NCT02140541

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130,248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

1.4 years

First QC Date

May 14, 2014

Last Update Submit

May 14, 2014

Conditions

Asthma

Keywords

AsthmaBlood eosinophilsSputum eosinophilsClinical predictorUK primary careGlobal Initiative for Asthma (GINA)

Outcome Measures

Primary Outcomes (2)

  • Exacerbations

    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

    1 year

  • Asthma control

    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

    1 year

Study Arms (2)

Blood eosinophil count ≤ 400/µl

Blood eosinophil count > 400/µl

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Any other chronic respiratory diseases
  • Eosinophil counts \>5000/µl (outliers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research in Real Life Ltd

Cambridge, CB24 3BA, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 15805990BACKGROUND

  • 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.

    PMID: 12480423BACKGROUND

  • 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.

    PMID: 26493938DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • David Price, Prof, MD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

GB(1)