Asthma Comparative Effectiveness Study

NCT ID: NCT01623544

Last Updated: 2013-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6086 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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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

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

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Symbicort

BFC patients new to ICS/LABA combination therapy

No interventions assigned to this group

Advair

FSC patients new to ICS/LABA combination therapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 25439363 (View on PubMed)

Other Identifiers

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RWE-000015

Identifier Type: -

Identifier Source: org_study_id

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