N/A
N=4,001
Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01337336 ↗Enrolled (actual)
4,001
Serious AEs
—
Results posted
May 2011
Primary outcome: Primary: Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation — 200; 674 participants — p=0.002
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- fluticasone propionate/salmeterol xinafoate (Drug); Anticholinergics (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation |
200; 674 | 0.002 sig |
| SECONDARY Number of Participants With the Indicated COPD-related Exacerbations |
35; 168; 37; 171; 156; 448 | 0.002 sig |
| SECONDARY Mean Annual COPD-related Costs Per Participant |
1604; 1687; 934; 684; 670; 1003 | — |
| SECONDARY Number of the Indicated COPD-related Exacerbations |
0.04; 0.07; 0.06; 0.07; 0.19; 0.20 | 0.0004 sig |
Summary
The objective of this study was to examine COPD-related outcomes for patients with comorbid depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate compared to those receiving anticholinergics.
The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary disease (COPD) is estimated to be high and range from 10-40%, given that the risk of depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD. Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related healthcare utilization and costs compared to those without depression/anxiety. Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes, but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depression/anxiety. The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPD/depression-anxiety population. Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD in any field in the pre-index period and 60 days after the index date
- Diagnosis of depression/anxiety in any field and a medication for treating depression/anxiety in the pre-index period and 60 days after the index date
- Index date occurs during identification period
- Patients must be continuously eligible during 1-year pre and 1-year post-index date and be of at least 40 years of age
Exclusion Criteria
- comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis) during the 1 year pre or post-index periods
- No other maintenance medications other than the index medication on or 60 days after the index date
Data sourced from ClinicalTrials.gov (NCT01337336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.