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:
NCT00118716
First received: July 1, 2005
Last updated: June 14, 2012
Last verified: May 2012
  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:


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.
  • Experienced worsened asthma symptoms during physical activity.
  • Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

Exclusion criteria:

  • Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
  • Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
  • Admitted to a hospital within the previous 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
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: NCT00118716

  Show 43 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00118716     History of Changes
Other Study ID Numbers: SFA100314
Study First Received: July 1, 2005
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
asthma
bronchospasm

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

ClinicalTrials.gov processed this record on October 23, 2014