Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Asthmatic Patients (0476-911)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127166
First received: June 30, 2005
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Exercise Induced Asthma
Drug: montelukast sodium
Drug: Comparator: salmeterol
Drug: Comparator: fluticasone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 154
Study Start Date: December 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127166

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127166     History of Changes
Other Study ID Numbers: 0476-911, 2004_006
Study First Received: June 30, 2005
Results First Received: June 16, 2009
Last Updated: August 12, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Montelukast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Leukotriene Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on August 26, 2014