Last updated: 11/04/2018 05:56:53

Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

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GSK study ID
CIL103657
See study documents
Clinicaltrials.gov ID
NCT00103922
See results summary
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, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline (BL) over 24 Wks in trough pre-bronchodilator Forced expiratory volume in 1 second (FEV1)

Timeframe: BL (Wk 0) and Wk 24

Mean change from BL over 24 Wks in total score of the St. George’s Respiratory Questionnaire (SGRQ)

Timeframe: BL (Wk 0) and Wk 24

Secondary outcomes:

Percentage of participants with Level 2 or Level 3 exacerbation-free survival at Week 24

Timeframe: Week 24

Mean change from BL in clinic trough Forced volume capacity (FVC)

Timeframe: BL (Wk 0) and endpoint assessment (upto Wk 24)

Interventions:
  • Drug: cilomilast
  • Drug: Placebo
    • Enrollment:
    612
    Primary completion date:
    2007-16-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    cilomilast
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to January 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of COPD and a history of cigarette smoking.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of COPD and a history of cigarette smoking. Exclusion criteria:
    • Significant heart or lung disease not associated with COPD.
    • Significant stomach or intestinal disease.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02135
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Aventura, Florida, United States, 33180
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tamarac, Florida, United States, 33321
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-16-01
    Actual study completion date
    2007-16-01

    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

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