Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients

COPD Clinical Trial

Official title:

A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) vs. Fluticasone/Salmeterol (FSC) Combination in Patients With COPD.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921127
• Other study ID #: 000152
• Status: Completed
• Phase: N/A
• First received: August 8, 2013
• Last updated: February 2, 2016
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: RWE studies: Not applicable
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	HealthCore, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pneumonia diagnosis validation	The diagnosis codes used to identify pneumonia in the claims database will be validated through medical chart review. For the validation analysis, the validity of claims will be evaluated by finding out whether or not the patient has a diagnosis of pneumonia in the claims.	12 months	No
Primary	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	No
Secondary	COPD exacerbation rate sensitivity and subgroup analyses	The following sensitivity and subgroup analyses will be performed for the primary outcome: Time to first COPD exacerbation, on-treatment analysis, switchers and non-switchers.	12 months	No
Secondary	COPD respiratory medication use	COPD respiratory medication, use for BFC and FSC will be described in post-index period by presenting total number of COPD medication classes filled. Antibiotic use will be assessed overall and within 10 days of OCS Rx.	12 months	No
Secondary	COPD related healthcare utilization	COPD related outpatient/office visit, COPD related inpatient hospitalization length of stay, COPD related ICU admission and length of stay, COPD procedures.	12 months	No
Secondary	All-cause utilization	Frequency of all-cause resource use of: inpatient hospitalizations and length of stay, ICU admissions and length of stay, and outpatient/office visits. Total number of different prescription medication classes filled will also be determined.	12 months	No
Secondary	All- cause and COPD related healthcare costs	Costs will be reported for the following resource uses: inpatient hospitalizations, ED visits, outpatient/office visits, skilled nursing facility, total medical, and prescriptions. Costs will be reported for all-cause as well as COPD related.	12 months	No
Secondary	Treatment patterns and adherence	Continuity of care during the 12 months post-index period will be measured with the Bice and Boxerman index. Proportion of Days Covered (PDC) and Medication Possession Ratio (MPR) will be used to measure the compliance of the index-medication (Symbicort or Advair).	12 months	No
Secondary	Treatment modification	COPD medication use, such as treatment changes, will be captured post-index.	12 months	No
Secondary	COPD exacerbation rate sensitivity analysis	All COPD exacerbation rates will be captured during the entire patient follow-up (beyond 12 months of the post index period) for BFC and FSC	up to 4 years	No

External Links

•   CSR Synopsis
•   Redacted protocol