Last updated: 02/14/2020 20:40:05

Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

GSK study ID
SCO100646
See study documents
Clinicaltrials.gov ID
NCT00269126
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: See Detailed Description
Trial description: This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: fluticasone propionate/salmeterol combination DISKUS
  • Drug: salmeterol xinafoate
    • Enrollment:
    150
    Primary completion date:
    2006-16-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    February 2005 to January 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 80 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of COPD.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of COPD. Exclusion criteria:
    • Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
    • 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
    Hokkaido, Japan, 006-8555
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kyoto, Japan, 602-8026
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kyoto, Japan, 607-8062
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nara, Japan, 632-8552
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Osaka, Japan, 530-8480
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Osaka, Japan, 596-8501
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 7 Results

    Study documents

    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
    2006-16-01
    Actual study completion date
    2006-16-01

    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

    Additional information
    Not applicable
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