AsthmaRELIEF-1NCT02872298
Evaluating the Safety and Feasibility of TLD for the Treatment of Severe Asthma
A study testing Targeted Lung Denervation (TLD) in people with Asthma, run by Nuvaira, Inc. at 9 sites in 4 countries.
Trial summary
Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Targeted Lung Denervation (TLD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 22 Dec 2017to 6 Apr 2020
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has provided written informed consent;
- Diagnosis of severe asthma as defined by the 2018 GINA Report, and are taking regular maintenance medication as specified in the study protocol;
- Pre-bronchodilator FEV1 ≥50% predicted after a 4 week medication run-in;
- Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period;
- Women of child bearing potential must have a negative pregnancy test and agree not to become pregnant for the duration during the study;
- Non-smoker for at least 6 months and agree to continue not smoking for duration of the study;
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- Patient is a candidate for bronchoscopy in the opinion of the physician or per hospital guidelines;
- Patient is a candidate to undergo methacholine challenge testing;
- Patient is willing, able and agrees to complete all protocol required baseline and follow up testing and comply with medication requirements.
Who cannot join
- In the 24 months prior to enrollment, the subject has: been intubated for asthma, had intensive care unit (ICU) admission(s) for asthma, or been treated with immunosuppressant therapy for any reason (steroids excluded);
- In the 12 months prior to enrollment, the subject has had: ≥4 lower respiratory tract infections requiring antibiotics or ≥4 hospitalizations for asthma exacerbations;
- In the 3 months prior to enrollment, the subject has taken/used an opioid(s);
- In the 6 weeks prior to enrollment the subject has had a lower respiratory tract infection or asthma exacerbation that required: antibiotics, unscheduled physician visits for asthma care, changes in use of asthma maintenance medication, taking of rescue medication over normal dose in a 24-hour period for asthma symptoms and a steroid burst (pulse);
- Current use of greater than 10 mg of oral steroids per day at the time of enrollment;
- History of poor medication compliance;
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- Prior lung or chest procedure;
- Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal chord dysfunction, eosinophilic granulomatosis with polyangiitis (EGPA) or interstitial lung disease that is the sole cause of asthma symptoms, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways;
- Pre-existing diagnosis of pulmonary hypertension as defined in the study protocol;
- Uncontrolled diabetes as evidenced by an HbA1c > 7%;
- Patient has an implantable electronic device;
- Known contraindication or allergy to anticholinergic drugs or components;
- Known contraindication of allergy to medications required for bronchoscopy, general anesthesia or peri-procedural therapy that cannot be medically controlled;
- Patient is unable to stop blood thinning medication for 7 days prior and 7 days after procedure;
- Documented history of untreated severe obstructive sleep apnea;
- Patient has any disease or condition that might interfere with completion of a procedure or this study or patient safety;
- Screening chest CT scan reveals bronchi anatomy cannot be fully treated with the available catheter sizes or discovery of a pulmonary nodule requiring follow-up or intervention unless proven benign;
- Patients who had abdominal surgical procedures on stomach, esophagus or pancreas;
- Patients with a Gastroparesis Cardinal Symptom Index (GCSI) score ≥ 18 prior to treatment;
- Patient is currently enrolled in another clinical trial that has not completed follow-up.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United Kingdom5 sites
Queen Elizabeth University Hospital
Glasgow, Scotland
Chelsea & Westminster Hospital NHS Foundation Trust
London
Royal Brompton & Harefield NHS Foundation Trust
London
NUH Nottingham City Hospital
Nottingham
University Hospital Southampton NHS Foundation Trust
Southampton
Netherlands2 sites
Academic Medical Center
Amsterdam
Universtity Medical Center Groningen
Groningen
About this study
Official title: A pRospective, Multicenter, Single-arm Study EvaLuating the Safety and feasIbility of Targeted Lung Denervation (TLD) for the trEatment oF Severe Asthma
Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma.
Read the detailed description
Prospective, multicenter, single-arm (non-randomized) study. All patients will undergo a run in period on optimal medical therapy as part of eligibility testing. Final determination to initiate treatment will be made after initial airway inspection. A total of 20 patients will be treated. Inflammatory biomarkers (washes and brushes) will be collected in all patients and bronchial biopsies will be collected from the last 10 patients at the time of treatment and at 90-days post-treatment. All patients will be prescribed peri-procedural antibiotics and steroids to minimize procedural risks. All patients will be provided a mobile handheld spirometer to measure and record daily peak expiratory flow both before and after treatment to monitor lung function. Patient follow-up will be conducted out to 3 years.
- Conditions
- Asthma
- Being tested
- Targeted Lung Denervation (TLD)
- Keywords
- Severe, Refractory
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Lung Denervation (TLD)Device
The Nuvaira Lung Denervation System, manufactured by Nuvaira, Inc., is intended to deliver TLD Therapy using predetermined radiofrequency (RF) energy over a predetermined period of time to ablate airway nerve trunks which are located on the outside of the main bronchi.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment: Targeted Lung Denervation (TLD) Receives: Device: Targeted Lung Denervation (TLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device related therapeutic interventions
Number and % of patients free from device related therapeutic interventions will be reported. Therapeutic intervention is defined as administration of non-protocol required antibiotics or steroids, an endoscopic procedure or surgery to treat findings and/or conduction of another diagnostic test to assess the treatment area due to safety concerns.
