Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

May 7, 2024 updated by: Organon and Co

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

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 participants with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Montelukast/Salmeterol
Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Drug: Montelukast sodium
Montelukast 5 mg chewable tablet once daily
Drug: Salmeterol xinafoate
Salmeterol 50 mcg dry powder per actuation inhaled twice daily
Drug: Fluticasone propionate
Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Drug: Montelukast matching placebo
Matching placebo to montelukast oral tablet administered once daily.
Drug: Salmeterol matching placebo
Matching placebo to salmeterol dry powder for inhalation administered twice daily
Experimental: Salmeterol/Montelukast
Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Drug: Montelukast sodium
Montelukast 5 mg chewable tablet once daily
Drug: Salmeterol xinafoate
Salmeterol 50 mcg dry powder per actuation inhaled twice daily
Drug: Fluticasone propionate
Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Drug: Montelukast matching placebo
Matching placebo to montelukast oral tablet administered once daily.
Drug: Salmeterol matching placebo
Matching placebo to salmeterol dry powder for inhalation administered twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Post-exercise Percent (%) Fall in FEV1
Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve for %-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)
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.
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Maximum FEV1 % Predicted Following First Beta-agonist Use
Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
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.
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Time to Recovery to Within 5% of Baseline FEV1
Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
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.
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
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.
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimated)

August 5, 2005

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0476-911
  • 2004_006 (Other Identifier: Merck Registration Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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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