Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients

NCT01921127 | Completed

• 1 other identifier: 000152
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.

Conditions

COPD

Keywords

COPD, Comparative effectiveness, Symbicort

Outcome Measures

Primary Outcomes (1)

• Rate of COPD exacerbation

  The rate of COPD exacerbation will be defined as the total number of COPD exacerbations during the post-index period for all patients in each treatment cohort divided by the total number of person years. 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 (8)

• COPD exacerbation rate sensitivity and subgroup analyses

  12 months

• COPD respiratory medication use

  12 months

• COPD related healthcare utilization

  12 months

• All-cause utilization

  12 months

• All- cause and COPD related healthcare costs

  12 months

Other Outcomes (1)

• Pneumonia diagnosis validation

  12 months

Study Arms (2)

Symbicort

BFC patients new to ICS/LABA therapies

Advair

FSC patients new to ICS/LABA 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 FSC during 3/1/2009 and 3/31/2013 who are naive to ISC/LABA combinbination therapy.

You may qualify if:

• Continuous health plan enrollment for 12 months before and after index Rx, at least one prescription for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription.

You may not qualify if:

• ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC 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 Publications (1)

• Kern DM, Davis J, Williams SA, Tunceli O, Wu B, Hollis S, Strange C, Trudo F. Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study. Respir Res. 2015 Apr 23;16(1):52. doi: 10.1186/s12931-015-0210-x.

  PMID: 25899176 DERIVED

Related Links

• Redacted protocol
• 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: August 8, 2013
• First Posted: August 13, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 3, 2016

Record last verified: 2016-02