The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

May 14, 2014 updated by: Research in Real-Life Ltd
To explore the relationship between blood eosinophil counts, asthma exacerbations and patient asthma control using a large primary care based research database

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

130248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Blood eosinophil count ≤ 400/µl
Blood eosinophil count > 400/µl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research in Real-Life Ltd

Collaborators

Teva Pharmaceuticals USA

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R05812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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