Exhaled Breath Condensate Biomarkers and Cough in IPF

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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR47TJ
      • University of East Anglia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or Female Idiopathic pulmonary fibrosis sufferers over the age of 40, who have been diagnosed in accordance with either a multi-disciplinary review of their clinical history, thoracic high resolution computed tomography and/or surgical lung according to international guidelines

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Idiopathic pulmonary fibrosis sufferers; Male or female idiopathic pulmonary fibrosis (IPF) sufferers over the age of 40, with a confirmed diagnosis of IPF against international guidelines. Patients are devoid of significant other medical, surgical or psychiatric illnesses that may affect respiratory symptoms or disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
8-isoprostane levels	Used for detection of 8-isoprostane levels in patients' exhaled breath condensate samples	1 day (Single measurement )

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of East Anglia
• Investigators: Principal Investigator: Andrew M Wilson, MD MRCP, University of East Anglia; Principal Investigator: Christopher Atkins, MBBS, University of East Anglia; Principal Investigator: Ashnish Sinha, University of East Anglia

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 152379 (113-08-15)