AsthmaAsthma CERNCT01623544
Asthma Comparative Effectiveness Study
An observational study of Asthma, run by AstraZeneca.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 64 years
- Conditions the study is for
- Asthma
- How many people
- 6,086 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official 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
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.
Read the detailed description
A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients
- Conditions
- Asthma
- Keywords
- Asthma, Comparative Effectiveness, Symbicort
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symbicort | BFC patients new to ICS/LABA combination therapy | |
| Advair | FSC patients new to ICS/LABA combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of asthma exacerbations
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.
Measured: 12 months
Asthma Related Inpatient Hospitalizations
Measured: 12 months
Asthma Related Emergency Department visits
Measured: 12 months
Use of Oral Corticosteroids (OCS)
A pharmacy claim for any of the OCS medications
Measured: 12 months
Secondary outcomes (3)
Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)
Asthma controller use (0 vs. 1 and total number of fills for each).
Measured: 12 months
Asthma Related Healthcare Utilization
Asthma Related Healthcare Utilization: Outpatient/office visits, Inpatient length of stay, ICU admission and length of stay.
Measured: 12 months
Asthma Related Healthcare costs
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623544
- Sponsor's protocol ID
- RWE-000015
- Acronym
- Asthma CER
- Status last verified
- Feb 2013
- First submitted
- 18 Jun 2012
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tunceli O, Williams SA, Kern DM, Elhefni H, Pethick N, Wessman C, Zhou S, Trudo F. Comparative effectiveness of budesonide-formoterol combination and fluticasone-salmeterol combination for asthma management: a United States retrospective database analysis. J Allergy Clin Immunol Pract. 2014 Nov-Dec;2(6):719-26. doi: 10.1016/j.jaip.2014.07.016. Epub 2014 Oct 3.
PubMed 25439363
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01623544
- Acronym / sponsor ID
- Asthma CER / RWE-000015
- Conditions
- Asthma
- Keywords
- Asthma, Comparative Effectiveness, Symbicort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,086 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort | – | –BFC patients new to ICS/LABA combination therapy |
| Advair | – | –FSC patients new to ICS/LABA combination therapy |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Asthma Related Inpatient Hospitalizations
Time frame: 12 months
Asthma Related Emergency Department visits
Time frame: 12 months
Use of Oral Corticosteroids (OCS)
Time frame: 12 months
A pharmacy claim for any of the OCS medications
3 secondary outcomes
Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)
Time frame: 12 months
Asthma Related Healthcare Utilization
Time frame: 12 months
Asthma Related Healthcare costs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Derived from this study: PubMed 25439363Tunceli O, Williams SA, Kern DM, Elhefni H, Pethick N, Wessman C, Zhou S, Trudo F. Comparative effectiveness of budesonide-formoterol combination and fluticasone-salmeterol combination for asthma management: a United States retrospective database analysis. J Allergy Clin Immunol Pract. 2014 Nov-Dec;2(6):719-26. doi: 10.1016/j.jaip.2014.07.016. Epub 2014 Oct 3.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of asthma exacerbations (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01623544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.