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Study In Asthma Control

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
salmeterol xinafoate/fluticasone propionate
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma Advair

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

Percentage of patients achieving well-controlled asthma at the end of the treatment period.

Secondary Outcome Measures

Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.

Full Information

First Posted
January 5, 2006
Last Updated
March 19, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00273026
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
November 8, 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 28, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma Advair

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
680 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
salmeterol xinafoate/fluticasone propionate
Primary Outcome Measure Information:
Title
Percentage of patients achieving well-controlled asthma at the end of the treatment period.
Secondary Outcome Measure Information:
Title
Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3C 3P1
Country
Canada
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 7C4
Country
Canada
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5C OA3
Country
Canada
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 3G6
Country
Canada
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5N 2N8
Country
Canada
Facility Name
GSK Investigational Site
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N8
Country
Canada
Facility Name
GSK Investigational Site
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 6R6
Country
Canada
Facility Name
GSK Investigational Site
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 1T4
Country
Canada
Facility Name
GSK Investigational Site
City
Chilliwack
State/Province
British Columbia
ZIP/Postal Code
V2P 4M9
Country
Canada
Facility Name
GSK Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
GSK Investigational Site
City
Delta
State/Province
British Columbia
ZIP/Postal Code
V4K 2K5
Country
Canada
Facility Name
GSK Investigational Site
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 5R9
Country
Canada
Facility Name
GSK Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 9L8
Country
Canada
Facility Name
GSK Investigational Site
City
Maple Ridge
State/Province
British Columbia
ZIP/Postal Code
V2X 2L5
Country
Canada
Facility Name
GSK Investigational Site
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
Facility Name
GSK Investigational Site
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V7C 5L9
Country
Canada
Facility Name
GSK Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V4H 2H9
Country
Canada
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
GSK Investigational Site
City
Brandon
State/Province
Manitoba
ZIP/Postal Code
R7A 5E7
Country
Canada
Facility Name
GSK Investigational Site
City
Steinbach
State/Province
Manitoba
ZIP/Postal Code
R5G 1T7
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2M 5L9
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3G 0W4
Country
Canada
Facility Name
GSK Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
GSK Investigational Site
City
Rothesay
State/Province
New Brunswick
ZIP/Postal Code
E2E 2R1
Country
Canada
Facility Name
GSK Investigational Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0G 1G0
Country
Canada
Facility Name
GSK Investigational Site
City
Holyrood
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0A 2R0
Country
Canada
Facility Name
GSK Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 2C1
Country
Canada
Facility Name
GSK Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 5B6
Country
Canada
Facility Name
GSK Investigational Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 2H1
Country
Canada
Facility Name
GSK Investigational Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
GSK Investigational Site
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 3N2
Country
Canada
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Y6
Country
Canada
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4M2
Country
Canada
Facility Name
GSK Investigational Site
City
Upper Tantallon
State/Province
Nova Scotia
ZIP/Postal Code
B3Z 1E3
Country
Canada
Facility Name
GSK Investigational Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
GSK Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 5G1
Country
Canada
Facility Name
GSK Investigational Site
City
Bolton
State/Province
Ontario
ZIP/Postal Code
L7E 1E8
Country
Canada
Facility Name
GSK Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3T1
Country
Canada
Facility Name
GSK Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
Facility Name
GSK Investigational Site
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 4N3
Country
Canada
Facility Name
GSK Investigational Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
GSK Investigational Site
City
Fort Erie
State/Province
Ontario
ZIP/Postal Code
L2A 1Z3
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2Z5
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 3A9
Country
Canada
Facility Name
GSK Investigational Site
City
Kanata
State/Province
Ontario
ZIP/Postal Code
K2L 3C8
Country
Canada
Facility Name
GSK Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7M 1W9
Country
Canada
Facility Name
GSK Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2C 2N9
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5Y 5K7
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6B 2E8
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 4Y7
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 4P2
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6K 4L2
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6P 1A9
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Z 3J1
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 1N1
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 3A8
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 4A9
