- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623544
Asthma Comparative Effectiveness Study (Asthma CER)
February 22, 2013 updated by: AstraZeneca
A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients
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.
Study Overview
Status
Completed
Conditions
Detailed Description
A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients
Study Type
Observational
Enrollment (Actual)
6086
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 64 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Health plan members with asthma aged 12 to 64 years receiving two or more prescriptions for BFC or FSC during 6/1/2007-9/30/2010 who are naive to ICS/LABA combination therapy.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Symbicort
BFC patients new to ICS/LABA combination therapy
|
Advair
FSC patients new to ICS/LABA combination therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Asthma Related Inpatient Hospitalizations
Time Frame: 12 months
|
12 months
|
|
Asthma Related Emergency Department visits
Time Frame: 12 months
|
12 months
|
|
Use of Oral Corticosteroids (OCS)
Time Frame: 12 months
|
A pharmacy claim for any of the OCS medications
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
June 18, 2012
First Submitted That Met QC Criteria
June 19, 2012
First Posted (Estimate)
June 20, 2012
Study Record Updates
Last Update Posted (Estimate)
February 25, 2013
Last Update Submitted That Met QC Criteria
February 22, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RWE-000015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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