Asthma Breath Biomarker Assessment

Asthma Acute Clinical Trial

— ABBA  

Official title:

Exhaled Breath Biomarkers in Acute Asthma: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084016
• Other study ID #: 197935
• Status: Completed
• Start date: March 6, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2022
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the feasibility of capturing data on exhaled breath compounds during an acute asthma exacerbation. In addition to assessing the feasibility of such a study the investigators will collect data on exploratory outcomes including the ability of breath biomarkers to distinguish between controlled and exacerbated states and their ability to differentiate between triggers of exacerbation.

Description:

This will be a longitudinal observational study in which the investigators assess the ability to capture information on volatile organic compounds in exhaled breath during an acute asthma exacerbation using two different approaches: A) Recruitment and assessment of patients in secondary care during an acute exacerbation of their asthma; patients to be re-assessed once their asthma is stable and controlled. B) Recruitment of clinically stable outpatients who are at increased risk of exacerbation by virtue of having had an acute exacerbation within the previous 12 months. Participants to be followed for a period of up to 12 months; assessed in the event of an exacerbation; and re-assessed once controlled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female

2. Aged 18 or above

3. Able to provide informed consent

4. A confirmed asthma diagnosis requiring treatment with inhaled bronchodilator therapy +/- inhaled corticosteroids.

5. Non-smoker (or ex-smoker of 6 months or more with a less than 10 pack year history).

6. Current exacerbation or exacerbation within the previous 12 months.

7. Within 24 hours of having presented to acute secondary care (applicable to current exacerbation only)

Exclusion Criteria:

1. Major chronic cardiorespiratory disease other than asthma

2. Significant comorbid condition

3. Receiving maintenance oral corticosteroid therapy or other immunosuppressant or immunomodulatory therapy (including biologics)

4. Pregnant

5. Participating in a clinical trial of an investigational medicinal product (CTIMP).

6. Unable to speak English.

Related Conditions & MeSH terms

• Asthma
• Asthma Acute

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study feasibility - recruitment	Recruitment rate	18 months
Primary	Study feasibility - assessment	Percentage of participants who experience an exacerbation, contact the study team and complete an assessment	18 months
Primary	Study feasibility - patient acceptability	Patient acceptability of breath capture devices (assessed by questionnaire)	18 months
Secondary	Breath profile of exhaled volatile organic compounds (VOCs).	A profile of VOCs in exhaled breath obtained through gas chromatography-mass spectrometry during asthma exacerbation and when stable.	12 months

External Links

•   PhD thesis