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Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01921127
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : February 3, 2016
HealthCore, Inc.
Information provided by (Responsible Party):

Brief Summary:
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

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

BFC patients new to ICS/LABA therapies
FSC patients new to ICS/LABA therapies.

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. Treatment modification [ Time Frame: 12 months ]
    COPD medication use, such as treatment changes, will be captured post-index.

  8. 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:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT01921127    
Other Study ID Numbers: 000152
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by AstraZeneca:
COPD, Comparative effectiveness, Symbicort