Exhaled Breath Condensate Biomarkers and Cough in IPF

Completed

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT02630940
• Lead Sponsor: University of East Anglia

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-15
• Study Start: 2016-01
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Male or female above the age of 40
• IPF diagnosed by a multi-disciplinary team meeting following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or surgical lung according to international guidelines

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Exclusion Criteria

• A recognised significant co-existing respiratory disease, defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the principal investigator following multi-disciplinary discussion. For example, patients with bronchiectasis will only be included if the bronchiectasis is deemed to be traction bronchiectasis as a result of idiopathic pulmonary fibrosis
• Airflow obstruction defined as a forced expiratory volume at one second over forced vital capacity (FEV1/FVC) <60% predicted or a residual volume greater than 120% predicted
• Significant medical ,surgical or psychiatric disease that in the opinion of the patient's attending physician would exhibit a clinically relevant effect on the patient's health related quality of life
• The patient is unable to provide written informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
8-isoprostane levels	1 day (Single measurement )	Used for detection of 8-isoprostane levels in patients' exhaled breath condensate samples

Secondary Outcome Measures

Name	Time	Method
Leicester Cough Questionnaire	1 day (Single measurement )	Assessment of patient's cough severity
MRC dyspnoea Scale	1 day (Single measurement )	Assessment of patient's exercise tolerance
Non-validated acceptability questionnaire	1 day (Single measurement )	Assessment of exhaled breath condensate collection method acceptability
Kings brief interstitial lung disease questionnaire	1 day (Single measurement )	Assessment of patient's cough severity \& exercise tolerance
Visual analogue scale for Cough	1 day (Single measurement )	Assessment of patient's cough severity

Trial Locations

Locations (1)

University of East Anglia; 🇬🇧 Norwich, Norfolk, United Kingdom