Last updated: 11/07/2018 06:59:44

Risk of Re-Hospitalization in Patients with Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation

GSK study ID
113899
See study documents
Clinicaltrials.gov ID
NCT01381458
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: Differences in the risk of re-hospitalization and other COPD-related (Chronic Obstructive Pulmonary Disease) exacerbations and costs for patients receiving fluticasone propionate-salmeterol xinafoate combination 250/50mcg (FSC) versus anticholinergics [i.e. tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (IPR) post-hospitalization or ED visit for the treatment of COPD.
Trial description: This retrospective database study will assess differences in the risk of re-hospitalization and other COPD-related exacerbations and costs for patients receiving fluticasone propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i.e. tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the treatment of COPD.
This is a hypotheses testing study. Associations are compared between FSC and AC cohorts.
Hypotheses for the primary outcome and key secondary outcomes are presented below:
Specifically the study hypotheses for the primary outcome being tested were:
Ho: There is no difference in risk of COPD-related hospitalization between FSC and AC
Ha: There is a difference in risk of COPD-related hospitalization between FSC and AC
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between FSC and AC
Ha: There is a difference in COPD-related costs between FSC and AC
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Risk of Hospitalization in COPD patients

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

Secondary outcomes:

Number of COPD exacerbations

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

COPD-related Costs

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

Interventions:
  • Drug: FSC
  • Drug: ACs
    • Enrollment:
    1936
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Dalal AA, Shah M, D’Souza, Crater GD .Reshospitalization Risks and outcomes in COPD Patients Receiving Maintenance Pharmacotherapy.Respir Med.2012;106(6):829-837.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to October 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    None
    • ≥40 years of age at index discharge date
    • Continuous health plan eligibility in the pre-index, treatment assessment, and follow-up periods
    • COPD-related exacerbation during the treatment assessment period
    • Any therapy change, which was defined as switching or augmenting index therapy during treatment assessment period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • ≥40 years of age at index discharge date
    • Continuous health plan eligibility in the pre-index, treatment assessment, and follow-up periods
    • Absence of other fluticasone propionate -salmeterol xinafoate doses or combination product of budesonide-formoterol anytime during pre-index, treatment assessment, and follow-up periods
    Exclusion criteria:
    • COPD-related exacerbation during the treatment assessment period
    • Any therapy change, which was defined as switching or augmenting index therapy during treatment assessment period
    • Absence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, and sarcoidosis) during the pre-index, treatment assessment, and follow-up periods

    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
    2010-08-10

    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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