GSK: Protocol Summary for SFA103081

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Protocol Summary for SFA103081

Protocol Summary
Protocol Id:	SFA103081
Secondary Ids:
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.
Phase:	phase 4
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Canada: Health Canada
Collaborators:
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.
Detailed Description:
Record Verification Date:	November 2012
Status:	Terminated
Why Study Stopped:
Study Start Date:	November 2004
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	Percentage of patients achieving well-controlled asthma at the end of the treatment period.
Secondary Outcomes:	Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.
Conditions:	Asthma
Keywords:	Asthma Advair
Eligibility Criteria:	Click to view inclusion/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.
Gender:	Both
Minimum Age:	12 Year
Maximum Age:
Enrollment:	680
Enrollment Type:
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Canada (click to view all sites in Canada) GSK Investigational Site Calgary, Alberta, T3C 3P1; Completed; GSK Investigational Site Edmonton, Alberta, T5N 2N8; Completed; GSK Investigational Site Edmonton, Alberta, T5G 3G6; Completed; GSK Investigational Site Edmonton, Alberta, T5C OA3; Completed; GSK Investigational Site Edmonton, Alberta, T5A 4L8; Completed; GSK Investigational Site Calgary, Alberta, T3E 7C4; Completed; GSK Investigational Site Burnaby, British Columbia, V5G 1T4; Completed; GSK Investigational Site Richmond, British Columbia, V7C 5L9; Completed; GSK Investigational Site Coquitlam, British Columbia, V3K 3P4; Completed; GSK Investigational Site Kamloops, British Columbia, V2C 5R9; Completed; GSK Investigational Site Coquitlam, British Columbia, V3K 3P4; Completed; GSK Investigational Site Maple Ridge, British Columbia, V2X 2L5; Completed; GSK Investigational Site Delta, British Columbia, V4K 2K5; Completed; GSK Investigational Site Penticton, British Columbia, V2A 5C8; Completed; GSK Investigational Site Vancouver, British Columbia, V5Z 4E1; Completed; GSK Investigational Site Abbotsford, British Columbia, V2S 3N8; Completed; GSK Investigational Site Chilliwack, British Columbia, V2P 4M9; Completed; GSK Investigational Site Surrey, British Columbia, V4H 2H9; Completed; GSK Investigational Site Richmond, British Columbia, V7C 5L9; Completed; GSK Investigational Site Kelowna, British Columbia, V1Y 9L8; Completed; GSK Investigational Site Coquitlam, British Columbia, V3K 3P4; Completed; GSK Investigational Site Winnipeg, Manitoba, R3C 0N2; Completed; GSK Investigational Site Brandon, Manitoba, R7A 5E7; Completed; GSK Investigational Site Winnipeg, Manitoba, R2M 5L9; Completed; GSK Investigational Site Steinbach, Manitoba, R5G 1T7; Completed; GSK Investigational Site Winnipeg, Manitoba, R3G 0W4; Completed; GSK Investigational Site Winnipeg, Manitoba, R3C 0N2; Completed; GSK Investigational Site Rothesay, New Brunswick, E2E 2R1; Completed; GSK Investigational Site Moncton, New Brunswick, E1G 1A7; Completed; GSK Investigational Site Moncton, New Brunswick, E1G 1A7; Completed; GSK Investigational Site Bay Roberts, Newfoundland and Labrador, A0G 1G0; Completed; GSK Investigational Site Saint John's, Newfoundland and Labrador, A1A 2H1; Completed; GSK Investigational Site Mount Pearl, Newfoundland and Labrador, A1N 5B6; Completed; GSK Investigational Site Saint John's, Newfoundland and Labrador, A1A 3R5; Completed; GSK Investigational Site Holyrood, Newfoundland and Labrador, A0A 2R0; Completed; GSK Investigational Site Holyrood, Newfoundland and Labrador, A0A 2R0; Completed; GSK Investigational Site