Last updated: 11/04/2018 04:31:20

ADVAIR DISKUS® (fluticasone propionate/salmeterol) inhaler Versus SEREVENT DISKUS® (salmeterol) inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® inhalers are trademarks of the GSK group of companies.

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GSK study ID
ADC105931
See study documents
Clinicaltrials.gov ID
NCT00346749
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared with Salmeterol DISKUS 50mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Percent of sputum neutrophils

Timeframe: N/A

Secondary outcomes:

Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms

Timeframe: N/A

Interventions:
  • Drug: Salmeterol
  • Drug: Fluticasone Propionate/Salmeterol Combination Product
    • Enrollment:
    180
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    December 2006 to July 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Diagnosis of COPD.
    • Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
    • Current of secondary diagnosis of asthma or current diagnosis of atopy.
    • Other respiratory disorders other than COPD.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of COPD.
    • Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
    • Ex-Smokers with at least a 10 pack-year history.
    Exclusion criteria:
    • Current of secondary diagnosis of asthma or current diagnosis of atopy.
    • Other respiratory disorders other than COPD.
    • Other inflammatory diseases.
    • Abnormal and clinically significant chest x-ray or ECG.
    • Lung resection surgery within past 1 year.
    • History of cancer not in remission within past 2 years.
    • Serious, uncontrolled disease.
    • Pregnancy or planning to become pregnant during the study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27704
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19140
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fort Collins, Colorado, United States, 80528
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53792
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30030
    Status
    Terminated/Withdrawn
    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
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-24-07

    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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