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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02446041
Other study ID # D589BR00034
Secondary ID
Status Completed
Phase N/A
First received May 13, 2015
Last updated October 10, 2016
Start date May 2015
Est. completion date October 2015

Study information

Verified date October 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 99 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Non-Interventional Study
Non-Interventional Study

Locations

Country Name City State
United States Research Facility Wilmington Delaware

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Healthcore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Time to Exacerbation Time to first COPD exacerbation during the 12 months after therapy initiation. 12 months No
Primary Exacerbation rate Rate of COPD exacerbation occurring during the 12 months after therapy initiation. 12 months No
Secondary Severe Exacerbation rate Severe exacerbation rate during the 12 months after therapy initiation 12 months No
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