Asthma COPD Clinical Trial
Official title:
A Comparative Single Centre Study Assessing the Relationship Between Acoustic Breath Sounds as Measured by a Commercially Available Sound Recording Device Against Standard of Care (Spirometry) in the Assessment of Airflow Obstruction in Patients Who Plan to Undergo Spirometry Testing
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
University Hospital Birmingham | Respiri US |
United Kingdom,
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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