Measuring Hydrogen Peroxide in Exhaled Breath Condensate in COPD

NCT06788457 | Completed

• 1 other identifier: 21IC7212
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Following a successful pilot study and a clinical assessment in healthy volunteers (ClinicalTrials.gov ID: NCT05844553) this study aims to evaluate the accuracy and precision of an Exhaled Breath Condensate (EBC) device in patients with COPD. The study will evaluate the reproducibility of 3 measurements a month apart in real breath samples. This will take place at the Clinical Research Facility (CRF) at the Royal Brompton Hospital. Real biological specimens are complex and there is the potential for losses of precision and accuracy. This can only be evaluated by comparison with established methodology. Secondly, whilst many reports can correctly classify COPD patients, there are substantial variations in absolute levels between researchers. It has been shown with artificial samples that correcting for variations in heat and mass transport can substantially reduce these variations. Collecting replicate samples from patients with COPD will allow the evaluation within this patient group.

Conditions

Proof of Concept Study

Outcome Measures

Primary Outcomes (1)

• Precision and accuracy of the EBC device in COPD & healthy participants.

  This will be assessed by comparison with the gold standard fluorometry and mass spectrometry methods.

  12 months

Study Arms (2)

Healthy participants

Healthy individuals, free of significant disease.

Device: Exhaled Breath Condensate

Participants with COPD

A diagnosis of COPD.

Device: Exhaled Breath Condensate

Interventions

Exhaled Breath Condensate DEVICE

Measurement of hydrogen peroxide in exhaled breath

Healthy participants; Participants with COPD

Eligibility Criteria

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

Study Population

Participants with COPD and Heathy participants

You may qualify if:

• COPD participants:
• A diagnosis of COPD.
• Not current smokers
• Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 1 month).
• Able to give written informed consent prior to participation in the study including all of its procedures.
• Male or female subject aged 18 years and above at screening.
• Able to complete the study and all measurements.
• Able to read, comprehend, and write at a sufficient level to complete study related materials
• Healthy subjects:
• non-smokers
• Healthy individuals, free of significant disease.
• Able to give written informed consent prior to participation in the study including all of its procedures.
• Able to comply with the requirements and restrictions listed in the consent form.
• Male or female subject aged 18 years and above at screening.
• Able to complete the study and all measurements.

You may not qualify if:

• COPD Participants:
• We will not recruit subjects who lack the capacity to consent.
• Current or past diagnosis of asthma.
• History of any chronic respiratory diseases other than COPD.
• History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
• Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks).
• Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening.
• Patients who have evidence of alcohol or substance abuse.
• Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.
• Those, in the opinion of the investigator, who may prove non-compliant with study procedures.
• History of an upper or lower respiratory infection (including coryza) within 3 weeks of baseline assessments (assessments and entry could be deferred.
• Healthy subjects:
• A history of recreational drug use or allergy which in the opinion of the investigators contra-indicates their participation.
• Participation within 3 months in any other study testing a new molecular entity or drug or involving invasive procedures.
• Those, in the opinion of the investigator, who may prove non-compliant with study procedures.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Clinical Research Facility, Royal Brompton Hospital

London, SW3 6LY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Exhaled breath condensate (EBC)

Study Officials

• Omar Usmani, MBBS, MRCP, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 23, 2025
• Study Start: May 10, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)