The Asthma Bronchial Challenge Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indirect bronchial challenge

Diagnostic Test

Mannitol dry powder inhalation

Other names: Osmohale / Aridol

Sham bronchial challenge

Other

Mock dry powder inhalation

Primary outcomes

Changes in exhaled breath profile

Time frame: Immediately post-bronchial challenge

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.

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Collaborators

Asthma UK Centre for Applied Research
University of Manchester

Registry information

Official study title

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

Acronym: ABC

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 2, 2018
Registry last updated: Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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