CompletedNot Applicable

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

United Kingdom425 participantsStarted 2019-09-13

Plain-language summary

People with lung conditions can suffer significantly with their symptoms and often require multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult to diagnose lung disease and to differentiate between different lung conditions, so many people may be misdiagnosed or incorrectly not given a diagnosis. The tests currently used to diagnose lung diseases can be difficult or uncomfortable to do, especially if the person is experiencing lots of symptoms, and therefore can give poor or unreliable results.A new quick and easy to perform test is needed that can differentiate between various lung conditions and people with no lung disease, that can be performed in primary and secondary care with immediate results.

Who can participate

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or Female, aged ≥16 years * A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria): * Asthma with a ≤10 pack year smoking history (confirmed by spirometry and/or airway inflammation and function tests) * COPD (confirmed by spirometry) * Bronchiectasis (confirmed by CT scan) * Interstitial Lung Disease (confirmed by CT scan and MDT/specialist consensus) * has or is eventually proven to have a histological OR radiological and MDT confirmed diagnosis of primary lung cancer, and not yet started treatment for this * current pneumonia (confirmed by chest imaging) * Breathing Pattern Disorder, with no other significant respiratory co-morbidity (specialist confirmed) * Healthy controls (defined as no current clinical diagnosis of, or be receiving treatment for, a lung or other significant medical disorder). * Willing and able to give informed consent for participation in the study. * In a stable state (at least 4 weeks after treatment of an exacerbation of their respiratory disease) Exclusion Criteria: * Existing co-morbidities that may prevent them from performing spirometry, for those with asthma, COPD, or healthy controls, with no spirometry in the previous 12 months (at the discretion of the clinical investigator). * Unable to comprehend the study, provide informed consent, and unable to perform any of the study procedures. * Requirement of supplemental oxygen (pneumonia participants only)

What they're measuring

To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions

Timeframe: immediately after the procedure (breathing into device)

To measure humidity levels in EBC in patients with a range of commonly occurring respiratory conditions

Timeframe: immediately after the procedure (breathing into device)

To measure the breath temperature in EBC in patients with a range of commonly occurring respiratory conditions

Timeframe: immediately after the procedure (breathing into device)

To measure CO2 waveform in patients with a range of commonly occurring respiratory conditions

Timeframe: immediately after the procedure (breathing into device)

To measure intrathoracic pressure in patients with a range of commonly occurring respiratory conditions

Timeframe: immediately after the procedure (breathing into device)

Trial details

NCT IDNCT04467190

SponsorPortsmouth Hospitals NHS Trust

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2022-10-13

View on ClinicalTrials.gov More Respiratory Disease trials