Excessive Dynamic Airway CollapseEPOCNCT02763631
Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
A study testing Experimental: Treatment and Experimental: Run In Phase in people with Excessive Dynamic Airway Collapse and Tracheobronchomalacia, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess the benefit of a portable ventilator generating positive end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Excessive Dynamic Airway Collapse, Tracheobronchomalacia
- What is being tested?
- Experimental: Treatment and Experimental: Run In Phase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to 14 Jun 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with diagnosed EDAC or TBM on inspiratory/expiratory CT or bronchoscopy
- Patient with exertional dyspnea
Who cannot join
- Pregnancy
- Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
- Inability to perform 6-MWT
- Current intra-tracheal stent
- Previous surgery for EDAC or TBM
- Uncontrolled underlying disease:
- Initiation of home mechanical ventilation in last 3 months
- Uncontrolled joint pain
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the benefit of a portable ventilator generating positive end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM).
Read the detailed description
Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM) occur due to abnormal weakening of the walls of the central airways leading to central airway collapse on expiration. This collapse is responsible for breathlessness, cough or syncope. In adults, this weakening can be idiopathic (Mounier-Khun syndrome), secondary to respiratory diseases such as chronic obstructive pulmonary disease (COPD), secondary to systemic diseases such as relapsing polychondritis (RP) or secondary to invasive ventilation or trauma. The incidence of EDAC and TBM varies from 12% in all patients undergoing bronchoscopy to 44% in patients with chronic bronchitis undergoing bronchoscopy. Gold standard for the diagnosis of EDAC and TBM is bronchoscopy which identifies and quantifies the narrowing of the airway. Non-invasive technique such as inspiratory and expiratory chest computed-tomography (CT) can also be used to diagnose EDAC / TBM.
Currently, in addition to management of the underlying disease, treatment options for EDAC / TBM are limited. Surgical tracheoplasty can be offered but can be associated with severe post-operative complications. Airway stenting can also be offered but, even if this treatment improved quality of life, it fails to improve exercise capacity. Airway stenting is also associated with infectious complications as well as stent migrations. Other endoscopic treatment such as Yttrium Aluminium Perovskite laser can be offered with good results but have not yet been validated in a randomised trial. Nocturnal non-invasive ventilation (NIV) can also be used, especially in patients with associated obstructive sleep apnoeas but again there is not randomised clinical trial evidence that validates this approach in adults. Expiratory Positive Airway Pressure (EPAP) provides a pneumatic stenting that prevents the expiratory collapse of the airway. But, by giving the NIV during the night, patients are left without any support during the day whilst their respiratory demand is higher and when they are more symptomatic. Currently, NIV is only given at night or at rest because current non-invasive ventilators are not suitable for ambulatory use as they are heavy. Recently, a new portable ventilator with built-in battery has been issued (Z1®, Breas®). This ventilator is light (500g) portable and has a working duration of 8 hours. Therefore, it can be easily carried and used while walking. By providing a nasal pillow interface (Nasal swift®, Resmed®) to patients, it will allow them to walk safely with the device on.
- Being tested
- Experimental: Treatment, Experimental: Run In Phase, Sham Comparator: Stand Care Arm
- Medical subject headings
- Tracheobronchomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: TreatmentOther
Participants will be established on portable CPAP during the day with nasal pillows as an interface and requested to use it at least 8 hours/day.
Experimental: Run In PhaseOther
Participants will undergo a run-in phase during which they will undergo baseline assessments. If they tolerate the portable CPAP and if their 6-MWT improves by more than 30m when performed on CPAP, they will be randomised into the trial.
Sham Comparator: Stand Care ArmOther
No change will be made to participants care
| Study group | Role | What they receive |
|---|---|---|
| Run In Phase | Experimental | Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP Receives: Other: Experimental: Run In Phase |
| Treatment | Experimental | Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either:
Treatment arm - Patients will be setup onto portable CPAP during the day Receives: Other: Experimental: Treatment |
| Standard Care Arm | Sham comparator | Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either:
Control Arm - Standard care arm. Receives: Other: Sham Comparator: Stand Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does daytime activity by an accelerometer change from baseline to 4 weeks
Daytime activity assessed by an accelerometer. Participants will be assessed at baseline and at 4 weeks in the control arm and in the treatment arm with participants on portable CPAP to see if there is any change between the time frames and between the groups on daytime activity measured by accelerometers that all participants randomised into the trial will wear from baseline to follow up at 4 weeks.
Measured: 4 weeks
Secondary outcomes (6)
Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up
Is there a change in exercise capacity measured by 6-MWT for all patients in the study from baseline to 4 weeks. All walk tests will be performed on portable Continuous Positive Airway Pressure (CPAP)
Measured: 4 weeks
Change in respiratory-related quality of life - Severe Respiratory Insufficiency (SRI)
Is there a change in quality of life from baseline to 4 weeks measured by Severe Respiratory Insufficiency Questionnaire
Measured: 4 weeks
Change in respiratory-related quality of life - St George's Respiratory Questionnaire (SGRQ)
Is there a change in quality of life from baseline to 4 weeks measured by St George's Respiratory Questionnaire.
