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NCT00273026 Clinical Trial

Study In Asthma Control

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00273026
Other study ID # SFA103081
Secondary ID
Status Terminated
Phase Phase 4
First received January 5, 2006
Last updated March 19, 2018
Start date November 8, 2004
Est. completion date March 28, 2006

Study information
Verified date March 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 680
Est. completion date March 28, 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• salmeterol xinafoate/fluticasone propionate

Locations
Country Name City State
Canada GSK Investigational Site Abbotsford British Columbia
Canada GSK Investigational Site Abbotsford British Columbia
Canada GSK Investigational Site Ajax Ontario
Canada GSK Investigational Site Barrie Ontario
Canada GSK Investigational Site Bay Roberts Newfoundland and Labrador
Canada GSK Investigational Site Bolton Ontario
Canada GSK Investigational Site Brampton Ontario
Canada GSK Investigational Site Brampton Ontario
Canada GSK Investigational Site Brandon Manitoba
Canada GSK Investigational Site Brantford Ontario
Canada GSK Investigational Site Bridgewater Nova Scotia
Canada GSK Investigational Site Brossard Quebec
Canada GSK Investigational Site Burlington Ontario
Canada GSK Investigational Site Burnaby British Columbia
Canada GSK Investigational Site Calgary Alberta
Canada GSK Investigational Site Calgary Alberta
Canada GSK Investigational Site Charlesbourg Quebec
Canada GSK Investigational Site Chateauguay Quebec
Canada GSK Investigational Site Chicoutimi Quebec
Canada GSK Investigational Site Chilliwack British Columbia
Canada GSK Investigational Site Contrecoeur Quebec
Canada GSK Investigational Site Coquitlam British Columbia
Canada GSK Investigational Site Courcelette Quebec
Canada GSK Investigational Site Cowansville Quebec
Canada GSK Investigational Site Delta British Columbia
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Fort Erie Ontario
Canada GSK Investigational Site Halifax Nova Scotia
Canada GSK Investigational Site Halifax Nova Scotia
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site Holyrood Newfoundland and Labrador
Canada GSK Investigational Site Kamloops British Columbia
Canada GSK Investigational Site Kanata Ontario
Canada GSK Investigational Site Kelowna British Columbia
Canada GSK Investigational Site Kingston Ontario
Canada GSK Investigational Site Kitchener Ontario
Canada GSK Investigational Site La Salle Quebec
Canada GSK Investigational Site Lasalle Quebec
Canada GSK Investigational Site LeGardeur Quebec
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site Longueuil Quebec
Canada GSK Investigational Site Maple Ridge British Columbia
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Moncton New Brunswick
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Mount Pearl Newfoundland and Labrador
Canada GSK Investigational Site Mount Pearl Newfoundland and Labrador
Canada GSK Investigational Site Newmarket Ontario
Canada GSK Investigational Site Niagara Falls Ontario
Canada GSK Investigational Site Niagara Falls Ontario
Canada GSK Investigational Site North Bay Ontario
Canada GSK Investigational Site North York Ontario
Canada GSK Investigational Site North York Ontario
Canada GSK Investigational Site North York Ontario
Canada GSK Investigational Site North York Ontario
Canada GSK Investigational Site Oshawa Ontario
Canada GSK Investigational Site Oshawa Ontario
Canada GSK Investigational Site Oshawa Ontario
Canada GSK Investigational Site Penticton British Columbia
Canada GSK Investigational Site Peterborough Ontario
Canada GSK Investigational Site Prescott Ontario
Canada GSK Investigational Site Princeville Quebec
Canada GSK Investigational Site Québec
Canada GSK Investigational Site Regina Saskatchewan
Canada GSK Investigational Site Regina Saskatchewan
Canada GSK Investigational Site Renfrew Ontario
Canada GSK Investigational Site Richmond British Columbia
Canada GSK Investigational Site Richmond Hill Ontario
Canada GSK Investigational Site Richmond Hill Ontario
Canada GSK Investigational Site Rothesay New Brunswick
Canada GSK Investigational Site Saine-Eustache Quebec
Canada GSK Investigational Site Saint John's Newfoundland and Labrador
Canada GSK Investigational Site Saint John's Newfoundland and Labrador
Canada GSK Investigational Site Saint Romuald Quebec
Canada GSK Investigational Site Sainte Catherine Quebec
Canada GSK Investigational Site Sainte Jerome Quebec
Canada GSK Investigational Site Sainte-Foy Quebec
Canada GSK Investigational Site Saskatoon Saskatchewan
Canada GSK Investigational Site Saskatoon Saskatchewan
Canada GSK Investigational Site Scarborough Ontario
Canada GSK Investigational Site St-Bruno Quebec
Canada GSK Investigational Site St. Catherines Ontario
Canada GSK Investigational Site Steinbach Manitoba
Canada GSK Investigational Site Sudbury Ontario
Canada GSK Investigational Site Sudbury Ontario
Canada GSK Investigational Site Surrey British Columbia
Canada GSK Investigational Site Thornhill Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Trenton Ontario
Canada GSK Investigational Site Trois Rivieres Quebec
Canada GSK Investigational Site Trois Rivières Quebec
Canada GSK Investigational Site Upper Tantallon Nova Scotia
Canada GSK Investigational Site Vancouver British Columbia
Canada GSK Investigational Site Ville Lasalle Quebec
Canada GSK Investigational Site Windsor Ontario
Canada GSK Investigational Site Windsor Ontario
Canada GSK Investigational Site Windsor Ontario
Canada GSK Investigational Site Windsor Ontario
Canada GSK Investigational Site Winnipeg Manitoba
Canada GSK Investigational Site Winnipeg Manitoba
Canada GSK Investigational Site Winnipeg Manitoba

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients achieving well-controlled asthma at the end of the treatment period.
Secondary 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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