Asthma Clinical Trial
— RELIEF-1Official title:
A pRospective, Multicenter, Single-arm Study EvaLuating the Safety and feasIbility of Targeted Lung Denervation (TLD) for the trEatment oF Severe Asthma
NCT number | NCT02872298 |
Other study ID # | D0384 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | December 22, 2017 |
Est. completion date | April 6, 2020 |
Verified date | April 2022 |
Source | Nuvaira, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma.
Status | Terminated |
Enrollment | 2 |
Est. completion date | April 6, 2020 |
Est. primary completion date | April 6, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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; - 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. Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Grenoble | Grenoble | |
Germany | Thoraxklinik Heidelberg | Heidelberg | |
Netherlands | Academic Medical Center | Amsterdam | |
Netherlands | Universtity Medical Center Groningen | Groningen | |
United Kingdom | Queen Elizabeth University Hospital | Glasgow | Scotland |
United Kingdom | Chelsea & Westminster Hospital NHS Foundation Trust | London | |
United Kingdom | Royal Brompton & Harefield NHS Foundation Trust | London | |
United Kingdom | NUH Nottingham City Hospital | Nottingham | |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton |
Lead Sponsor | Collaborator |
---|---|
Nuvaira, Inc. |
France, Germany, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of respiratory and non-respiratory adverse events | Rate of respiratory and non-respiratory adverse events | Through study completion, an average of 3 years | |
Other | Change in morning and evening peak expiratory flow (PEF) | Change in morning and evening peak expiratory flow (PEF) | Through 1 year follow-up | |
Other | Change in pre- and post-bronchodilator FEV1 | Change in pre- and post-bronchodilator FEV1 at pre-specified time points from baseline. | Through study completion, an average of 3 years | |
Other | Change in methacholine PC20 | Change in methacholine PC20 (provocation concentration causing a 20% fall in FEV1) at pre-specified time points from baseline. | Through 1 year follow-up | |
Other | Change in rescue medication usage | Change in rescue ("reliever") medication usage | Through study completion, an average of 3 years | |
Other | Number and level of asthma exacerbations | Number and level of asthma exacerbations | Through study completion, an average of 3 years | |
Other | Number of respiratory-related unscheduled physician office visits | Number of respiratory-related unscheduled physician office visits | Through study completion, an average of 3 years | |
Other | Number of emergency department visits | Number of emergency department visits | Through study completion, an average of 3 years | |
Other | Number of hospitalizations | Number of hospitalizations | Through study completion, an average of 3 years | |
Other | Change in inflammatory markers and bronchoscopic specimens | Analysis of inflammatory markers and bronchoscopic specimens collected at treatment and 90 days post-treatment. | 90 days | |
Other | Change in visual and quantitative lung attenuation via CT scan | CT assessment includes visual and quantitative lung attenuation statistics and texture analyses, airway morphometry, regional airflow and airway reactivity, air trapping and structural changes. | 1 Year | |
Other | Change in Cough | Changes in the Leicester Cough Questionnaire (LCQ) over time will be assessed. Comparisons will be made to baseline score. | Through study completion, an average of 3 years | |
Primary | 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. | 7 days, 1 month, 3 months, 6 months, and 12 months post-procedure | |
Secondary | 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. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | 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. | Through study completion, an average of 3 years | |
Secondary | Change in Asthma Control | Changes in the Asthma Control Questionnaire (ACQ) over time will be assessed. Comparisons will be made to baseline score. | Through study completion, an average of 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|