The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2014 by Research in Real-Life Ltd.
Recruitment status was: Active, not recruiting

Sponsor:

Collaborator:

Teva Pharmaceuticals USA

Information provided by (Responsible Party):

Research in Real-Life Ltd

ClinicalTrials.gov Identifier:

NCT02140541

First received: May 14, 2014

Last updated: NA

Last verified: May 2014

History: No changes posted

Purpose

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

Condition
Asthma


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

Further study details as provided by Research in Real-Life Ltd:

Primary Outcome Measures:

Exacerbations [ Time Frame: 1 year ]
Defined as:
- American Thoracic Society / European Respiratory Society (ATS/ERS) task force definition: Asthma related hospital admissions OR accident and emergency (A&E) room attendance OR Use of acute oral steroids
- Clinical definition: ATS/ERS definition including any GP consultations for lower respiratory related tract infections (LRTIs) treated with antibiotics
Asthma control [ Time Frame: 1 year ]
Defined as:
- Risk domain asthma control: No Asthma-related hospital attendance, A&E attendance, out-patient department attendance, no prescriptions for acute oral steroids and no GP consultations for LRTIs treated with antibiotics
- Overall asthma control: Risk domain asthma control definition, including average daily dose of ≤200mcg salbutamol


Enrollment:	130248
Study Start Date:	February 2013
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Blood eosinophil count ≤ 400/µl
Blood eosinophil count > 400/µl

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	12 Years to 80 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

A retrospective database analysis of asthma patients with a valid eosinophil count (where valid: numeric value expressed as /µl at least one year prior to last data extraction) with at least one year of data of prior to the date of eosinophil count (baseline period) and one year of data post recorded eosinophil count (outcome period).

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02140541

Locations


United Kingdom
Research in Real Life Ltd
Cambridge, United Kingdom, CB24 3BA

Sponsors and Collaborators

Research in Real-Life Ltd

Teva Pharmaceuticals USA

Investigators


Principal Investigator:	David Price, Prof, MD	University of Aberdeen

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Research in Real-Life Ltd
ClinicalTrials.gov Identifier:	NCT02140541 History of Changes
Other Study ID Numbers:	R05812
Study First Received:	May 14, 2014
Last Updated:	May 14, 2014

Keywords provided by Research in Real-Life Ltd:


Asthma Blood eosinophils Sputum eosinophils	Clinical predictor UK primary care Global Initiative for Asthma (GINA)

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 17, 2017

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