Large Airway CollapseRE-LACSNCT07504926
A Randomised Feasibility Study of CPAP in Large Airway Collapse
A study testing CPAP in people with Large Airway Collapse and Asthma, run by Liverpool School of Tropical Medicine at 1 site in United Kingdom.
Trial summary
Large airway collapse (LAC) is an increasingly recognised condition characterised by either bowing of the posterior membrane/trachealis muscle into the trachea or main bronchi (also known as excessive dynamic airway collapse, EDAC) or weakening of the tracheal cartilage (also known as tracheobronchomalacia, TBM).(1-3)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Airway Collapse, Asthma
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult (≥18 years) at visit 1
- Able to provide informed consent
- Prior confirmation of LAC (diagnosed either radiographically or with bronchoscopy)
- Respiratory co-morbidities optimised
- ≥1 course of antibiotics and/or prednisolone for an exacerbation of chronic airway disease in the preceding 12 months before visit 1.
Who cannot join
- Contraindication to CPAP as per British Thoracic Society (BTS) guidelines
- Already using domiciliary CPAP (including privately purchased)
- Known obstructive sleep apnoea syndrome (OSAS) eligible for CPAP
- Suspected OSAS that is awaiting further investigation
- Pregnant or planning a pregnancy in the next 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Liverpool Hospital
Liverpool
Rachel Burton, MD, 01517062000 ext. 00, rachel.burton@liverpoolft.nhs.uk
About this study
Large airway collapse (LAC) is an increasingly recognised condition characterised by either bowing of the posterior membrane/trachealis muscle into the trachea or main bronchi (also known as excessive dynamic airway collapse, EDAC) or weakening of the tracheal cartilage (also known as tracheobronchomalacia, TBM).(1-3) LAC often co-exists with other chronic airway conditions, such as asthma or chronic obstructive pulmonary disease (COPD) and is frequently misdiagnosed or overlooked as symptoms, such as shortness of breath, cough and wheeze overlap with other respiratory disease.(1) There is no standardised treatment pathway for patients diagnosed with LAC and current treatment options are limited to physiotherapy and/or hypertonic saline.(3) Exacerbations of LAC, defined as an acute worsening of respiratory symptoms, typically reduce health-related quality of life and increase healthcare utilisation.(4) Small studies and case series have suggested continuous positive airway pressure (CPAP) as a potential treatment for LAC to reduce exacerbations and improve quality of life.(5,6) It is hypothesised CPAP may work as a pneumatic splint helping to prevent dynamic collapse of the large airways. This may increase lung volumes due to increase in flow at functional residual capacity (FRC) and support higher elastic recoil and increased expiratory flow. Additionally, splinting of the large airways may cause stiffening of the large airways, resulting in less resistance and turbulence during expiration and may support sputum expectoration.(3) There is a need for high quality randomised controlled trial (RCT) evidence to inform clinical recommendations in the United Kingdom (UK), as well as globally. Prior to this there is a need for further work exploring the feasibility of performing a large RCT and understanding the acceptability of CPAP as a future treatment for LAC.
Aim To conduct a randomised feasibility study that will provide data to confirm if a larger randomised trial of CPAP in patients diagnosed with LAC is viable
- Conditions
- Large Airway Collapse, Asthma
- Being tested
- CPAP
- Keywords
- CPAP, Large Airways Collapse, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Nocturnal CPAP
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of care for LACS. Which includes physio and good asthma management |
| Intervention (CPAP) | Experimental | Nocturnal CPAP Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient acceptability
- All participants will be asked to complete a questionnaire, which will give us information about their diagnosis pathway, current health and wellbeing related to LAC and other information about treatment options.
- Participation in an audio-recorded semi-structured interview will be offered to participants in both arms, to facilitate the collection of more detailed insights surrounding LAC as a condition, diagnosis pathway, treatments (including CPAP). Interview topic guides will be co-produced with the patient and public involvement (PPI) lead. Interviews will be scheduled at the patient's convenience on or after visit 3 (6 months) and will be conducted face-to-face, virtually or by telephone. We will aim to interview up to 10 participants in each arm, or until data saturation is reached. Interviews will be recorded using industry standard recording device/Dictaphone, transcribed, and data analysed under the guidance of the qualitative lead.
Measured: From Enrolment until 1 year
Recruitment and Retention
The site will be asked to keep a screening log of all patients identified, approached and given an information leaflet.
The number of participants enrolled (defined as a participant providing written informed consent) and the proportion randomised will be reported. Reasons for screen failure and withdrawal will be collected and summarised in the CRF.
Recruitment and retention will be periodically assessed in line with agreed targets with the funder.
Measured: At 18 months post enrolment
Secondary outcomes (2)
Health Related Quality of Life Assessment
The SGRQ is a 50-item questionnaire used to assess the health and wellbeing of patients with chronic respiratory disease. The questionnaire is composed of 2 parts: part 1 measures symptom burden and part 2 ascertains the impact of their disease on a range of activities that encompass social function, psychological disturbance and physical ability. Scores range from 0 to 100 with a higher score indicating more limitations.
The SGRQ will be administered at all on-site visits. A total score will be collected to analyse participant trajectories over the duration of the study and conduct comparative analyses between study arms, considering minimally important clinical differences.
