EXhaled Hydrogen Peroxide As a Marker of Lung diseasE (EXHALE) Pilot Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-14

Study Completion Date

2018-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and COPD from healthy individuals.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

Interstitial Lung Disease Lung Cancer

COMPLETED

Study to Explore the Relationship Between the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device Against Existing Measures of Lung Disease

NCT04061291

Asthma COPD Exacerbation

COMPLETED

A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD

NCT04024657

COPD Exacerbation

COMPLETED

Measuring Hydrogen Peroxide in Exhaled Breath Condensate in HV

NCT05844553

Proof Of Concept Study

COMPLETED

Investigation of Inflammacheck to Measure Exhaled Breath Condensate Hydrogen Peroxide in Respiratory Conditions

NCT04467190

Respiratory Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hydrogen Peroxide levels in Exhaled Breath Condensate (EBC) is a direct biomarker of oxidative stress from the airway epithelium. Levels have been shown to be raised in asthma and Chronic Obstructive Pulmonary Disease (COPD) both in stable and exacerbating states.

Previously it has been difficult to measure this volatile compound away from a laboratory based setting. However a new device has been developed to measure Hydrogen peroxide levels in exhaled breath by the patients side.

This Pilot study will test this new device in a clinical setting. It will assess whether the device can monitor levels consistently and reliably and whether it can distinguish disease from healthy individuals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asthma Patients

30 people who suffer from a confirmed diagnosis of asthma

The Inflammacheck Device

Intervention Type DEVICE

A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

Chronic Obstructive Pulmonary Disease Patients

30 people who suffer from a confirmed diagnosis of COPD

The Inflammacheck Device

Intervention Type DEVICE

A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

Healthy Controls

30 healthy volunteers who have no known diagnosis of Lung disease

The Inflammacheck Device

Intervention Type DEVICE

A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The Inflammacheck Device

A new hand-held, Non-invasive breathing test, that only requires tidal breathing.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject has a clinician made diagnosis of asthma with symptoms for ≥ 3 months supported by objective evidence of airflow variability, reversibility or airway hyper-responsiveness
* Subject has a confirmed, clinician made diagnosis of COPD for ≥ 3 months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC \<0.7) recorded at any time
* Subject has no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
* Subject is willing and able to give informed consent for participation in the study.

Exclusion Criteria

* Subject has existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
* Subject has known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
* Subject has received treatment for an exacerbation of their respiratory disease within the last 2 weeks.
* In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
* Subject is unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes