AsthmaPhase 4NCT00273026

Study In Asthma Control

A Phase 4 study testing salmeterol xinafoate/fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 132 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: salmeterol xinafoate/fluticasone propionate
How many people: 680 participants
Where: 132 sitesCanada
Study dates: 8 Nov 2004to 28 Mar 2006
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

documented clinical history of asthma and receiving regular maintenance therapy.

Who cannot join

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.

Trial locations and contacts

132 sites in 1 country.

City, postcode or hospital

132 sites in 1 country

Canada132 sites

GSK Investigational Site
Abbotsford British Columbia, British Columbia, V2S 3N8
GSK Investigational Site
Abbotsford British Columbia, British Columbia, V2S 6R6
GSK Investigational Site
Ajax, Ontario, L1S 2J5
GSK Investigational Site
Barrie, Ontario, L4M 5G1
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0G 1G0
GSK Investigational Site
Bolton, Ontario, L7E 1E8
GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Brampton, Ontario, L6T 4S5
GSK Investigational Site
Brandon, Manitoba, R7A 5E7
GSK Investigational Site
Brantford, Ontario, N3R 4N3
GSK Investigational Site
Bridgewater, Nova Scotia, B4V 3N2
GSK Investigational Site
Brossard, Quebec, J4Z 2K9
GSK Investigational Site
Burlington, Ontario, L7M 4Y1
GSK Investigational Site
Burnaby, British Columbia, V5G 1T4
GSK Investigational Site
Calgary, Alberta, T3C 3P1
GSK Investigational Site
Calgary, Alberta, T3E 7C4
GSK Investigational Site
Charlesbourg, Quebec, G1G 4A2
GSK Investigational Site
Châteauguay, Quebec, J6K 3A9
GSK Investigational Site
Chicoutimi, Quebec, G7H 2W3
GSK Investigational Site
Chilliwack, British Columbia, V2P 4M9
GSK Investigational Site
Contrecoeur, Quebec, J0L 1C0
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4
GSK Investigational Site
Courcelette, Quebec, G0A 1R1
GSK Investigational Site
Cowansville, Quebec, J2K 2X9
GSK Investigational Site
Delta, British Columbia, V4K 2K5
GSK Investigational Site
Edmonton, Alberta, T5A 4L8
GSK Investigational Site
Edmonton, Alberta, T5C OA3
GSK Investigational Site
Edmonton, Alberta, T5G 3G6
GSK Investigational Site
Edmonton, Alberta, T5N 2N8
GSK Investigational Site
Fort Erie, Ontario, L2A 1Z3
GSK Investigational Site
Greater Sudbury, Ontario, P3E 3C6
GSK Investigational Site
Greater Sudbury, Ontario, P3E 4M8
GSK Investigational Site
Halifax, Nova Scotia, B3H 1Y6
GSK Investigational Site
Halifax, Nova Scotia, B3H 4M2
GSK Investigational Site
Hamilton, Ontario, L8L 2Z5
GSK Investigational Site
Hamilton, Ontario, L8L 5G8
GSK Investigational Site
Hamilton, Ontario, L8M 1K7
GSK Investigational Site
Hamilton, Ontario, L8P 3A9
GSK Investigational Site
Holyrood, Newfoundland and Labrador, A0A 2R0
GSK Investigational Site
Kamloops, British Columbia, V2C 5R9
GSK Investigational Site
Kanata, Ontario, K2L 3C8
GSK Investigational Site
Kelowna, British Columbia, V1Y 9L8
GSK Investigational Site
Kingston, Ontario, K7M 1W9
GSK Investigational Site
Kitchener, Ontario, N2C 2N9
GSK Investigational Site
LaSalle, Quebec, H2N 1T9
GSK Investigational Site
LaSalle, Quebec, H8N 1T9
GSK Investigational Site
LeGardeur, Quebec, J5Z 3C4
GSK Investigational Site
London, Ontario, N5Y 5K7
GSK Investigational Site
London, Ontario, N6A 4G5
GSK Investigational Site
London, Ontario, N6B 2E8
GSK Investigational Site
London, Ontario, N6C 4Y7
GSK Investigational Site
London, Ontario, N6H 4P2
GSK Investigational Site
London, Ontario, N6K 4L2
GSK Investigational Site
London, Ontario, N6P 1A9
GSK Investigational Site
Longueuil, Quebec, J4J 2H3
GSK Investigational Site
Maple Ridge, British Columbia, V2X 2L5
GSK Investigational Site
Mississauga, Ontario, L4Z 3J1
GSK Investigational Site
Mississauga, Ontario, L5A 1N1
GSK Investigational Site
Mississauga, Ontario, L5B 3A8
GSK Investigational Site
Mississauga, Ontario, L5B 4A9
GSK Investigational Site
Mississauga, Ontario, L5M 2V8
GSK Investigational Site
Moncton, New Brunswick, E1G 1A7
GSK Investigational Site
Montreal, Quebec, H1K 1N4
GSK Investigational Site
Montreal, Quebec, H2L 2W5
GSK Investigational Site
Montreal, Quebec, H3S 2W1
GSK Investigational Site
Montreal, Quebec, H3T 1Y6
GSK Investigational Site
Montreal, Quebec, H4N 2W2
GSK Investigational Site
Montreal, Quebec, H4W 1S7
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 2C1
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 5B6
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8
GSK Investigational Site
Niagara Falls, Ontario, L2E 6A6
GSK Investigational Site
Niagara Falls, Ontario, L2G 1J4
GSK Investigational Site
North Bay, Ontario, P1B 2H3
GSK Investigational Site
North York, Ontario, M2J 1V1
GSK Investigational Site
North York, Ontario, M2J 1W8
GSK Investigational Site
North York, Ontario, M2M 4J5
GSK Investigational Site
