Last updated: 11/07/2018 07:00:03
Outcomes for Chronic Obstructive Pulmonary Disease moderate exacerbators initiating treatment
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Outcomes for Chronic Obstructive Pulmonary Disease moderate exacerbators initiating treatment
Trial description: 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]).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
risk of any COPD-related exacerbation
Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)
Secondary outcomes:
Moderate COPD exacerbation
Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)
COPD-related hospitalization/ED
Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)
COPD-related Costs
Timeframe: January 1, 2003 to March 31, 2009 (up to 6 years)
Interventions:
Drug: Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)
Drug: Anticholinergics (AC)
Enrollment:
2849
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Dalal AA, Shah M, D’Souza AO, Crater GD. Fluticasone propionate/salmeterol in combination delivers better outcomes versus patients with other treatments in patients with moderate exacerbations. Respiratory-Research. 2012;13(1):41.
Dalal AA, Shah M, D’Souza AO, Lunacsek OE, Nagar SP, Crater GD.Observational study of the outcomes and costs of initiating maintenance therapies in patients with moderate exacerbations of COPD.Respir Res.2012;13:41
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
March 2011 to April 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Inclusion Criteria:
- minimum age 40 years at index
Inclusion and exclusion criteria
Inclusion 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
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
Not applicable
Actual study completion date
2011-01-04
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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