Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients

This study has been completed.
Sponsor:
Collaborator:
HealthCore, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01921127
First received: August 8, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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


Condition
COPD

Study Type: Observational
Study Design: 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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Rate of COPD exacerbation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    COPD medication use, such as treatment changes, will be captured post-index.

  • COPD exacerbation rate sensitivity analysis [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 3000
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Symbicort
BFC patients new to ICS/LABA therapies
Advair
FSC patients new to ICS/LABA therapies.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01921127     History of Changes
Other Study ID Numbers: 000152
Study First Received: August 8, 2013
Last Updated: May 14, 2014
Health Authority: RWE studies: Not applicable

Keywords provided by AstraZeneca:
COPD, Comparative effectiveness, Symbicort

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Symbicort
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014