Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients
|ClinicalTrials.gov Identifier: NCT01921127|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : February 3, 2016
Information provided by (Responsible Party):
This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|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.|
|Study Start Date :||August 2013|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
BFC patients new to ICS/LABA therapies
FSC patients new to ICS/LABA therapies.
Primary Outcome Measures :
- Rate of COPD exacerbation [ Time Frame: 12 months ]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.
Secondary Outcome Measures :
- COPD exacerbation rate sensitivity and subgroup analyses [ Time Frame: 12 months ]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.
- COPD respiratory medication use [ Time Frame: 12 months ]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.
- COPD related healthcare utilization [ Time Frame: 12 months ]COPD related outpatient/office visit, COPD related inpatient hospitalization length of stay, COPD related ICU admission and length of stay, COPD procedures.
- All-cause utilization [ Time Frame: 12 months ]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.
- All- cause and COPD related healthcare costs [ Time Frame: 12 months ]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.
- Treatment patterns and adherence [ Time Frame: 12 months ]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).
- Treatment modification [ Time Frame: 12 months ]COPD medication use, such as treatment changes, will be captured post-index.
- COPD exacerbation rate sensitivity analysis [ Time Frame: up to 4 years ]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
Other Outcome Measures:
- Pneumonia diagnosis validation [ Time Frame: 12 months ]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.
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