ICS/LABA Adherence and COPD Exacerbation

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446041
• Other study ID #: D589BR00034
• 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

• Chronic Obstructive
• Lung Diseases
• Pulmonary Disease

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

External Links

•   CSR Synopsis