Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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]).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cholinergic Antagonists; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

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