Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Royal Liverpool University Hospital | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of care for LACS. Which includes physio and good asthma management | |
| Intervention (CPAP) | Experimental | Nocturnal CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Nocturnal CPAP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptability |
| 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. | At 18 months post enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Nightingale Dr Nightingale, PhD | Contact | +441517053100 | rebecca.nightingale@lstmed.ac.uk | |
| Rachel Burton Dr Burton, MD | Contact | +441517053100 | rachel.burton@lstmed.ac.uk |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At enrolment and 18 months |
| Healthcare Resource Utilisation |
| At 18 months post enrolment |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |