ICS/LABA Adherence and COPD Exacerbation

AstraZeneca10,000 enrolled

Overview

The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.

This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Pulmonary Disease Chronic Obstructive

Interventions

Non-Interventional StudyOTHER

Non-Interventional Study

Eligibility

Sex: ALLMin age: 40 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * at least one prescription fill for ICS/LABA combination during identification period. * COPD diagnosis * 40 years or older at index date * \> or = 12 months of continuous health plan enrollment prior to and following index date * 1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period. Exclusion Criteria: * Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period * Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period * Patients with cancer diagnosis in 12 month pre-index period

Locations (1)

Research Facility

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

Exacerbation rate

Rate of COPD exacerbation occurring during the 12 months after therapy initiation.

Time frame: 12 months

Secondary Outcomes

Severe Exacerbation rate

Severe exacerbation rate during the 12 months after therapy initiation

Time frame: 12 months

Data from ClinicalTrials.gov

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