The Asthma Bronchial Challenge Study

NCT ID: NCT03575663

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-25
• Study Completion Date: 2019-02-28

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

Indirect bronchial challenge

Mannitol dry powder inhalation

Intervention Type: DIAGNOSTIC_TEST

Sham bronchial challenge

Mock dry powder inhalation

Intervention Type: OTHER

Other Intervention Names

Osmohale / Aridol

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Asthma UK Centre for Applied Research

UNKNOWN

Sponsor Role: collaborator

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam M Peel, BSc

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Locations

University of East Anglia

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

Other Identifiers

2229225

Identifier Type: -

Identifier Source: org_study_id