Mount Pearl, Newfoundland and Labrador, A1N 2C1; Completed; GSK Investigational Site Halifax, Nova Scotia, B3H 1Y6; Completed; GSK Investigational Site Halifax, Nova Scotia, B3H 1Y6; Completed; GSK Investigational Site Bridgewater, Nova Scotia, B4V 3N2; Completed; GSK Investigational Site Upper Tantallon, Nova Scotia, B3Z 1E3; Completed; GSK Investigational Site Halifax, Nova Scotia, B3H 4M2; Completed; GSK Investigational Site Halifax, Nova Scotia, B3H 1Y6; Completed; GSK Investigational Site Scarborough, Ontario, M1B 4Z8; Completed; GSK Investigational Site London, Ontario, N6C 4Y7; Completed; GSK Investigational Site Mississauga, Ontario, L5M 2V8; Completed; GSK Investigational Site Toronto, Ontario, M4M 1J5; Completed; GSK Investigational Site Niagara Falls, Ontario, L2E 6A6; Completed; GSK Investigational Site Hamilton, Ontario, L8L 2Z5; Completed; GSK Investigational Site London, Ontario, N6B 2E8; Completed; GSK Investigational Site Richmond Hill, Ontario, L4C 3Y1; Completed; GSK Investigational Site Toronto, Ontario, M8V 3X8; Completed; GSK Investigational Site Toronto, Ontario, M5G 1E2; Completed; GSK Investigational Site Hamilton, Ontario, L8M 1K7; Completed; GSK Investigational Site North York, Ontario, M3M 3E5; Completed; GSK Investigational Site London, Ontario, N6H 4P2; Completed; GSK Investigational Site Thornhill, Ontario, L3T 4X1; Completed; GSK Investigational Site Burlington, Ontario, L7M 4Y1; Completed; GSK Investigational Site London, Ontario, N6P 1A9; Completed; GSK Investigational Site Windsor, Ontario, N8W 1E6; Completed; GSK Investigational Site Fort Erie, Ontario, L2A 1Z3; Completed; GSK Investigational Site Mississauga, Ontario, L5A 1N1; Completed; GSK Investigational Site Brampton, Ontario, L6T 4S5; Completed; GSK Investigational Site London, Ontario, N6A 4G5; Completed; GSK Investigational Site Bolton, Ontario, L7E 1E8; Completed; GSK Investigational Site Prescott, Ontario, K0E 1T0; Completed; GSK Investigational Site Renfrew, Ontario, K7V 1P6; Completed; GSK Investigational Site Mississauga, Ontario, L4Z 3J1; Completed; GSK Investigational Site North York, Ontario, M2J 1V1; Completed; GSK Investigational Site Thornhill, Ontario, L3T 4X1; Completed; GSK Investigational Site Sudbury, Ontario, P3E 3C6; Completed; GSK Investigational Site Toronto, Ontario, M4X 1W4; Completed; GSK Investigational Site Toronto, Ontario, M3J 1N2; Completed; GSK Investigational Site Newmarket, Ontario, L3Y 5G8; Completed; GSK Investigational Site Oshawa, Ontario, L1H 1B9; Completed; GSK Investigational Site Toronto, Ontario, M5B 1W8; Completed; GSK Investigational Site Toronto, Ontario, M5T 3A9; Completed; GSK Investigational Site Thornhill, Ontario, L3T 4X1; Completed; GSK Investigational Site London, Ontario, N6K 4L2; Completed; GSK Investigational Site North York, Ontario, M2M 4J5; Completed; GSK Investigational Site Niagara Falls, Ontario, L2G 1J4; Completed; GSK Investigational Site Thornhill, Ontario, L3T 4X1; Completed; GSK Investigational Site Brampton, Ontario, L6T 3J1; Completed; GSK Investigational Site Sudbury, Ontario, P3E 4M8; Completed; GSK Investigational Site Richmond Hill, Ontario, L4C 2N9; Completed; GSK Investigational Site Kitchener, Ontario, N2C 2N9; Completed; GSK Investigational Site Hamilton, Ontario, L8L 5G8; Completed; GSK Investigational Site London, Ontario, N5Y 5K7; Completed; GSK Investigational Site Oshawa, Ontario, L1G 7W4; Completed; GSK Investigational Site Burlington, Ontario, L7M 4Y1; Completed; GSK Investigational Site Barrie, Ontario, L4M 5G1; Completed; GSK Investigational Site Newmarket, Ontario, L3Y 5G8; Completed; GSK Investigational Site Kingston, Ontario, K7M 