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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00273026 |
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Date of registration:
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05/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study In Asthma Control
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Scientific title:
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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. |
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Date of first enrolment:
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November 8, 2004 |
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Target sample size:
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680 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00273026 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: salmeterol xinafoate/fluticasone propionate
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Primary Outcome(s)
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Percentage of patients achieving well-controlled asthma at the end of the treatment period.
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Secondary Outcome(s)
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Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.
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Secondary ID(s)
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SFA103081
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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