Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment
Verified date | May 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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]).
Status | Completed |
Enrollment | 2849 |
Est. completion date | June 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | risk of any COPD-related exacerbation | risk of the following types of COPD-related exacerbations between patients receiving FSC vs AC: COPD-related physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx) and/or COPD-related hospitalization or an ED visit | January 1, 2003 to March 31, 2009 (up to 6 years) | |
Secondary | Moderate COPD exacerbation | Risk of COPD-related exacerbations for patients with physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx). | January 1, 2003 to March 31, 2009 (up to 6 years) | |
Secondary | COPD-related hospitalization/ED | Risk of COPD-related exacerbations for patients with COPD hospitalization with primary diagnosis code for COPD and ED visits with the same. | January 1, 2003 to March 31, 2009 (up to 6 years) | |
Secondary | COPD-related Costs | Comparing average monthly COPD-related costs and cost components between patients receiving FSC vs AC. Medical, pharmacy and total costs were examined | January 1, 2003 to March 31, 2009 (up to 6 years) |
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