ICS/LABA Adherence and COPD Exacerbation

Completed

• Conditions: Pulmonary Disease; Chronic Obstructive
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT02446041
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICS/LABA Patients	Non-Interventional Study	ICS/LABA Patients following standard of care

Primary Outcome Measures

Name	Time	Method
Exacerbation rate	12 months	Rate of COPD exacerbation occurring during the 12 months after therapy initiation.

Secondary Outcome Measures

Name	Time	Method
Severe Exacerbation rate	12 months	Severe exacerbation rate during the 12 months after therapy initiation

Trial Locations

Locations (1)

Research Facility; 🇺🇸 Wilmington, Delaware, United States