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Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Asthmatic Patients
This study is ongoing, but not recruiting participants.
Sponsored by: 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

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

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percent reduction of FEV1 measured by serial spirometry measurements followed exercise challenge [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • After exercise: reduction in AUC (0-20) min of percent change in FEV1; increase in maximum predicted FEV1; time to recovery of FEV1; increase in average predicted FEV1 [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 155
Study Start Date: January 2006
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Crossover Study: Arm 1: montelukast/Pbo 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast 5mg 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 5mg 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 5mg 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 5mg chewable tablet once daily

montelukast 5mg 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
Crossover Study: Arm 2: montelukast Pbo 5mg 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 5mg chewable tablet once daily; inhaled salmeterol 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 2 weeks of treatment; montelukast 5mg 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 5mg chewable tablet once daily

montelukast 5mg 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

(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

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2004_006, MK0476-911
Study First Received: June 30, 2005
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00127166  
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Merck:
Anti Asthmatic Therapy

Study placed in the following topic categories:
Montelukast
Asthma, Exercise-Induced
Hypersensitivity
Salmeterol
Respiratory Tract Diseases
Hypersensitivity, Immediate
 Fluticasone
Asthma
Constriction, Pathologic
Leukotriene Antagonists
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on January 16, 2009



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