EIB) as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in forced expiratory volume in one second (FEV1).

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00127166 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Area Under the Curve for Percent-change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20)) [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.
Maximum FEV1 Percent Predicted Following First Beta-agonist Use [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.
Time to Recovery to Within 5 Percent of Baseline FEV1 [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.
Average (Avg) Percent (%) Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second Beta-agonist Use [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Asthmatic Patients

Official Title ^ICMJE

A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years

Brief Summary

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in asthmatic patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Exercise Induced Asthma

Intervention ^ICMJE

Drug: montelukast sodium
montelukast/Pbo 5 mg chewable tablet once daily

montelukast 5 mg chewable tablet once daily
Drug: Comparator: salmeterol
inhaled salmeterol Pbo 100 ug (2 puffs), twice daily

inhaled salmeterol 100 ug (2 puffs), twice daily
Drug: Comparator: fluticasone
inhaled fluticasone 200 ug/day

Study Arm (s)

Experimental: 1
Crossover Study: Arm 1: montelukast/placebo (Pbo) 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 2 weeks of treatment; montelukast Pbo 5 mg chewable tablet once daily; inhaled salmeterol 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment.
Interventions:
- Drug: montelukast sodium
- Drug: Comparator: salmeterol
- Drug: Comparator: fluticasone
Experimental: 2
Crossover Study: Arm 2: montelukast Pbo 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5 mg chewable tablet once daily; inhaled salmeterol 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 2 weeks of treatment; montelukast 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment.
Interventions:
- Drug: montelukast sodium
- Drug: Comparator: salmeterol
- Drug: Comparator: fluticasone

Publications *

Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

154

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

6-14 year old children with a history of asthma for at least 12 months
Patients must demonstrate airway constriction brought on by exercise

Exclusion Criteria:

Patient is taking any medications that are not allowed in the study

Gender

Both

Ages

6 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00127166

Other Study ID Numbers ^ICMJE

2004_006, MK0476-911

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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