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

NCT01381458 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1936

Last updated 2017-05-22

No results posted yet for this study

Summary

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

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

FSC

fluticasone propionate / salmeterol xinofoate combination

DRUG

ACs

tiotropium alone, ipratropium alone, or in combination with albuterol

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-10-31
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01381458 on ClinicalTrials.gov