Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers.

NCT04061356 | Completed

• 1 other identifier: PHT/2017/121
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity in patients with ILD and Lung Cancer.

Conditions

Interstitial Lung Disease; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Level of exhaled breath condensate hydrogen peroxide (EBC H2O2)

  Respiratory outcome EBC H2O2 levels as measured by 'Inflammacheck™'

  1 day study visit

Secondary Outcomes (4)

• Experience outcome

  1 day study visit

• Disease Stage (lung cancer)

  1 day study visit

• Disease stage (interstitial lung disease)

  1 day study visit

• safety outcome

  1 day study visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 75 participants will be recruited, comprised of 50 participants with an established diagnosis that affects their breathing and 25 participants with no history of disease (healthy volunteers).

You may qualify if:

• Male or Female, aged ≥18 years.
• A confirmed, clinician made diagnosis of Interstitial Lung Disease (ILD) supported by evidence of ILD on a CT chest scan recorded at any time.
• OR a clinician suspected or confirmed Lung Cancer, with or without asthma and/or COPD
• OR a healthy volunteer with no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
• Willing and able to give informed consent for participation in the study.

You may not qualify if:

• Existing co-morbidities that may prevent them from performing spirometry or other study measurements (at the discretion of the clinical investigator).
• Known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
• In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
• Unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: August 19, 2019
• Study Start: October 30, 2018
• Primary Completion: September 14, 2019
• Study Completion: September 14, 2019
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)