Last updated: 11/04/2018 11:56:48

ADVAIR® DISKUS® inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® inhaler and SEREVENT® DISKUS® inhaler are trademarks of the GSK group of companies.

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GSK study ID
SCO40043
See study documents
Clinicaltrials.gov ID
NCT00144911
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® inhaler Combination Product 250/50mcg twice daily with Salmeterol DISKUS® inhaler 50mcg twice daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Rate of moderate/severe exacerbations over a 52 week treatment period.

Timeframe: N/A

Secondary outcomes:

The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year.

Timeframe: N/A

Interventions:
  • Drug: Salmeterol
  • Drug: Fluticasone Propionate/Salmeterol Combination Product
    • Enrollment:
    740
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. (2008). Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med 102 (8); 1099-1108.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    October 2004 to November 2006
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Diagnosis of COPD (chronic obstructive pulmonary disease).
    • Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
    • Current diagnosis of asthma.
    • Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of COPD (chronic obstructive pulmonary disease).
    • Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
    • History of a least 1 COPD exacerbation in the 12 months prior to screening.
    • Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.
    Exclusion criteria:
    • Current diagnosis of asthma.
    • Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
    • Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
    • Lung resection surgery within 1 year of screening.
    • Abnormal and clinically significant ECG findings at screening.
    • Other inclusion and exclusion criteria will be evaluated at the first study visit.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Sainte-Foy, Québec, Canada, G1V 4G5
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 4J6
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    La Malbaie, Québec, Canada, G5A 1W7
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Glendale, Arizona, United States, 85306
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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