Measured: 4 weeks
Change in neural respiratory drive with parasternal electromyography
Is there a change in neural respiratory drive measured by parasternal electromyography both at rest and whilst using portable CPAP at baseline and at 4 weeks
Measured: 4 weeks
Change of lung homogeneity assessed by electrical impedance tomography while on CPAP
Is there a change in lung homogeneity in participants from baseline to 4 weeks. Measured by electrical impedence tomography whilst all participants are using portable CPAP
Measured: 4 weeks
Change in cross-sectional area quadriceps rectus femoris ultra-sound
Is there a change in the area of the quadriceps rectus femoris in participants from baseline to 4 weeks. Measured using ultrasound which will be performed on all participants
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startSep 2016
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Dynamic Airway CollapseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- B&D Electromedical
- Responsible party
- Sponsor
- Investigators
- Nick Hart, Study chair, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763631
- Sponsor's protocol ID
- 16/LO/0028
- Acronym
- EPOC
- Status last verified
- May 2018
- First submitted
- 4 May 2016
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT02763631
- Acronym / sponsor ID
- EPOC / 16/LO/0028
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- B&D Electromedical
- Study start
- Sep 2016
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- 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 aim of this study is to assess the benefit of a portable ventilator generating positive end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM).
Detailed description
Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM) occur due to abnormal weakening of the walls of the central airways leading to central airway collapse on expiration. This collapse is responsible for breathlessness, cough or syncope. In adults, this weakening can be idiopathic (Mounier-Khun syndrome), secondary to respiratory diseases such as chronic obstructive pulmonary disease (COPD), secondary to systemic diseases such as relapsing polychondritis (RP) or secondary to invasive ventilation or trauma. The incidence of EDAC and TBM varies from 12% in all patients undergoing bronchoscopy to 44% in patients with chronic bronchitis undergoing bronchoscopy. Gold standard for the diagnosis of EDAC and TBM is bronchoscopy which identifies and quantifies the narrowing of the airway. Non-invasive technique such as inspiratory and expiratory chest computed-tomography (CT) can also be used to diagnose EDAC / TBM.
Currently, in addition to management of the underlying disease, treatment options for EDAC / TBM are limited. Surgical tracheoplasty can be offered but can be associated with severe post-operative complications. Airway stenting can also be offered but, even if this treatment improved quality of life, it fails to improve exercise capacity. Airway stenting is also associated with infectious complications as well as stent migrations. Other endoscopic treatment such as Yttrium Aluminium Perovskite laser can be offered with good results but have not yet been validated in a randomised trial. Nocturnal non-invasive ventilation (NIV) can also be used, especially in patients with associated obstructive sleep apnoeas but again there is not randomised clinical trial evidence that validates this approach in adults. Expiratory Positive Airway Pressure (EPAP) provides a pneumatic stenting that prevents the expiratory collapse of the airway. But, by giving the NIV during the night, patients are left without any support during the day whilst their respiratory demand is higher and when they are more symptomatic. Currently, NIV is only given at night or at rest because current non-invasive ventilators are not suitable for ambulatory use as they are heavy. Recently, a new portable ventilator with built-in battery has been issued (Z1®, Breas®). This ventilator is light (500g) portable and has a working duration of 8 hours. Therefore, it can be easily carried and used while walking. By providing a nasal pillow interface (Nasal swift®, Resmed®) to patients, it will allow them to walk safely with the device on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Run In Phase | Experimental | Other: Experimental: Run In PhaseEligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP |
| Treatment | Experimental | Other: Experimental: TreatmentThose patients who improve their 6-MWT by more than 30 meters will then be randomised to either: Treatment arm - Patients will be setup onto portable CPAP during the day |
| Standard Care Arm | Sham comparator | Other: Sham Comparator: Stand Care ArmThose patients who improve their 6-MWT by more than 30 meters will then be randomised to either: Control Arm - Standard care arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with diagnosed EDAC or TBM on inspiratory/expiratory CT or bronchoscopy
- Patient with exertional dyspnea
Key exclusion criteria (8 listed)
- Pregnancy
- Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
- Inability to perform 6-MWT
- Current intra-tracheal stent
- Previous surgery for EDAC or TBM
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 |
|---|---|---|
| Experimental: TreatmentParticipants will be established on portable CPAP during the day with nasal pillows as an interface and requested to use it at least 8 hours/day. | Other | Treatment |
| Experimental: Run In PhaseParticipants will undergo a run-in phase during which they will undergo baseline assessments. If they tolerate the portable CPAP and if their 6-MWT improves by more than 30m when performed on CPAP, they will be randomised into the trial. | Other | Run In Phase |
| Sham Comparator: Stand Care ArmNo change will be made to participants care | Other | Standard Care Arm |
Primary outcome
Does daytime activity by an accelerometer change from baseline to 4 weeks
Time frame: 4 weeks
Daytime activity assessed by an accelerometer. Participants will be assessed at baseline and at 4 weeks in the control arm and in the treatment arm with participants on portable CPAP to see if there is any change between the time frames and between the groups on daytime activity measured by accelerometers that all participants randomised into the trial will wear from baseline to follow up at 4 weeks.
6 secondary outcomes
Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up
Time frame: 4 weeks
Change in respiratory-related quality of life - Severe Respiratory Insufficiency (SRI)
Time frame: 4 weeks
Change in respiratory-related quality of life - St George's Respiratory Questionnaire (SGRQ)
Time frame: 4 weeks
Change in neural respiratory drive with parasternal electromyography
Time frame: 4 weeks
Change of lung homogeneity assessed by electrical impedance tomography while on CPAP
Time frame: 4 weeks
Change in cross-sectional area quadriceps rectus femoris ultra-sound
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: No
Related trials for Excessive Dynamic Airway Collapse
Recruiting
Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
Tracheobronchomalacia, Excessive Dynamic Airway Collapse
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.
Nick Hart study chair
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Treatment and Experimental: Run In Phase in people with Excessive Dynamic Airway Collapse and Tracheobronchomalacia, run by Guy's and St Thomas' NHS Foundation Trust 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 8 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: finished, as of the sponsor's last update on 29 May 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does daytime activity by an accelerometer change from baseline to 4 weeks (time frame: 4 weeks). 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 29 May 2018.