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 | Completed

• 1 other identifier: PHT/2017/120
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional, observational study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity and symptom control in patients with Asthma and COPD and volunteers with no history of lung disease.

Conditions

Asthma; COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Level of exhaled breath condensate hydrogen peroxide (EBC H2O2),

  EBC H202 as measured by the by Inflammacheck™ sensor

  1 day study visit

Secondary Outcomes (5)

• Quality of life (asthma specific)

  1 day study visit

• Quality of life (COPD specific)

  1 day study visit

• Safety outcome

  1 day study visit

• Disease Severity Asthma

  1 day study visit

• Disease Severity COPD

  1 day study visit

Eligibility Criteria

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

Study Population

Three populations of adult patients (all aged ≥18yrs) will be invited to participate: 1. Asthma patients (n=50, 25 mild, 25 severe) 2. COPD patients (n=50, 25 mild - moderate, 25 severe - very severe) 3. Comparator group (n=50) - Volunteers with no previous history of lung disease (our 'healthy' volunteers). These healthy volunteers will be recruited from the hospital staff. This will be facilitated by the hospital and research communications teams. Healthcare Professionals, who have assisted patients performing 'Inflammacheck™', alongside the standard respiratory tests of spirometry and FeNO, will be invited to participate in an experience outcome questionnaire at the end of the study.

You may qualify if:

• Male or Female, aged ≥16 years.
• A confirmed, clinician made diagnosis of asthma for ≥ 6months supported by evidence of any of the following;
• Airflow variability, with a variability in FEV1 or Peak Expiratory Flow (PEF) of \>20% across clinic visits within the preceding 5 years, with concomitant evidence of airflow obstruction (FEV1/FVC ratio \<70% on spirometry);
• Airway reversibility with an improvement in FEV1 by ≥12% or 200 ml after inhalation of 400 μg of salbutamol (or equivalent bronchodilator) via a metered dose inhaler and spacer within the preceding 5 years;
• Airway hyper-responsiveness demonstrated by Methacholine challenge testing with a provocative concentration of Methacholine required to cause a 20% reduction in FEV1 (PC20) of ≤ 16mg/ml or equivalent test.
• Mild Asthma defined as GINA steps 1 to 3
• Severe asthma defined as GINA steps 4 or 5
• OR a confirmed, clinician made diagnosis of COPD for ≥ 6months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC \<0.7).
• OR 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.
• Assisted a minimum of 5 patients in performing the collection of EBC H2O2 levels using the 'Inflammacheck™' device during the study.
• Willing and able to give informed consent for participation in the study.

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
• Known lung, chest wall, neuromuscular, or cardiac disease or abnormality that would confound symptom scores and spirometry.
• In the opinion of the clinical investigator, participant would not be able 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.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: August 19, 2019
• Study Start: February 3, 2018
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)