Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: TIO (Drug); TIO+FSC (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
This was a retrospective cohort design using administrative claims data from Jan 1, 2003
through Sep 30, 2007, representing the years of available data, were used for this study.
Managed care enrollees having at least one pharmacy claim for tiotropium (TIO) during the
study period were identified as the target population. An index TIO prescription was defined
as the first chronologically occurring pharmacy claim for TIO during the period Jan 1, 2004
to Aug 31, 2006, called the enrollment period. The date of the index TIO prescription was
termed as the index Rx date, and the 1-year period before the index Rx date was termed as
the pre-index period. The period after the index date was termed as the post-index date, and
is further divided into a 30-day combination assessment period and a 1-year follow-up
period. COPD clinical and economic outcomes were measured in a variable length follow up
period.
The combination assessment period, defined as the 30-day period following the index Rx date,
was used to categorize patients into 2 cohorts: TIO alone or TIO + FSC (fluticasone
propionate/salmeterol xinofoate combination) depending on whether they use FSC in
combination with TIO during this period. Combination therapy with TIO + FSC was defined as
having an FSC claim on the same date as the TIO claim or a TIO and FSC pharmacy claim with
overlapping days supply occurring within 30 days of index Rx date. Enrollees adding FSC for
the first time after the 30-day combination assessment period were excluded from the sample,
thus ensuring that the TIO-alone cohort is not using FSC. No outcomes were assessed in the
30-day combination assessment period. The 1-year period after the end of the 30-day
combination assessment period was termed as the follow-up period and was used to assess all
study outcomes. Enrollees were required to be continuously eligible in their health plans
during the pre-index and post-index periods for a total of 25 months. An intent-to-treat
approach was used for the analyses. Thus, patients identified to be in a drug therapy cohort
were considered to be using that therapy during the entire follow-up period, regardless of
therapy discontinuations.
Specifically the study hypothesis for the primary outcome being tested was:
Ho: There is no difference in risk of any COPD-related exacerbation between TIO+FSC and TIO
cohorts Ha: There is a difference in risk of any COPD-related exacerbation between TIO+FSC
and TIO cohorts
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between TIO+FSC and TIO cohorts Ha: There
is a difference in COPD-related costs between TIO+FSC and TIO cohorts
Clinical Details
Official title: Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Secondary outcome: Adjusted Mean Monthly Costs Per COPD Patient by Treatment GroupIncidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Continuous health plan eligibility in the pre- and post-index periods
- age ≥40 years at the index date
- Presence of at least 1 claim with an ICD-9-CM code for COPD in any diagnosis field
(490. xx, 491. xx, 492. xx, 496. xx) in the pre- and post-index period
- ≥1 exacerbation in the pre-index period (defined as a COPD-related Emergency Room
visit or hospitalization)
- ≥1 prescription claim for ipratropium or ipratropium/albuterol combination in the
pre-index period
- an index event of at least one pharmacy claim for TIO (tiotropium) combination in the
pre-index period during the study period (January 1, 2003 through April 30, 2008)
- ≥2 prescriptions for TIO (including the index prescription) during the post-index
period
Exclusion Criteria:
- presence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to
tuberculosis [TB], and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary
TB, sarcoidosis) during the pre- and post-index periods
- use of FSC in pre-index period
- exacerbation (emergency room visit or hospitalization) within 30 days after the index
date
Locations and Contacts
Additional Information
Starting date: July 2008
Last updated: September 15, 2011
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