This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate...
Date First Received: February 1, 2005
Last Updated: May 15, 2009
Verified by: GlaxoSmithKline, May 2009
Clinical Trial Phase: Phase 4 | Start Date: November 2004
Overall Status: Completed
Estimated Enrollment: 460
Brief Summary
Official Title: “A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone”
Condition Keyword(s):
This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: fluticasone propionate/salmeterol powder
- Drug: fluticasone propionate powder
Outcome Measures for this Clinical Trial
Primary Measures
- Asthma exacerbation rate per patient per year
Secondary Measures
- Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days
Criteria for Participation in this Clinical Trial
Inclusion criteria:
- History of asthma for at least 6 months.
- Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).
Exclusion criteria:
- History of life-threatening asthma.
- Hospitalized for asthma within 3 months prior to the study.
- Current respiratory tract infection.
- Will not be able to attend clinic visits for the entire length of the study.
- Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00102765
Study ID Number: SFA103153
ClinicalTrials.gov Identifier: NCT00102765
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
