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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06039943
Other study ID # RKK7649
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date August 1, 2024

Study information

Verified date September 2023
Source University Hospital Birmingham
Contact Brendan Cooper, PhD
Phone 01213713890
Email Brendan.Cooper@uhb.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess whether wheeze as assessed by a commercially available wheeze monitor is comparable to lung function as measured during a spirometry test. The main questions it aims to answer are whether measures of airflow obstruction (FEV1, FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%). Participants consenting to take part will undergo wheeze measurement prior to and during a spirometry test and will be asked to complete a series of symptom questionnaires.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Consenting adult (aged 18-95) University Hospitals Birmingham patient's attending the Lung Function and Sleep Department (LF&S) routinely as part of their standard clinical management pathway for Lung Function testing that includes Spirometry assessments. - All patients irrespective of condition will be approached to participate. Exclusion Criteria: - Subjects who are contraindicated to perform spirometry on the day of testing - Subjects who cannot speak or read English - Patients accessing non-adult services - Subjects who are unable or do not wish to consent - Patients with known or suspected restrictive lung disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Wheeze measurement
Acoustic breath sounds will be measured during tidal breathing prior to spirometry and during a spirometry attempt.

Locations

Country Name City State
United Kingdom University Hospitals Birmingham NHS Foundation Trust Birmingham West Midlands

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Birmingham Respiri US

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wheeze score (Tw/Ttot%) The average proportion of each breath that contained wheeze during a 30 second breath sound recording. Day 1
Primary FEV1/FVC the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) Day 1
Primary FEV1 Day 1
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