Last updated: 11/07/2018 07:00:03

Outcomes for Chronic Obstructive Pulmonary Disease moderate exacerbators initiating treatment

GSK study ID
113901
See study documents
Clinicaltrials.gov ID
NCT01395875
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: Outcomes for Chronic Obstructive Pulmonary Disease moderate exacerbators initiating treatment
Trial description: Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. The objective of the following study was to conduct an analysis in the real-world setting to (1) identify and characterize COPD patients with moderate exacerbations and (2) evaluate the impact of initiating different maintenance therapies in this population. Maintenance therapy medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

risk of any COPD-related exacerbation

Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)

Secondary outcomes:

Moderate COPD exacerbation

Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)

COPD-related hospitalization/ED

Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)

COPD-related Costs

Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)

Interventions:
  • Drug: Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)
  • Drug: Anticholinergics (AC)
    • Enrollment:
    2849
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Dalal AA, Shah M, D’Souza AO, Crater GD. Fluticasone propionate/salmeterol in combination delivers better outcomes versus patients with other treatments in patients with moderate exacerbations. Respiratory-Research. 2012;13(1):41.
    Dalal AA, Shah M, D’Souza AO, Lunacsek OE, Nagar SP, Crater GD.Observational study of the outcomes and costs of initiating maintenance therapies in patients with moderate exacerbations of COPD.Respir Res.2012;13:41
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    March 2011 to April 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • minimum age 40 years at index
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • minimum age 40 years at index
    • continuously enrolled in health plan
    • diagnosis of COPD (ICD-9 codes of 491, 492, 496)
    • at least one moderate exacerbation event as defined previously. Exclusion Criteria
    • Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis
    • Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation
    • Receipt of maintenance medication in the pre-period
    • Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2011-01-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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