Exhaled Breath Condensate Biomarkers and Cough in IPF

Last updated: June 30, 2016
Sponsor: University of East Anglia
Overall Status: Completed

Phase

N/A

Condition

Cystic Fibrosis

Idiopathic Pulmonary Fibrosis

Lung Disease

Treatment

N/A

Clinical Study ID

NCT02630940
152379 (113-08-15)
  • Ages > 40
  • All Genders

Study Summary

Analysis of exhaled breath condensate biomarkers and cough severity in patients with idiopathic pulmonary fibrosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female above the age of 40

  • IPF diagnosed by a multi-disciplinary team meeting following review of clinicalhistory, thoracic high resolution computed tomography (HRCT) and/or surgical lungaccording to international guidelines

Exclusion

Exclusion Criteria:

  • A recognised significant co-existing respiratory disease, defined as a respiratorycondition that exhibits a clinically relevant effect on respiratory symptoms anddisease progression as determined by the principal investigator followingmulti-disciplinary discussion. For example, patients with bronchiectasis will only beincluded if the bronchiectasis is deemed to be traction bronchiectasis as a result ofidiopathic pulmonary fibrosis

  • Airflow obstruction defined as a forced expiratory volume at one second over forcedvital capacity (FEV1/FVC) <60% predicted or a residual volume greater than 120%predicted

  • Significant medical ,surgical or psychiatric disease that in the opinion of thepatient's attending physician would exhibit a clinically relevant effect on thepatient's health related quality of life

  • The patient is unable to provide written informed consent

Study Design

Total Participants: 52
Study Start date:
January 01, 2016
Estimated Completion Date:
June 30, 2016

Study Description

This study will aim to investigate the levels of the reactive oxygen species (ROS) 8-isoprostane in idiopathic pulmonary fibrosis patients' exhaled breath condensate (EBC). EBC samples will be collected using RTube, prior to analysis for levels of 8-isoprostane. An acceptability assessment will be performed for this non-invasive method of EBC collection through a non-validated questionnaire.

A regression analysis will then be performed for 8-isoprostane levels against the severity of the patient's cough, assessed through the use of the visual analogue scale for cough (VAS), the King's brief interstitial lung disease questionnaire (KBILD), the Medical Research Council (MRC) dyspnoea scale and the Leicester cough questionnaire. Alongside this an exploratory comparison of cough scores and 8 isoprostane concentration between patients with and without honeycombing and traction bronchiectasis.

Connect with a study center

  • University of East Anglia

    Norwich, Norfolk NR47TJ
    United Kingdom

    Site Not Available

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