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Completed

NCT Number: NCT02630940

Exhaled Breath Condensate Biomarkers and Cough in IPF

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 8-isoprostane levels

    Time frame: 1 day (Single measurement )

    Used for detection of 8-isoprostane levels in patients' exhaled breath condensate samples

Secondary outcomes

  1. Leicester Cough Questionnaire

    Time frame: 1 day (Single measurement )

    Assessment of patient's cough severity

  2. Kings brief interstitial lung disease questionnaire

    Time frame: 1 day (Single measurement )

    Assessment of patient's cough severity & exercise tolerance

  3. MRC dyspnoea Scale

    Time frame: 1 day (Single measurement )

    Assessment of patient's exercise tolerance

  4. Visual analogue scale for Cough

    Time frame: 1 day (Single measurement )

    Assessment of patient's cough severity

  5. Non-validated acceptability questionnaire

    Time frame: 1 day (Single measurement )

    Assessment of exhaled breath condensate collection method acceptability

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2015
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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