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Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Asthmatic Patients
This study has been completed.
First Received: June 30, 2005   Last Updated: January 21, 2010   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00127166
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Asthma Exercise and Physical Fitness
Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Montelukast sodium Montelukast
U.S. FDA Resources

Further study details as provided by Merck:

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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
PhRMA Clinical Study Results Database - web-based repository for clinical study results  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2004_006, MK0476-911
Study First Received: June 30, 2005
Results First Received: June 16, 2009
Last Updated: January 21, 2010
ClinicalTrials.gov Identifier: NCT00127166     History of Changes
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on February 08, 2010



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