Clinical trial · Observational
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.
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. The EXHALE 1B Study
NCT04061356CI-TRIAL-00065412EXHALE 1BcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Interstitial Lung Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Level of exhaled breath condensate hydrogen peroxide (EBC H2O2)
- timeFrame
- 1 day study visit
- description
- Respiratory outcome EBC H2O2 levels as measured by 'Inflammacheck™'
Secondary outcomes (4)
- measure
- Experience outcome
- timeFrame
- 1 day study visit
- description
- rating of ease of use of test and participants perception of device as assessed by self completion questionnaire
- measure
- Disease Stage (lung cancer)
- timeFrame
- 1 day study visit
- description
- measured by Tumour, Node, Metastasis stage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.