ICS/LABA Adherence and COPD Exacerbation

October 10, 2016 updated by: AstraZeneca

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 12 months
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
Time Frame: 12 months
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 Frame: 12 months
Time to first COPD exacerbation during the 12 months after therapy initiation.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

HealthCore-NERI

Investigators

  • Study Chair: Frank Trudo, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D589BR00034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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