The Asthma Bronchial Challenge Study

Asthma Clinical Trial

— ABC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575663
• Other study ID #: 2229225
• Status: Completed
• Start date: April 25, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2018
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 28, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Diagnostic Test:
• Indirect bronchial challenge
Mannitol dry powder inhalation

Other:
• Sham bronchial challenge
Mock dry powder inhalation

Locations

Country	Name	City	State
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (3)

Lead Sponsor	Collaborator
University of East Anglia	Asthma UK Centre for Applied Research, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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