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The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

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ClinicalTrials.gov Identifier: NCT02140541
Recruitment Status : Unknown
Verified May 2014 by Research in Real-Life Ltd.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Research in Real-Life Ltd

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

Condition or disease
Asthma

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.

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Study Type : Observational
Actual Enrollment : 130248 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils
Study Start Date : February 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140541


Locations
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United Kingdom
Research in Real Life Ltd
Cambridge, United Kingdom, CB24 3BA
Sponsors and Collaborators
Research in Real-Life Ltd
Teva Pharmaceuticals USA
Investigators
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Principal Investigator: David Price, Prof, MD University of Aberdeen
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT02140541    
Other Study ID Numbers: R05812
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 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:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases