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
Study complete
Study complete
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:
Enrollment:
1
Primary completion date:
2010-25-11
Observational study model:
Cohort
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)
This study does not involve prospective enrollment of participants.
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
Study complete
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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