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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)

No location data available.

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
Finalized
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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