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

NCT00127166 | Completed Phase 3 Results

• 2 other identifiers: 0476-9112004_006
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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 participants with asthma.

Conditions

Exercise Induced Asthma

Outcome Measures

Primary Outcomes (1)

• Maximum Post-exercise Percent (%) Fall in FEV1

  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 Outcomes (4)

• Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))

  4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

• Maximum FEV1 % Predicted Following First Beta-agonist Use

  4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

• Time to Recovery to Within 5% of Baseline FEV1

  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

  4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

Study Arms (2)

Montelukast/Salmeterol

EXPERIMENTAL

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; Drug: Salmeterol xinafoate; Drug: Fluticasone propionate; Drug: Montelukast matching placebo; Drug: Salmeterol matching placebo

Salmeterol/Montelukast

EXPERIMENTAL

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; Drug: Salmeterol xinafoate; Drug: Fluticasone propionate; Drug: Montelukast matching placebo; Drug: Salmeterol matching placebo

Interventions

Montelukast sodium DRUG

Montelukast 5 mg chewable tablet once daily

Montelukast/Salmeterol; Salmeterol/Montelukast

Salmeterol xinafoate DRUG

Salmeterol 50 mcg dry powder per actuation inhaled twice daily

Montelukast/Salmeterol; Salmeterol/Montelukast

Fluticasone propionate DRUG

Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily

Montelukast/Salmeterol; Salmeterol/Montelukast

Montelukast matching placebo DRUG

Matching placebo to montelukast oral tablet administered once daily.

Montelukast/Salmeterol; Salmeterol/Montelukast

Salmeterol matching placebo DRUG

Matching placebo to salmeterol dry powder for inhalation administered twice daily

Montelukast/Salmeterol; Salmeterol/Montelukast

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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. doi: 10.1016/j.anai.2009.12.011.

  PMID: 20568384 DERIVED

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

montelukast; Salmeterol Xinafoate; Fluticasone

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: August 5, 2005
• Study Start: December 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 10, 2024
• Results First Posted: December 3, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share