Measured: At enrolment and 18 months
Healthcare Resource Utilisation
- Primary care (General Practitioner (GP), nurse, other)
- Secondary care (respiratory, non-respiratory, consultant, nurse, or other), community service (pharmacist, other)
- Emergency department attendance (respiratory or non-respiratory)
- Inpatient admission (elective, emergency), admission duration
Measured: At 18 months post enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start20 Apr 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Airway CollapseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Liverpool University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504926
- Sponsor's protocol ID
- 342137
- Acronym
- RE-LACS
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Study of CPAP in Large Airway Collapse
- ClinicalTrials.gov ID
- NCT07504926
- Acronym / sponsor ID
- RE-LACS / 342137
- Conditions
- Large Airway Collapse, Asthma
- Keywords
- CPAP, Large Airways Collapse, Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Royal Liverpool University Hospital
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 1 Apr 2026 (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.
Large airway collapse (LAC) is an increasingly recognised condition characterised by either bowing of the posterior membrane/trachealis muscle into the trachea or main bronchi (also known as excessive dynamic airway collapse, EDAC) or weakening of the tracheal cartilage (also known as tracheobronchomalacia, TBM).(1-3) LAC often co-exists with other chronic airway conditions, such as asthma or chronic obstructive pulmonary disease (COPD) and is frequently misdiagnosed or overlooked as symptoms, such as shortness of breath, cough and wheeze overlap with other respiratory disease.(1) There is no standardised treatment pathway for patients diagnosed with LAC and current treatment options are limited to physiotherapy and/or hypertonic saline.(3) Exacerbations of LAC, defined as an acute worsening of respiratory symptoms, typically reduce health-related quality of life and increase healthcare utilisation.(4) Small studies and case series have suggested continuous positive airway pressure (CPAP) as a potential treatment for LAC to reduce exacerbations and improve quality of life.(5,6) It is hypothesised CPAP may work as a pneumatic splint helping to prevent dynamic collapse of the large airways. This may increase lung volumes due to increase in flow at functional residual capacity (FRC) and support higher elastic recoil and increased expiratory flow. Additionally, splinting of the large airways may cause stiffening of the large airways, resulting in less resistance and turbulence during expiration and may support sputum expectoration.(3) There is a need for high quality randomised controlled trial (RCT) evidence to inform clinical recommendations in the United Kingdom (UK), as well as globally. Prior to this there is a need for further work exploring the feasibility of performing a large RCT and understanding the acceptability of CPAP as a future treatment for LAC.
Aim To conduct a randomised feasibility study that will provide data to confirm if a larger randomised trial of CPAP in patients diagnosed with LAC is viable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of care for LACS. Which includes physio and good asthma management |
| Intervention (CPAP) | Experimental | Device: CPAPNocturnal CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (≥18 years) at visit 1
- Able to provide informed consent
- Prior confirmation of LAC (diagnosed either radiographically or with bronchoscopy)
- Respiratory co-morbidities optimised
- ≥1 course of antibiotics and/or prednisolone for an exacerbation of chronic airway disease in the preceding 12 months before visit 1.
Key exclusion criteria (5 listed)
- Contraindication to CPAP as per British Thoracic Society (BTS) guidelines
- Already using domiciliary CPAP (including privately purchased)
- Known obstructive sleep apnoea syndrome (OSAS) eligible for CPAP
- Suspected OSAS that is awaiting further investigation
- Pregnant or planning a pregnancy in the next 12 months
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 |
|---|---|---|
| CPAPNocturnal CPAP | Device | Intervention (CPAP) |
Primary outcome
Patient acceptability
Time frame: From Enrolment until 1 year
1. All participants will be asked to complete a questionnaire, which will give us information about their diagnosis pathway, current health and wellbeing related to LAC and other information about treatment options. 2. Participation in an audio-recorded semi-structured interview will be offered to participants in both arms, to facilitate the collection of more detailed insights surrounding LAC as a condition, diagnosis pathway, treatments (including CPAP). Interview topic guides will be co-produced with the patient and public involvement (PPI) lead. Interviews will be scheduled at the patient's convenience on or after visit 3 (6 months) and will be conducted face-to-face, virtually or by telephone. We will aim to interview up to 10 participants in each arm, or until data saturation is reached. Interviews will be recorded using industry standard recording device/Dictaphone, transcribed, and data analysed under the guidance of the qualitative lead.
Recruitment and Retention
Time frame: At 18 months post enrolment
The site will be asked to keep a screening log of all patients identified, approached and given an information leaflet. The number of participants enrolled (defined as a participant providing written informed consent) and the proportion randomised will be reported. Reasons for screen failure and withdrawal will be collected and summarised in the CRF. Recruitment and retention will be periodically assessed in line with agreed targets with the funder.
2 secondary outcomes
Health Related Quality of Life Assessment
Time frame: At enrolment and 18 months
Healthcare Resource Utilisation
Time frame: At 18 months post enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Large Airway Collapse and Asthma, run by Liverpool School of Tropical Medicine 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 5 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Nightingale Dr Nightingale, PhD (+441517053100, rebecca.nightingale@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient acceptability (time frame: From Enrolment until 1 year). The study lists 2 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 14 Sep 2026.