Last updated: 11/04/2018 11:40:02

Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

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GSK study ID
SCO100250
See study documents
Clinicaltrials.gov ID
NCT00115492
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 Combination Product 250/50mcg BID with Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease
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 FDA for use in patients with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone Propionate/Salmeterol Combination Product
  • Drug: Salmeterol
    • Enrollment:
    797
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    December 2004 to June 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40 years - 0 Not applicable
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of COPD.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of COPD.
    • Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
    • History of at 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:
    • 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
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    Location
    GSK Investigational Site
    Kirkland, Washington, United States, 98034
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10016
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Illinois, United States, 62702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Riverside, California, United States, 92506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saint John, New Brunswick, Canada, E2M 3W5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Marcos, Texas, United States, 78666
    Status
    Study Complete
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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
    2007-14-06

    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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