Measured: 7 days, 1 month, 3 months, 6 months, and 12 months post-procedure
Secondary outcomes (4)
Device Success
Number and % of subjects with reported Device Success, defined as the ability to insert and place the dNerva Catheter to its intended locations and intact removal.
Measured: 1 day
Technical Success
Number and % of subjects with reported Technical Success, defined as device success with the ability to deliver RF energy to each intended location as confirmed by the Nuvaira Console.
Measured: 1 day
Change in Quality of Life (QOL)
Changes in the Asthma Quality of Life Questionnaire (AQLQ) over time will be assessed. Comparisons will be made to baseline score.
Measured: Through study completion, an average of 3 years
Change in Asthma Control
Changes in the Asthma Control Questionnaire (ACQ) over time will be assessed. Comparisons will be made to baseline score.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start22 Dec 2017
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvaira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nick ten Hacken, MD, Principal investigator, University Medical Center Groningen (UMCG)Pallav Shah, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872298
- Sponsor's protocol ID
- D0384
- Acronym
- RELIEF-1
- Status last verified
- Apr 2022
- First submitted
- 5 Aug 2016
- Last updated
- 12 Apr 2022
- 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 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A pRospective, Multicenter, Single-arm Study EvaLuating the Safety and feasIbility of Targeted Lung Denervation (TLD) for the trEatment oF Severe Asthma
- ClinicalTrials.gov ID
- NCT02872298
- Acronym / sponsor ID
- RELIEF-1 / D0384
- Conditions
- Asthma
- Keywords
- Severe, Refractory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nuvaira, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 19 Aug 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.
Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma.
Detailed description
Prospective, multicenter, single-arm (non-randomized) study. All patients will undergo a run in period on optimal medical therapy as part of eligibility testing. Final determination to initiate treatment will be made after initial airway inspection. A total of 20 patients will be treated. Inflammatory biomarkers (washes and brushes) will be collected in all patients and bronchial biopsies will be collected from the last 10 patients at the time of treatment and at 90-days post-treatment. All patients will be prescribed peri-procedural antibiotics and steroids to minimize procedural risks. All patients will be provided a mobile handheld spirometer to measure and record daily peak expiratory flow both before and after treatment to monitor lung function. Patient follow-up will be conducted out to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Targeted Lung Denervation (TLD)Treatment: Targeted Lung Denervation (TLD) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has provided written informed consent;
- Diagnosis of severe asthma as defined by the 2018 GINA Report, and are taking regular maintenance medication as specified in the study protocol;
- Pre-bronchodilator FEV1 ≥50% predicted after a 4 week medication run-in;
- Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period;
- Women of child bearing potential must have a negative pregnancy test and agree not to become pregnant for the duration during the study;
Key exclusion criteria (20 listed)
- In the 24 months prior to enrollment, the subject has: been intubated for asthma, had intensive care unit (ICU) admission(s) for asthma, or been treated with immunosuppressant therapy for any reason (steroids excluded);
- In the 12 months prior to enrollment, the subject has had: ≥4 lower respiratory tract infections requiring antibiotics or ≥4 hospitalizations for asthma exacerbations;
- In the 3 months prior to enrollment, the subject has taken/used an opioid(s);
- In the 6 weeks prior to enrollment the subject has had a lower respiratory tract infection or asthma exacerbation that required: antibiotics, unscheduled physician visits for asthma care, changes in use of asthma maintenance medication, taking of rescue medication over normal dose in a 24-hour period for asthma symptoms and a steroid burst (pulse);
- Current use of greater than 10 mg of oral steroids per day at the time of enrollment;
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 |
|---|---|---|
| Targeted Lung Denervation (TLD)The Nuvaira Lung Denervation System, manufactured by Nuvaira, Inc., is intended to deliver TLD Therapy using predetermined radiofrequency (RF) energy over a predetermined period of time to ablate airway nerve trunks which are located on the outside of the main bronchi. | Device | Treatment |
Primary outcome
Freedom from device related therapeutic interventions
Time frame: 7 days, 1 month, 3 months, 6 months, and 12 months post-procedure
Number and % of patients free from device related therapeutic interventions will be reported. Therapeutic intervention is defined as administration of non-protocol required antibiotics or steroids, an endoscopic procedure or surgery to treat findings and/or conduction of another diagnostic test to assess the treatment area due to safety concerns.
4 secondary outcomes
Device Success
Time frame: 1 day
Technical Success
Time frame: 1 day
Change in Quality of Life (QOL)
Time frame: Through study completion, an average of 3 years
Change in Asthma Control
Time frame: Through study completion, an average of 3 years
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Nick ten Hacken, MD principal investigator
University Medical Center Groningen (UMCG)
Pallav Shah, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Lung Denervation (TLD) in people with Asthma, run by Nuvaira, Inc. at 9 sites in 4 countries.
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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Netherlands, France, Germany. 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?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Freedom from device related therapeutic interventions (time frame: 7 days, 1 month, 3 months, 6 months, and 12 months post-procedure). 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 12 Apr 2022.