The Asthma Bronchial Challenge Study (ABC)

Bronchial Challenge Testing in Asthma: The Effect of Mannitol Dry Powder Inhalation on Volatile Organic Compounds in Exhaled Breath

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Diagnostic test: Indirect bronchial challenge; Other: Sham bronchial challenge

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR47TJ
      • University of East Anglia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of East Anglia
• Collaborators: University of Manchester; Asthma UK Centre for Applied Research
• Investigators: Principal Investigator: Adam M Peel, BSc, University of East Anglia

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): February 19, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Biomarker; Metabolomics; Breathomics; Exhaled breath test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2229225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No