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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381458
First received: June 23, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Drug: FSC
Drug: ACs

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Risk of Hospitalization in COPD patients [ Time Frame: January 1, 2003 through March 31, 2009 (up to 6 years) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of COPD exacerbations [ Time Frame: January 1, 2003 through March 31, 2009 (up to 6 years) ] [ Designated as safety issue: No ]
    Exacerbation rates were assessed between the FSC and AC groups. We examined COPD-related (primary dx of COPD (ICD-9 code 491.xx, 492.xx, 496.xx)) emergency department visits, outpatient visits, outpatient visits accompanied by prescription of oral steroids and antibiotics. A negative binomial regression model was run to examine this outcome.

  • COPD-related Costs [ Time Frame: January 1, 2003 through March 31, 2009 (up to 6 years) ] [ Designated as safety issue: No ]
    Mean COPD-related medical costs-, pharmacy costs - and total costs (the sum of medical and pharmacy costs) were calculated. Medical costs included healthcare facility and professional services charges for hospital admissions, ED visits, physician and other outpatient visits, and laboratory, radiology and other outpatient procedures with a primary diagnosis of COPD. Costs were adjusted to 2009 US dollars using the medical care component of the Consumer Price Index (CPI ). A Generalized Linear Model (GLM) with a log-link function was used to assess differences in costs.


Enrollment: 1936
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
fluticasone propionate / salmeterol xinofoate combination
Other Name: Advair (tm)
Drug: ACs
tiotropium alone, ipratropium alone, or in combination with albuterol

Detailed Description:

Managed care patients (aged >40 years) who were fluticasone propionate/salmeterol xinafoate combination (FSC)-naive in the 12 months pre-index period. The index-date was the date of discharge of the index Chronic Obstructive Pulmonary Disease (COPD)-related hospitalization/Emergency Department (ED) visit. Eligible patients were required to newly initiate or switch to drug therapy with FSC or ipratropium (IPR) / tiotropium (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. Patients classified as being on FSC 250/50 versus anticholinergics (TIO, IP or IPR). Examined risk of COPD-related exacerbations such as hospitalizations, emergency department (ED) visits, COPD-related physician/outpatient visit with oral corticosteroid (OCS) or antibiotic prescription (ABX) within 5 days of physician/outpatient visit and COPD-related medical, pharmacy, and total healthcare costs in follow-up period.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381458

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01381458     History of Changes
Other Study ID Numbers: 113899
Study First Received: June 23, 2011
Last Updated: June 23, 2011
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 16, 2014