This study will compare patients treated with a marketed medication and those who continue with their usual care to assess the proportion of patients achieving well controlled asthma after 24 weeks...
Date First Received: January 5, 2006
Last Updated: May 15, 2009
Verified by: GlaxoSmithKline, May 2009
Clinical Trial Phase: Phase 4 | Start Date: November 2004
Overall Status: Terminated
Estimated Enrollment: 680
Brief Summary
Official Title: “An Open-Label, Multi-Centre, Randomized, Parallel Group Clinical Effectiveness Study to Determine the Level of Asthma Control in Adolescent and Adult Patients With ADVAIR Versus Usual Care for 24 Weeks.”
Condition Keyword(s):
Intervention(s):
This study will compare patients treated with a marketed medication and those who continue with their usual care to assess the proportion of patients achieving well controlled asthma after 24 weeks.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: salmeterol xinafoate/fluticasone propionate
Outcome Measures for this Clinical Trial
Primary Measures
- Percentage of patients achieving well-controlled asthma at the end of the treatment period.
Secondary Measures
- Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- documented clinical history of asthma and receiving regular maintenance therapy.
Exclusion Criteria:
- Using oral/parenteral or depot corticosteroids within 12 weeks of visit 1.
- History of heavy smoking or substance abuse.
- Females who are pregnant or lactating.
- Required emergency room treatment for their asthma 12 weeks prior to Visit 1.
- Serious, uncontrolled, systemic disease that may make study participation unsafe or inappropriate in the opinion of the physician.
- Other medical criteria will be evaluated at the screening visit.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
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/NCT00273026
Study ID Number: SFA103081
ClinicalTrials.gov Identifier: NCT00273026
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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