Clinical trial NCT00273026: Study In Asthma Control
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma Advair
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 680
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of patients achieving well-controlled asthma at the end of the treatment period.
Secondary outcomes:
measure: Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Abbotsford
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Abbotsford
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Burnaby
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Chilliwack
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Delta
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Kamloops
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Maple Ridge
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Penticton
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Richmond
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Brandon
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Steinbach
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Moncton
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Rothesay
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Bay Roberts
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Holyrood
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Bridgewater
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Upper Tantallon
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Ajax
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Barrie
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Bolton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brantford
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Fort Erie
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kanata
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North York
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North York
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North York
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North York
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Prescott
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Renfrew
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: St. Catherines
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Trenton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brossard
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Charlesbourg
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Chateauguay
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Chicoutimi
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Contrecoeur
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Courcelette
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Cowansville
country: Canada
facility: GSK Investigational Site
state: Quebec
city: La Salle
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Lasalle
country: Canada
facility: GSK Investigational Site
state: Quebec
city: LeGardeur
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Princeville
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saine-Eustache
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Romuald
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte Catherine
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte Jerome
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: St-Bruno
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivières
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Ville Lasalle
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Regina
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Regina
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Québec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: