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

NCT01381458 | Completed

• 1 other identifier: 113899
• Study Type: observational
• Target: 1,936
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Risk of Hospitalization in COPD patients

  Risk of hospitalization was assessed as any hospitalization that was catpured in the follow up period. We required this event to have a primary discharge dx of COPD (ICD-9 code 491.xx, 492.xx, 496.xx) thus assuring it to be COPD-related. a logistic regression model was run to examine this outcome.

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

Secondary Outcomes (2)

• Number of COPD exacerbations

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

• COPD-related Costs

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

Study Arms (1)

COPD patients receiving pharmacotherapy

COPD patients age 40 years and older receiving pharmacotherapy to treat their COPD and an index event of COPD hospitalization or ER visit.

Drug: FSC; Drug: ACs

Interventions

FSC DRUG

fluticasone propionate / salmeterol xinofoate combination

Also known as: Advair (tm)

COPD patients receiving pharmacotherapy

ACs DRUG

tiotropium alone, ipratropium alone, or in combination with albuterol

COPD patients receiving pharmacotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Managed care patients (aged \>40 years) who were FSC naive in the 12 months pre-index period. The index-date was the date of discharge of the index COPD-related hospitalization/ED visit. Eligible patients were required to newly initiate or switch to drug therapy with FSC or IPR/TIO during the identification period (01/01/2004 to 01/31/2008) to treat COPD. Patients who switched to another maintenance medication or had an exacerbation in the treatment assessment period (30-days post-index date) were excluded from the study. Follow-up period was 12 months post treatment assessment period.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 22, 2017

Record last verified: 2017-05