The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

NCT ID: NCT02140541

Last Updated: 2014-05-16

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

UNKNOWN

Total Enrollment

130248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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To explore the relationship between blood eosinophil counts, asthma exacerbations and patient asthma control using a large primary care based research database

Detailed Description

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Sputum eosinophil levels have been shown to predict asthma exacerbation and inhaled corticosteroid (ICS) responsivenesss. Managing asthma based on sputum eosinophils leads to fewer exacerbations than management adhering to Global Initiative for Asthma (GINA) guidelines. However the use of sputum to measure eosinophil levels is expensive and impractical within a clinical setting. This study explores the use of blood-eosinophil levels as a clinical predictor for exacerbations and asthma control within a UK primary care dataset.

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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Blood eosinophil count ≤ 400/µl

No interventions assigned to this group

Blood eosinophil count > 400/µl

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient aged 12-80 at date of last eosinophil count
* Asthma diagnosis at any time
* Blood Eosinophil reading in patient record (numeric count expressed in µl) at least one year prior to last data extraction
* Two years of continuous data

Exclusion Criteria

* Any other chronic respiratory diseases
* Eosinophil counts \>5000/µl (outliers)
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role collaborator

Research in Real-Life Ltd

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Price, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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Research in Real Life Ltd

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Deykin A, Lazarus SC, Fahy JV, Wechsler ME, Boushey HA, Chinchilli VM, Craig TJ, Dimango E, Kraft M, Leone F, Lemanske RF, Martin RJ, Pesola GR, Peters SP, Sorkness CA, Szefler SJ, Israel E; Asthma Clinical Research Network, National Heart, Lung, and Blood Institute/NIH. Sputum eosinophil counts predict asthma control after discontinuation of inhaled corticosteroids. J Allergy Clin Immunol. 2005 Apr;115(4):720-7. doi: 10.1016/j.jaci.2004.12.1129.

Reference Type BACKGROUND
PMID: 15805990 (View on PubMed)

Green RH, Brightling CE, McKenna S, Hargadon B, Parker D, Bradding P, Wardlaw AJ, Pavord ID. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet. 2002 Nov 30;360(9347):1715-21. doi: 10.1016/S0140-6736(02)11679-5.

Reference Type BACKGROUND
PMID: 12480423 (View on PubMed)

Price DB, Rigazio A, Campbell JD, Bleecker ER, Corrigan CJ, Thomas M, Wenzel SE, Wilson AM, Small MB, Gopalan G, Ashton VL, Burden A, Hillyer EV, Kerkhof M, Pavord ID. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015 Nov;3(11):849-58. doi: 10.1016/S2213-2600(15)00367-7. Epub 2015 Oct 19.

Reference Type DERIVED
PMID: 26493938 (View on PubMed)

Other Identifiers

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R05812

Identifier Type: -

Identifier Source: org_study_id

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