Asthma COPDNCT06039943
Relationship Between Acoustic Breath Sounds and Spirometry
A study testing Wheeze measurement in people with Asthma COPD, run by University Hospital Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma COPD
- What is being tested?
- Wheeze measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Mar 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B75 7RR
Richard Glover, 01214247229, Richard.glover@uhb.nhs.uk
About this study
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
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.
- Conditions
- Asthma COPD
- Being tested
- Wheeze measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheeze measurementDevice
Acoustic breath sounds will be measured during tidal breathing prior to spirometry and during a spirometry attempt.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Participants will undergo wheeze monitoring during tidal breathing prior to spirometry and during a spirometry test. Receives: Device: Wheeze measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheeze score (Tw/Ttot%)
The average proportion of each breath that contained wheeze during a 30 second breath sound recording.
Measured: Day 1
FEV1/FVC
the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)
Measured: Day 1
FEV1
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start13 Mar 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Respiri US
- Responsible party
- Sponsor
- Investigators
- Richard Glover, Principal investigator, University Hospitals Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039943
- Sponsor's protocol ID
- RKK7649
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06039943
- Acronym / sponsor ID
- RKK7649
- Conditions
- Asthma COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- Respiri US
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Wheeze measurementParticipants will undergo wheeze monitoring during tidal breathing prior to spirometry and during a spirometry test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheeze measurementAcoustic breath sounds will be measured during tidal breathing prior to spirometry and during a spirometry attempt. | Device | All participants |
Primary outcome
Wheeze score (Tw/Ttot%)
Time frame: Day 1
The average proportion of each breath that contained wheeze during a 30 second breath sound recording.
FEV1/FVC
Time frame: Day 1
the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)
FEV1
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Glover principal investigator
University Hospitals Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheeze measurement in people with Asthma COPD, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brendan Cooper, PhD (01213713890, Brendan.Cooper@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheeze score (Tw/Ttot%) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.