Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment
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: Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC) (Drug); Anticholinergics (AC) (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of
all diagnosed COPD patients. Yet limited data exists on characterizing this study population
in terms of drug therapy patterns and COPD-related resource use and costs. The objective of
the following study was to conduct an analysis in the real-world setting to (1) identify and
characterize COPD patients with moderate exacerbations and (2) evaluate the impact of
initiating different maintenance therapies in this population. Maintenance therapy
medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs),
combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and
ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium
[IPR]).
Clinical Details
Official title: Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: risk of any COPD-related exacerbation
Secondary outcome: Moderate COPD exacerbationCOPD-related hospitalization/ED COPD-related Costs
Detailed description:
Data from January 1, 2003 to March 31, 2009 will be available and termed as the study
period. Patients with at least one moderate exacerbation defined as a physician/outpatient
visit with a primary diagnosis of COPD and having an oral corticosteroid (OCS) or antibiotic
prescription (ABX) within 5 days of physician/outpatient visit will be identified as the
target population. The date of the first moderate exacerbation will serve as the patient's
index date, and will be identified during the identification period of January 1, 2004
through February 28, 2009. Furthermore this moderate exacerbation should be the first
medical claim with a primary diagnosis of COPD to ensure that only patients with moderate
exacerbations will be captured. Subsequently, patients will be categorized into study
cohorts based on the first maintenance drug prescription (index drug) received during the
30-day period after the index date termed as the treatment assessment period. Maintenance
drugs considered include fluticasone-salmeterol 250/50 mcg (FSC) or anticholinergics (AC)
including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol
(collectively referred to as ipratropium [IPR]). Patients not receiving any maintenance
medication or those receiving maintenance medications other than those considered during the
treatment assessment period will be excluded.
All outcomes will be assessed during a follow-up period that will vary in length between 1
day and 1 year for each patient. The variable follow-up period will be defined as the period
that starts on the day after the treatment assessment period, and ends on the earliest of
the following event dates: the end of the study period (March 31, 2009), the end of the
patient's continuous eligibility in the health plan, the end of the patient's 1-year
follow-up, treatment switch date (ie, a switch to any study medication different from the
index drug), discontinuation date of the index drug (ie, more than a 60-day gap between the
end of the days' supply of the preceding prescription and the fill date of the next
consecutive prescription), or occurrence of any COPD-related exacerbation (COPD-related
hospitalization, ED visit, or physician/outpatient visit with a prescription for an oral
corticosteroid or antibiotic within 5 days of the visit).
A 1-year period before the index date (pre-period) will be used to provide a baseline
assessment of the study cohorts. The specific dates for the pre- and follow-up periods will
vary for each patient depending on their index date.
Specifically the study hypothesis for the primary outcome being tested was:
Ho: There is no difference in risk of any COPD-related exacerbation between FSC and AC
cohorts Ha: There is a difference in risk of any COPD-related exacerbation between FSC and
AC 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 FSC and AC cohorts Ha: There is a
difference in COPD-related costs between FSC and AC cohorts
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- minimum age 40 years at index
- continuously enrolled in health plan
- diagnosis of COPD (ICD-9 codes of 491, 492, 496)
- at least one moderate exacerbation event as defined previously.
Exclusion Criteria
- Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due
to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary
TB, or sarcoidosis
- Patients excluded if they did not receive treatment within the treatment assessment
period following moderate exacerbation
- Receipt of maintenance medication in the pre-period
- Presence of treatment switch, discontinuation of index drug, or any COPD-related
exacerbation during the treatment assessment period
Locations and Contacts
Additional Information
Starting date: March 2011
Last updated: July 14, 2011
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