Last updated: 11/04/2018 11:58:10
Study In Asthma Control
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
680
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, salmeterol
Collaborators
Not applicable
Study date(s)
November 2004 to March 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- documented clinical history of asthma and receiving regular maintenance therapy.
- Using oral/parenteral or depot corticosteroids within 12 weeks of visit 1.
- History of heavy smoking or substance abuse.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Chicoutimi, Québec, Canada, G7H 2W3
Status
Terminated/Withdrawn
Showing 1 - 6 of 132 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
2006-28-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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