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

NCT04467190 | Completed

• 1 other identifier: PHT/2019/77
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (5)

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

  levels of H2O2 in Exhaled Breath Condensate

  immediately after the procedure (breathing into device)

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

  level of humidity in breath in Exhaled Breath Condensate

  immediately after the procedure (breathing into device)

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

  temperature of breath in Exhaled Breath Condensate

  immediately after the procedure (breathing into device)

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

  exhaled CO2 waveform

  immediately after the procedure (breathing into device)

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

  intrathoracic pressure

  immediately after the procedure (breathing into device)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with respiratory disease or healthy controls as defined in the inclusion and exclusion criteria

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: July 10, 2020
• Study Start: September 13, 2019
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)