Last updated: 11/04/2018 11:40:47

Chronic Obstructive Pulmonary Disease Endpoints Study

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GSK study ID
SCO104925
See study documents
Clinicaltrials.gov ID
NCT00358358
EudraCT ID
2005-005602-23
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 placebo-controlled study of treatments with salmeterol, fluticasone propionate and their combination to evaluate novel endpoints in patients with chronic obstructive pulmonary disease
Trial description: This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.
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 500/50mcg combination
  • Drug: Fluticasone Propionate 500mcg
  • Drug: Salmeterol 50mcg
    • Enrollment:
    163
    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)
    March 2006 to February 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of COPD
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of COPD
    • Current or ex-smoker at least 10 pack- years Exclusion criteria:
    • Diagnosis of asthma
    • Active respiratory disorder other than COPD
    • Evidence of clinically significant uncontrolled non-pulmonary disease
    • Carcinoma not in complete remission for last 5 years
    • Lung volume reduction surgery in previous 12 months
    • Nocturnal positive pressure for sleep apnea
    • Other inclusion and exclusion criteria will be evaluated at the first study visit.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Moscow, Russia, 105 229
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29615
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Moscow, Russia, 105 077
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Valparaiso, Valparaíso, Chile, 2341131
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nizhnekamsk, Russia, 423570
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barnaul, Russia, 656 045
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 11 Results

    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
    2007-13-02

    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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