North York, Ontario, M3M 3E5
GSK Investigational Site
Oshawa, Ontario, L1G 7W4
GSK Investigational Site
Oshawa, Ontario, L1H 1B9
GSK Investigational Site
Oshawa, Ontario, L1J 2K9
GSK Investigational Site
Penticton, British Columbia, V2A 5C8
GSK Investigational Site
Peterborough, Ontario, K9H 1T6
GSK Investigational Site
Prescott, Ontario, K0E 1T0
GSK Investigational Site
Princeville, Quebec, G6L 5A3
GSK Investigational Site
Québec, G1V 4M6
GSK Investigational Site
Regina, Saskatchewan, S4S 0A2
GSK Investigational Site
Regina, Saskatchewan, S4V 3A6
GSK Investigational Site
Renfrew, Ontario, K7V 1P6
GSK Investigational Site
Richmond, British Columbia, V7C 5L9
GSK Investigational Site
Richmond Hill, Ontario, L4C 2N9
GSK Investigational Site
Richmond Hill, Ontario, L4C 3Y1
GSK Investigational Site
Rothesay, New Brunswick, E2E 2R1
GSK Investigational Site
Saine-Eustache, Quebec, J7P 2V1
GSK Investigational Site
Saint Catherines, Ontario, L2T 3Y4
GSK Investigational Site
Saint Romuald, Quebec, G6W 3M6
GSK Investigational Site
Sainte Jerome, Quebec, J7Z 5T3
GSK Investigational Site
Sainte-Catherine, Quebec, J0L 1E0
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4P9
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 3H3
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 7H9
GSK Investigational Site
Scarborough Village, Ontario, M1B 4Z8
GSK Investigational Site
St-Bruno, Quebec, G0W 2L0
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1A 2H1
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
GSK Investigational Site
Steinbach, Manitoba, R5G 1T7
GSK Investigational Site
Surrey, British Columbia, V4H 2H9
GSK Investigational Site
Thornhill, Ontario, L3T 4X1
GSK Investigational Site
Toronto, Ontario, M2K 2W2
GSK Investigational Site
Toronto, Ontario, M3J 1N2
GSK Investigational Site
Toronto, Ontario, M4M 1J5
GSK Investigational Site
Toronto, Ontario, M4T 1K2
GSK Investigational Site
Toronto, Ontario, M4V 1R2
GSK Investigational Site
Toronto, Ontario, M4X 1W4
GSK Investigational Site
Toronto, Ontario, M5B 1W8
GSK Investigational Site
Toronto, Ontario, M5G 1E2
GSK Investigational Site
Toronto, Ontario, M5T 3A9
GSK Investigational Site
Toronto, Ontario, M8V 3X8
GSK Investigational Site
Toronto, Ontario, M9N 1X7
GSK Investigational Site
Trenton, Ontario, K8V 1M2
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1
GSK Investigational Site
Trois-Rivières, Quebec, G9A 4K7
GSK Investigational Site
Upper Tantallon, Nova Scotia, B3Z 1E3
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E1
GSK Investigational Site
Ville Lasalle, Quebec, H8N 1X9
GSK Investigational Site
Windsor, Ontario, N8W 1E6
GSK Investigational Site
Windsor, Ontario, N8W 5L7
GSK Investigational Site
Windsor, Ontario, N8X 3V6
GSK Investigational Site
Windsor, Ontario, N8X 5A6
GSK Investigational Site
Winnipeg, Manitoba, R2M 5L9
GSK Investigational Site
Winnipeg, Manitoba, R3C 0N2
GSK Investigational Site
Winnipeg, Manitoba, R3G 0W4

Other trials in Canada

About this study

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.

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
Being tested: salmeterol xinafoate/fluticasone propionate
Keywords: Asthma Advair
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

salmeterol xinafoate/fluticasone propionateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 200428 Mar 2006

First posted9 Jan 2006 (estimated)
Study start8 Nov 2004
Study completion28 Mar 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 680 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00273026
Sponsor's protocol ID: SFA103081
Status last verified: Mar 2018
First submitted: 5 Jan 2006
Last updated: 21 Mar 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00273026
Acronym / sponsor ID: SFA103081
Conditions: Asthma
Keywords: Asthma Advair
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 680 participants
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 8 Nov 2004
Study completion: 28 Mar 2006 (actual)
First posted: 9 Jan 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

documented clinical history of asthma and receiving regular maintenance therapy.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
salmeterol xinafoate/fluticasone propionate	Drug	–

Primary outcome

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

1 secondary outcome

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

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.

Related trials for Asthma

Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

132 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing salmeterol xinafoate/fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 132 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients achieving well-controlled asthma at the end of the treatment period.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00273026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.