ICS/LABA Adherence and COPD Exacerbation

Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; Chronic Obstructive
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States
      • Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICS/LABA patients with administrative claims data from health plans in the Northeast, Midwest, South and West United States.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICS/LABA Patients; ICS/LABA Patients following standard of care	Other: Non-Interventional Study; Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation rate	Rate of COPD exacerbation occurring during the 12 months after therapy initiation.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Exacerbation rate	Severe exacerbation rate during the 12 months after therapy initiation	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Exacerbation	Time to first COPD exacerbation during the 12 months after therapy initiation.	12 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: HealthCore-NERI
• Investigators: Study Chair: Frank Trudo, MD, AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Chronic Bronchitis; Pulmonary Emphysema
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: D589BR00034