Clinical trial NCT02140541: The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils
Official title: The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
Blood eosinophils
Sputum eosinophils
Clinical predictor
UK primary care
Global Initiative for Asthma (GINA)
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2014-05-16
Enrollment: 130248
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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

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 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)

Primary outcomes:
measure: Exacerbations
timeFrame: 1 year
measure: Asthma control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Research in Real Life Ltd
Study officials:
affiliation: University of Aberdeen
name: David Price, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.