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
Terminated (halted prematurely)
Terminated (halted prematurely)
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:
Drug: salmeterol xinafoate/fluticasone propionate
Enrollment:
680
Observational study model:
Not applicable
Primary completion date:
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Terminated/Withdrawn
Location
GSK Investigational Site
Niagara Falls, Ontario, Canada, L2E 6A6
Status
Study Complete
Location
GSK Investigational Site
Richmond, British Columbia, Canada, V7C 5L9
Status
Study Complete
Location
GSK Investigational Site
Calgary, Alberta, Canada, T3E 7C4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Abbotsford, British Columbia, Canada, V2S 6R6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 9L8
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M2K 2W2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mississauga, Ontario, Canada, L5B 3A8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E1
Status
Study Complete
Location
GSK Investigational Site
La Salle, Québec, Canada, H2N 1T9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Holyrood, Newfoundland and Labrador, Canada, A0A 2R0
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 1Y6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ville Lasalle, Québec, Canada, H8N 1X9
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Status
Study Complete
Location
GSK Investigational Site
Windsor, Ontario, Canada, N8X 5A6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
London, Ontario, Canada, N6A 4G5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Penticton, British Columbia, Canada, V2A 5C8
Status
Study Complete
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V4H 2H9
Status
Study Complete
Location
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 4M8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chilliwack, British Columbia, Canada, V2P 4M9
Status
Study Complete
Location
GSK Investigational Site
Richmond Hill, Ontario, Canada, L4C 2N9
Status
Study Complete
Location
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 5B6
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4X 1W4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 2C1
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 4M2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bridgewater, Nova Scotia, Canada, B4V 3N2
Status
Study Complete
Location
GSK Investigational Site
Saint Romuald, Québec, Canada, G6W 3M6
Status
Study Complete
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T5C OA3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Niagara Falls, Ontario, Canada, L2G 1J4
Status
Study Complete
Location
GSK Investigational Site
Upper Tantallon, Nova Scotia, Canada, B3Z 1E3
Status
Study Complete
Location
GSK Investigational Site
Sainte Jerome, Québec, Canada, J7Z 5T3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saine-Eustache, Québec, Canada, J7P 2V1
Status
Study Complete
Location
GSK Investigational Site
Richmond Hill, Ontario, Canada, L4C 3Y1
Status
Study Complete
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1A 2H1
Status
Study Complete
Location
GSK Investigational Site
St. Catherines, Ontario, Canada, L2T 3Y4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Abbotsford, British Columbia, Canada, V2S 3N8
Status
Study Complete
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T5G 3G6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Contrecoeur, Québec, Canada, J0L 1C0
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 3H3
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
Status
Study Complete
Location
GSK Investigational Site
North York, Ontario, Canada, M2M 4J5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1A 3R5
Status
Study Complete
Location
GSK Investigational Site
Delta, British Columbia, Canada, V4K 2K5
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 1T6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T3C 3P1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Longueuil, Québec, Canada, J4J 2H3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Windsor, Ontario, Canada, N8W 1E6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
London, Ontario, Canada, N6H 4P2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T5N 2N8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lasalle, Québec, Canada, H8N 1T9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Brantford, Ontario, Canada, N3R 4N3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Prescott, Ontario, Canada, K0E 1T0
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rothesay, New Brunswick, Canada, E2E 2R1
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4T 1K2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Maple Ridge, British Columbia, Canada, V2X 2L5
Status
Study Complete
Location
GSK Investigational Site
Burnaby, British Columbia, Canada, V5G 1T4
Status
Study Complete
Location
GSK Investigational Site
Kamloops, British Columbia, Canada, V2C 5R9
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 7H9
Status
Study Complete
Location
GSK Investigational Site
Sainte Catherine, Québec, Canada, J0L 1E0
Status
Study Complete
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G9A 4K7
Status
Terminated/Withdrawn
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
Terminated (halted prematurely)
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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Access to clinical trial data by researchers
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