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OpenTrials
Completed

NCT Number: NCT01921127

Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • HealthCore, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2013
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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