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Completed

NCT Number: NCT01623544

Asthma Comparative Effectiveness Study

The objective of this study is to compare the real-world effectiveness of BFC and FSC in asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan enrollees.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–64 year

Sex eligibility

All sexes

Study type

Observational

About this study

A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients

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 two prescription fills for BFC or FSC within 12 months
  • Asthma claims diagnosis, and 12 to 64 years of age at the time of first prescription

Exclusion criteria

  • Evidence of COPD
  • Claims diagnosis of any of inflammatory diseases or cancer
  • Presence of Rx for more than one type of ICS/LABA combination on index date
  • Chronic steroid use or Xolair use prior to ICS/LABA index treatment

Treatment and study plan

Primary outcomes

  1. Rate of asthma exacerbations

    Time frame: 12 months

    The rate is defined as the total number of asthma exacerbations for all patients in the cohort divided by the total number of person years. An asthma exacerbation is defined as any of three conditions: Asthma related inpatient hospitalization or Asthma related emergency department visit or Oral corticosteroid use.

  2. Asthma Related Inpatient Hospitalizations

    Time frame: 12 months

  3. Asthma Related Emergency Department visits

    Time frame: 12 months

  4. Use of Oral Corticosteroids (OCS)

    Time frame: 12 months

    A pharmacy claim for any of the OCS medications

Secondary outcomes

  1. Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)

    Time frame: 12 months

    Asthma controller use (0 vs. 1 and total number of fills for each).

  2. Asthma Related Healthcare Utilization

    Time frame: 12 months

    Asthma Related Healthcare Utilization: Outpatient/office visits, Inpatient length of stay, ICU admission and length of stay.

  3. Asthma Related Healthcare costs

    Time frame: 12 months

    Asthma Related Healthcare costs (plan paid, patient paid and plan + patient paid)costs of all Asthma related medication and Asthma related outpatient/office, ED and Inpatient visits.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients

Acronym: Asthma CER

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
Feb 25, 2013

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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