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A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00118690
First received: July 1, 2005
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  Purpose

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.


Condition Intervention Phase
Bronchospasm
Activity/Exercise Induced Bronchospasm
 Drug: Fluticasone propionate/salmeterol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.

Secondary Outcome Measures:
  • Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.

Estimated Enrollment: 230
Study Start Date: December 2003
Intervention Details:
    Drug: Fluticasone propionate/salmeterol
    Other Name: Fluticasone propionate/salmeterol
  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosed with persistent asthma for 3 months or longer.
  • Experience worsened asthma symptoms during physical activity.
  • Using or used an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).

Exclusion criteria:

  • Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months.
  • Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma.
  • Admitted to a hospital within the last 6 months due to asthma symptoms.
  • Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.).
  • The study physician will evaluate other medical criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118690

  Show 42 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00118690     History of Changes
Other Study ID Numbers: SFA100316
Study First Received: July 1, 2005
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
asthma
bronchospasm

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

ClinicalTrials.gov processed this record on May 23, 2013