Study In Asthma Control

NCT00273026 | Terminated Phase 4

• 1 other identifier: SFA103081
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 132

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.

Conditions

Asthma

Keywords

Asthma Advair

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

salmeterol xinafoate/fluticasone propionate DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• documented clinical history of asthma and receiving regular maintenance therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (132)

GSK Investigational Site

Calgary, Alberta, T3C 3P1, Canada

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GSK Investigational Site

Calgary, Alberta, T3E 7C4, Canada

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Edmonton, Alberta, T5A 4L8, Canada

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Edmonton, Alberta, T5C OA3, Canada

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Edmonton, Alberta, T5G 3G6, Canada

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Edmonton, Alberta, T5N 2N8, Canada

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Abbotsford, British Columbia, V2S 3N8, Canada

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Abbotsford, British Columbia, V2S 6R6, Canada

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Burnaby, British Columbia, V5G 1T4, Canada

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Chilliwack, British Columbia, V2P 4M9, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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Delta, British Columbia, V4K 2K5, Canada

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Kamloops, British Columbia, V2C 5R9, Canada

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Kelowna, British Columbia, V1Y 9L8, Canada

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Maple Ridge, British Columbia, V2X 2L5, Canada

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Penticton, British Columbia, V2A 5C8, Canada

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Richmond, British Columbia, V7C 5L9, Canada

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Surrey, British Columbia, V4H 2H9, Canada

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Vancouver, British Columbia, V5Z 4E1, Canada

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Brandon, Manitoba, R7A 5E7, Canada

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Steinbach, Manitoba, R5G 1T7, Canada

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Winnipeg, Manitoba, R2M 5L9, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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Winnipeg, Manitoba, R3G 0W4, Canada

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Moncton, New Brunswick, E1G 1A7, Canada

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Rothesay, New Brunswick, E2E 2R1, Canada

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Bay Roberts, Newfoundland and Labrador, A0G 1G0, Canada

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Holyrood, Newfoundland and Labrador, A0A 2R0, Canada

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Mount Pearl, Newfoundland and Labrador, A1N 2C1, Canada

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Mount Pearl, Newfoundland and Labrador, A1N 5B6, Canada

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St. John's, Newfoundland and Labrador, A1A 2H1, Canada

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St. John's, Newfoundland and Labrador, A1A 3R5, Canada

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Bridgewater, Nova Scotia, B4V 3N2, Canada

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Halifax, Nova Scotia, B3H 1Y6, Canada

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Halifax, Nova Scotia, B3H 4M2, Canada

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Upper Tantallon, Nova Scotia, B3Z 1E3, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Barrie, Ontario, L4M 5G1, Canada

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Bolton, Ontario, L7E 1E8, Canada

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Brampton, Ontario, L6T 3T1, Canada

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Brampton, Ontario, L6T 4S5, Canada

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Brantford, Ontario, N3R 4N3, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Fort Erie, Ontario, L2A 1Z3, Canada

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Greater Sudbury, Ontario, P3E 3C6, Canada

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Greater Sudbury, Ontario, P3E 4M8, Canada

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Hamilton, Ontario, L8L 2Z5, Canada

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Hamilton, Ontario, L8L 5G8, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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Hamilton, Ontario, L8P 3A9, Canada

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Kanata, Ontario, K2L 3C8, Canada

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Kingston, Ontario, K7M 1W9, Canada

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Kitchener, Ontario, N2C 2N9, Canada

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London, Ontario, N5Y 5K7, Canada

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London, Ontario, N6A 4G5, Canada

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London, Ontario, N6B 2E8, Canada

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London, Ontario, N6C 4Y7, Canada

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London, Ontario, N6H 4P2, Canada

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London, Ontario, N6K 4L2, Canada

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London, Ontario, N6P 1A9, Canada

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Mississauga, Ontario, L4Z 3J1, Canada

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Mississauga, Ontario, L5A 1N1, Canada

