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Completed

NCT Number: NCT01917643

Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.

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Key information

Conditions

COPD Exacerbation Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.

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 fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
  • COPD diagnosis, and aged 40 years of age at time of first prescription
  • At risk population for COPD exacerbations

Exclusion criteria

  • ICS/LABA combination or LAMA therapy during pre-index period
  • Patients with prescription claim for budesonide/formoterol and tiotropium bromide 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. Time to first COPD exacerbation

    Time frame: 12 months

    The time to first COPD exacerbation will be calculated as the date of first COPD exacerbation minus index date. 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 rates

    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.

  2. COPD respiratory medication use

    Time frame: 12 months

  3. COPD related 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 month post-index period will be measured with the Bice and Boxerman index. Proportion of Days Covered (PDC) and Medication Possession Ration (MPR) will be used to measure the compliance of index medication (Symbicort or Spiriva) during the 12 month post-index period.

  7. Treatment modification

    Time frame: 12 months

    COPD medication use, such as treatment changes, will be captured post-index.

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) and Tiotropium Bromide Among COPD Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 7, 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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