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Exhaled Breath Condensate Biomarkers and Cough in IPF

Exhaled Breath Condensate Biomarkers and Cough in People With Idiopathic Pulmonary Fibrosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02630940
Enrollment
52
Registered
2015-12-15
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

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.

Interventions

None listed

Sponsors

University of East Anglia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
8-isoprostane levels1 day (Single measurement )Used for detection of 8-isoprostane levels in patients' exhaled breath condensate samples

Secondary

MeasureTime frameDescription
Leicester Cough Questionnaire1 day (Single measurement )Assessment of patient's cough severity
Kings brief interstitial lung disease questionnaire1 day (Single measurement )Assessment of patient's cough severity & exercise tolerance
MRC dyspnoea Scale1 day (Single measurement )Assessment of patient's exercise tolerance
Visual analogue scale for Cough1 day (Single measurement )Assessment of patient's cough severity
Non-validated acceptability questionnaire1 day (Single measurement )Assessment of exhaled breath condensate collection method acceptability

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026