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Mississauga, Ontario, L5B 3A8, Canada

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Mississauga, Ontario, L5B 4A9, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Niagara Falls, Ontario, L2E 6A6, Canada

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Niagara Falls, Ontario, L2G 1J4, Canada

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North Bay, Ontario, P1B 2H3, Canada

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North York, Ontario, M2J 1V1, Canada

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North York, Ontario, M2J 1W8, Canada

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North York, Ontario, M2M 4J5, Canada

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North York, Ontario, M3M 3E5, Canada

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Oshawa, Ontario, L1G 7W4, Canada

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Oshawa, Ontario, L1H 1B9, Canada

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Oshawa, Ontario, L1J 2K9, Canada

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Peterborough, Ontario, K9H 1T6, Canada

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Prescott, Ontario, K0E 1T0, Canada

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Renfrew, Ontario, K7V 1P6, Canada

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Richmond Hill, Ontario, L4C 2N9, Canada

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Richmond Hill, Ontario, L4C 3Y1, Canada

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Saint Catherines, Ontario, L2T 3Y4, Canada

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Scarborough Village, Ontario, M1B 4Z8, Canada

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Thornhill, Ontario, L3T 4X1, Canada

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Toronto, Ontario, M2K 2W2, Canada

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Toronto, Ontario, M3J 1N2, Canada

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Toronto, Ontario, M4M 1J5, Canada

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Toronto, Ontario, M4T 1K2, Canada

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Toronto, Ontario, M4V 1R2, Canada

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Toronto, Ontario, M4X 1W4, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 1E2, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Toronto, Ontario, M8V 3X8, Canada

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Toronto, Ontario, M9N 1X7, Canada

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Trenton, Ontario, K8V 1M2, Canada

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Windsor, Ontario, N8W 1E6, Canada

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Windsor, Ontario, N8W 5L7, Canada

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Windsor, Ontario, N8X 3V6, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Brossard, Quebec, J4Z 2K9, Canada

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Charlesbourg, Quebec, G1G 4A2, Canada

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Châteauguay, Quebec, J6K 3A9, Canada

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Chicoutimi, Quebec, G7H 2W3, Canada

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Contrecoeur, Quebec, J0L 1C0, Canada

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Courcelette, Quebec, G0A 1R1, Canada

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Cowansville, Quebec, J2K 2X9, Canada

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LaSalle, Quebec, H2N 1T9, Canada

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LaSalle, Quebec, H8N 1T9, Canada

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LeGardeur, Quebec, J5Z 3C4, Canada

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Longueuil, Quebec, J4J 2H3, Canada

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Montreal, Quebec, H1K 1N4, Canada

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Montreal, Quebec, H2L 2W5, Canada

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Montreal, Quebec, H3S 2W1, Canada

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Montreal, Quebec, H3T 1Y6, Canada

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Montreal, Quebec, H4N 2W2, Canada

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Montreal, Quebec, H4W 1S7, Canada

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Princeville, Quebec, G6L 5A3, Canada

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Saine-Eustache, Quebec, J7P 2V1, Canada

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Saint Romuald, Quebec, G6W 3M6, Canada

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Sainte Jerome, Quebec, J7Z 5T3, Canada

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Sainte-Catherine, Quebec, J0L 1E0, Canada

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Sainte-Foy, Quebec, G1V 4P9, Canada

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St-Bruno, Quebec, G0W 2L0, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G9A 4K7, Canada

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Ville Lasalle, Quebec, H8N 1X9, Canada

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GSK Investigational Site

Regina, Saskatchewan, S4S 0A2, Canada

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Regina, Saskatchewan, S4V 3A6, Canada

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Saskatoon, Saskatchewan, S7K 3H3, Canada

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GSK Investigational Site

Saskatoon, Saskatchewan, S7K 7H9, Canada

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GSK Investigational Site

Québec, G1V 4M6, Canada

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MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: November 8, 2004
• Study Completion: March 28, 2006
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

CA (132)