Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

NCT01917643 | Completed

• 1 other identifier: 000202
• Study Type: observational
• Target: 2,396
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.

Conditions

COPD Exacerbation

Keywords

COPD, Comparative Effectiveness, Symbicort

Outcome Measures

Primary Outcomes (1)

• Time to first COPD exacerbation

  The time to first COPD exacerbation will be calculated as the date of first COPD exacerbation minus index date. A COPD exacerbation event is defined as any of three conditions: COPD related inpatient hospitalization, COPD related emergency department visit, or COPD outpatient/office visit with a pharmacy claim for OCS and/or antibiotics on the same day or within ten days.

  12 months

Secondary Outcomes (7)

• COPD exacerbation rates

  12 months

• COPD respiratory medication use

  12 months

• COPD related utilization

  12 months

• All-cause utilization

  12 months

• All-cause and COPD related healthcare costs

  12 months

Study Arms (2)

Symbicort

BFC patients new to ICS/LABA and LAMA therapies

Spiriva

Tiotropium bromide patients new to ICS/LABA and LAMA therapies

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Health plan members with COPD aged 40 years or older receiving one or more prescriptions of BFC or tiotropium bromide during 3/1/2009 and 1/31/2012 who are naive to ICS/LABA and LAMA combination therapies.

You may qualify if:

• Continuous health plan enrollment for 12 months before and after index Rx
• At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
• COPD diagnosis, and aged 40 years of age at time of first prescription
• At risk population for COPD exacerbations

You may not qualify if:

• ICS/LABA combination or LAMA therapy during pre-index period
• Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day
• Patients diagnosed with cancer
• Patients with long-term OCS medication use during pre-index period

Sponsors & Collaborators

• AstraZeneca: lead
• HealthCore, Inc.: collaborator

Related Links

• Redacted protocol of Study 000202
• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 7, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 3, 2016

Record last verified: 2016-02