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
GSK Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
GSK Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E 6A6
Country
Canada
Facility Name
GSK Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2G 1J4
Country
Canada
Facility Name
GSK Investigational Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
GSK Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2J 1V1
Country
Canada
Facility Name
GSK Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2J 1W8
Country
Canada
Facility Name
GSK Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
GSK Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M3M 3E5
Country
Canada
Facility Name
GSK Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 7W4
Country
Canada
Facility Name
GSK Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
GSK Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K9
Country
Canada
Facility Name
GSK Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 1T6
Country
Canada
Facility Name
GSK Investigational Site
City
Prescott
State/Province
Ontario
ZIP/Postal Code
K0E 1T0
Country
Canada
Facility Name
GSK Investigational Site
City
Renfrew
State/Province
Ontario
ZIP/Postal Code
K7V 1P6
Country
Canada
Facility Name
GSK Investigational Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 2N9
Country
Canada
Facility Name
GSK Investigational Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 3Y1
Country
Canada
Facility Name
GSK Investigational Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
GSK Investigational Site
City
St. Catherines
State/Province
Ontario
ZIP/Postal Code
L2T 3Y4
Country
Canada
Facility Name
GSK Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 3C6
Country
Canada
Facility Name
GSK Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 4M8
Country
Canada
Facility Name
GSK Investigational Site
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L3T 4X1
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 2W2
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1N2
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4M 1J5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4T 1K2
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1W4
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1E2
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8V 3X8
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9N 1X7
Country
Canada
Facility Name
GSK Investigational Site
City
Trenton
State/Province
Ontario
ZIP/Postal Code
K8V 1M2
Country
Canada
Facility Name
GSK Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
GSK Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
GSK Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 3V6
Country
Canada
Facility Name
GSK Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
GSK Investigational Site
City
Brossard
State/Province
Quebec
ZIP/Postal Code
J4Z 2K9
Country
Canada
Facility Name
GSK Investigational Site
City
Charlesbourg
State/Province
Quebec
ZIP/Postal Code
G1G 4A2
Country
Canada
Facility Name
GSK Investigational Site
City
Chateauguay
State/Province
Quebec
ZIP/Postal Code
J6K 3A9
Country
Canada
Facility Name
GSK Investigational Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 2W3
Country
Canada
Facility Name
GSK Investigational Site
City
Contrecoeur
State/Province
Quebec
ZIP/Postal Code
J0L 1C0
Country
Canada
Facility Name
GSK Investigational Site
City
Courcelette
State/Province
Quebec
ZIP/Postal Code
G0A 1R1
Country
Canada
Facility Name
GSK Investigational Site
City
Cowansville
State/Province
Quebec
ZIP/Postal Code
J2K 2X9
Country
Canada
Facility Name
GSK Investigational Site
City
La Salle
State/Province
Quebec
ZIP/Postal Code
H2N 1T9
Country
Canada
Facility Name
GSK Investigational Site
City
Lasalle
State/Province
Quebec
ZIP/Postal Code
H8N 1T9
Country
Canada
Facility Name
GSK Investigational Site
City
LeGardeur
State/Province
Quebec
ZIP/Postal Code
J5Z 3C4
Country
Canada
Facility Name
GSK Investigational Site
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4J 2H3
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1K 1N4
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 2W5
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3S 2W1
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1Y6
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4W 1S7
Country
Canada
Facility Name
GSK Investigational Site
City
Princeville
State/Province
Quebec
ZIP/Postal Code
G6L 5A3
Country
Canada
Facility Name
GSK Investigational Site
City
Saine-Eustache
State/Province
Quebec
ZIP/Postal Code
J7P 2V1
Country
Canada
Facility Name
GSK Investigational Site
City
Saint Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 3M6
Country
Canada
Facility Name
GSK Investigational Site
City
Sainte Catherine
State/Province
Quebec
ZIP/Postal Code
J0L 1E0
Country
Canada
Facility Name
GSK Investigational Site
City
Sainte Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
GSK Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4P9
Country
Canada
Facility Name
GSK Investigational Site
City
St-Bruno
State/Province
Quebec
ZIP/Postal Code
G0W 2L0
Country
Canada
Facility Name
GSK Investigational Site
City
Trois Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 4K7
Country
Canada
Facility Name
GSK Investigational Site
City
Trois Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
GSK Investigational Site
City
Ville Lasalle
State/Province
Quebec
ZIP/Postal Code
H8N 1X9
Country
Canada
Facility Name
GSK Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Facility Name
GSK Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4V 3A6
Country
Canada
Facility Name
GSK Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
GSK Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 7H9
Country
Canada
Facility Name
GSK Investigational Site
City
Québec
ZIP/Postal Code
G1V 4M6
Country
Canada

12. IPD Sharing Statement

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Study In Asthma Control

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