1W9; Completed; GSK Investigational Site Windsor, Ontario, N8W 5L7; Completed; GSK Investigational Site Toronto, Ontario, M9N 1X7; Completed; GSK Investigational Site Windsor, Ontario, N8X 5A6; Completed; GSK Investigational Site St. Catherines, Ontario, L2T 3Y4; Completed; GSK Investigational Site North Bay, Ontario, P1B 2H3; Completed; GSK Investigational Site Hamilton, Ontario, L8P 3A9; Completed; GSK Investigational Site Brantford, Ontario, N3R 4N3; Completed; GSK Investigational Site Toronto, Ontario, M2K 2W2; Completed; GSK Investigational Site Hamilton, Ontario, L8L 5G8; Completed; GSK Investigational Site Richmond Hill, Ontario, L4C 2N9; Completed; GSK Investigational Site Mississauga, Ontario, L5B 4A9; Completed; GSK Investigational Site Toronto, Ontario, M4V 1R2; Completed; GSK Investigational Site North York, Ontario, M2J 1W8; Completed; GSK Investigational Site London, Ontario, N6C 4Y7; Completed; GSK Investigational Site Windsor, Ontario, N8X 3V6; Completed; GSK Investigational Site Oshawa, Ontario, L1J 2K9; Completed; GSK Investigational Site Trenton, Ontario, K8V 1M2; Completed; GSK Investigational Site Kanata, Ontario, K2L 3C8; Completed; GSK Investigational Site Saine-Eustache, Québec, J7P 2V1; Completed; GSK Investigational Site Sainte-Foy, Québec, G1V 4P9; Completed; GSK Investigational Site Longueuil, Québec, J4J 2H3; Completed; GSK Investigational Site Chateauguay, Québec, J6K 3A9; Completed; GSK Investigational Site Montreal, Québec, H2L 2W5; Completed; GSK Investigational Site Courcelette, Québec, G0A 1R1; Completed; GSK Investigational Site Lasalle, Québec, H8N 1T9; Completed; GSK Investigational Site Brossard, Québec, J4Z 2K9; Completed; GSK Investigational Site Trois Rivieres, Québec, G9A 4K7; Completed; GSK Investigational Site Ville Lasalle, Québec, H8N 1X9; Completed; GSK Investigational Site Montreal, Québec, H2L 2W5; Completed; GSK Investigational Site Chicoutimi, Québec, G7H 2W3; Completed; GSK Investigational Site LeGardeur, Québec, J5Z 3C4; Completed; GSK Investigational Site Montreal, Québec, H3T 1Y6; Completed; GSK Investigational Site La Salle, Québec, H2N 1T9; Completed; GSK Investigational Site Montreal, Québec, H1K 1N4; Completed; GSK Investigational Site Montreal, Québec, H4N 2W2; Completed; GSK Investigational Site Montreal, Québec, H3S 2W1; Completed; GSK Investigational Site Sainte Jerome, Québec, J7Z 5T3; Completed; GSK Investigational Site Cowansville, Québec, J2K 2X9; Completed; GSK Investigational Site Courcelette, Québec, G0A 1R1; Completed; GSK Investigational Site Québec, Québec, G1V 4M6; Completed; GSK Investigational Site Saint Romuald, Québec, G6W 3M6; Completed; GSK Investigational Site Montreal, Québec, H2L 2W5; Completed; GSK Investigational Site Princeville, Québec, G6L 5A3; Completed; GSK Investigational Site Trois Rivières, Québec, G8T 7A1; Completed; GSK Investigational Site Montreal, Québec, H4W 1S7; Completed; GSK Investigational Site Charlesbourg, Québec, G1G 4A2; Completed; GSK Investigational Site Sainte Catherine, Québec, J0L 1E0; Completed; GSK Investigational Site Contrecoeur, Québec, J0L 1C0; Completed; GSK Investigational Site St-Bruno, Québec, G0W 2L0; Completed; GSK Investigational Site Saskatoon, Saskatchewan, S7K 7H9; Completed; GSK Investigational Site Saskatoon, Saskatchewan, S7K 3H3; Completed; GSK Investigational Site Regina, Saskatchewan, S4V 3A6; Completed; GSK Investigational Site Regina, Saskatchewan, S4V 3A6; Completed; GSK Investigational Site Regina, Saskatchewan, S4S 0A2; Completed; GSK Investigational Site Regina, Saskatchewan, S4V 3A6; Completed;

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Protocol Summary for SFA103081