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

NCT03055923 | Completed

• 1 other identifier: PHT/2016/93
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device.

  12 months

Secondary Outcomes (9)

• Disease severity as measured by Global Initiative for Asthma (GINA) Stage for asthma.

  12 months

• Disease severity as measured by Global Obstructive Lung Disease (GOLD) Stage for COPD.

  12 months

• Disease control as measured by the Asthma Control Questionnaire (ACQ) score for asthma patients.

  12 months

• Disease control as measured by the COPD Assessment Test (CAT) score for COPD patients.

  12 months

• Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) score in asthma patients

  12 months

Study Arms (3)

Asthma Patients

30 people who suffer from a confirmed diagnosis of asthma

Device: The Inflammacheck Device

Chronic Obstructive Pulmonary Disease Patients

30 people who suffer from a confirmed diagnosis of COPD

Device: The Inflammacheck Device

Healthy Controls

30 healthy volunteers who have no known diagnosis of Lung disease

Device: The Inflammacheck Device

Interventions

The Inflammacheck Device DEVICE

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

Asthma Patients; Chronic Obstructive Pulmonary Disease Patients; Healthy Controls

Eligibility Criteria

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

Study Population

Three populations of older adolescent and adult patients (all aged ≥16yrs) will be invited to participate: 1. Asthma patients (n=30) 2. COPD patients (n=30) 3. Comparator group (n=30) - Volunteers with no previous history of lung disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• Asthma UK: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof Anoop J Chauhan

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: February 16, 2017
• Study Start: November 14, 2016
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

GB (1)