ICS/LABA Adherence and COPD Exacerbation

NCT ID: NCT02446041

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Disease Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ICS/LABA Patients

ICS/LABA Patients following standard of care

Non-Interventional Study

Intervention Type OTHER

Non-Interventional Study

Interventions

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Non-Interventional Study

Non-Interventional Study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carelon Research

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Trudo, MD

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Facility

Wilmington, Delaware, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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D589BR00034

Identifier Type: -

Identifier Source: org_study_id

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