The Asthma Bronchial Challenge Study

NCT03575663 | Completed

• 1 other identifier: 2229225
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised, controlled, cross-over study to determine the effect of indirect bronchial challenge testing upon volatile organic compounds (VOCs) in the exhaled breath of adults with well-controlled, mild-to-moderate asthma. Participants will undergo baseline evaluation including clinical history, spirometry, exhaled nitric oxide measurement (FeNO), phlebotomy (blood eosinophil count), and sampling of exhaled breath VOCs. Participants will be randomised to receive either an indirect bronchial challenge test using mannitol dry powder (MDP) or a sham bronchial challenge, followed by further sampling of breath VOCs. The study will consist of a consent visit and two assessment visits with participants allocated to receive one of the two challenges (MDP or sham) at each assessment. Data will be analysed to determine the effect of bronchial challenge upon exhaled breath VOC profiles.

Conditions

Asthma

Keywords

Breathomics; Metabolomics; Exhaled breath test; Biomarker

Outcome Measures

Primary Outcomes (1)

• Changes in exhaled breath profile

  Exhaled volatile organic compounds (VOCs) will be captured on sorbent material and analysed by gas chromatography-mass spectrometry. Post-bronchial challenge samples will be compared with baseline, pre-challenge samples. Differences in exhaled VOC profile will be assessed for significance.

  Immediately post-bronchial challenge

Interventions

Indirect bronchial challenge DIAGNOSTIC_TEST

Mannitol dry powder inhalation

Also known as: Osmohale / Aridol

Sham bronchial challenge OTHER

Mock dry powder inhalation

Eligibility Criteria

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

Study Population

Adults with well-controlled, mild asthma, managed in primary care and treated at level 1 to 2 of the British Thoracic Society treatment guidelines.

You may qualify if:

• Male or female
• Aged 18 or over
• Able to provide informed consent
• Self-report of asthma diagnosis from health professional
• Diagnostic confirmation meeting British Thoracic Society guidelines will be sought from primary care
• Non-smokers; or ex-smokers of at least two years duration with less than a ten pack year history
• Asthma Control Questionnaire score \< 1.0
• Asthma treated according to level-1 to level-2 of British Thoracic Society treatment guidelines

You may not qualify if:

• Respiratory tract infection, asthma exacerbation or change in treatment step within the previous four weeks
• Major chronic cardiorespiratory disease other than asthma
• Significant comorbid condition
• Condition that may be compromised by repeated spirometry manoeuvres or induced bronchospasm
• Asthma Control Questionnaire score \>1.0
• Asthma treated at level 3 of the treatment guidelines or higher
• Pregnant or nursing mothers
• Current smokers or 'vapers'
• Ex-smokers of \< 2 years duration or \> 10 pack years.
• Participating in a clinical trial of an investigational medicinal product (CTIMP).
• Unable to speak English.
• Low baseline lung function (FEV1 \<1.50 litres or \< 70% predicted value)
• Known hypersensitivity to mannitol, gelatin or strong anaphylactic response in the past.

Sponsors & Collaborators

• University of East Anglia: lead
• University of Manchester: collaborator
• Asthma UK Centre for Applied Research: collaborator

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Volatile organic compounds obtained through sampling exhaled breath

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 Officials

• Adam M Peel, BSc

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 2, 2018
• Study Start: April 25, 2018
• Primary Completion: February 19, 2019
• Study Completion: February 28, 2019
• Last Updated: April 25, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)