Clinical trial NCT03575663: The Asthma Bronchial Challenge Study
Official title: Bronchial Challenge Testing in Asthma: The Effect of Mannitol Dry Powder Inhalation on Volatile Organic Compounds in Exhaled Breath
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Breathomics
Metabolomics
Exhaled breath test
Biomarker
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Asthma UK Centre for Applied Research
First posted: 2018-07-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in exhaled breath profile
timeFrame: Immediately post-bronchial challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Adam M Peel, BSc
role: PRINCIPAL_INVESTIGATOR
References: