Last updated: 11/07/2018 07:00:22
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg versus Anticholinergics in a Comorbid COPD-Depression/Anxiety Population
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with any chronic obstructive pulmonary disease (COPD)-related exacerbation
Timeframe: Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)
Secondary outcomes:
Number of participants with the indicated COPD-related exacerbations
Timeframe: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Mean Annual COPD-related Costs Per Participant
Timeframe: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Number of the indicated COPD-related exacerbations
Timeframe: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Interventions:
Drug: fluticasone propionate/salmeterol xinafoate
Drug: Anticholinergics
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
2010-25-11
Time perspective:
Retrospective
Clinical publications:
Dalal A, Shah M, D'Souza A, Crater G . Clinical and Economic Outcomes for Patients Initiating Fluticasone Propionate/Salmeterol Xinafoate Combination Therapy (250/50 mcg) Versus Anticholinergics in a Comorbid COPD/Depression Population . Int J Chron Obstruct Pulmon Dis. 2012;7:11-9.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
October 2010 to November 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- 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
- 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
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-25-11
Actual study completion date
2010-25-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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