NCT02872298

Brief Summary

Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable asthma

Geographic Reach
4 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 22, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2020

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

August 5, 2016

Last Update Submit

April 4, 2022

Conditions

Asthma

Keywords

SevereRefractory

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Device Success

    1 day

  • Technical Success

    1 day

  • Change in Quality of Life (QOL)

    Through study completion, an average of 3 years

  • Change in Asthma Control

    Through study completion, an average of 3 years

Other Outcomes (12)

  • Rate of respiratory and non-respiratory adverse events

    Through study completion, an average of 3 years

  • Change in morning and evening peak expiratory flow (PEF)

    Through 1 year follow-up

  • Change in pre- and post-bronchodilator FEV1

    Through study completion, an average of 3 years

  • +9 more other outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment: Targeted Lung Denervation (TLD)

Device: Targeted Lung Denervation (TLD)

Interventions

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.

Treatment

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU de Grenoble

Grenoble, France

Location

Thoraxklinik Heidelberg

Heidelberg, Germany

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Universtity Medical Center Groningen

Groningen, Netherlands

Location

Queen Elizabeth University Hospital

Glasgow, Scotland, United Kingdom

Location

Chelsea & Westminster Hospital NHS Foundation Trust

London, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Location

NUH Nottingham City Hospital

Nottingham, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

MeSH Terms

Conditions

AsthmaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative Disorders

Study Officials

  • Nick ten Hacken, MD

    University Medical Center Groningen (UMCG)

    PRINCIPAL INVESTIGATOR

  • Pallav Shah, MD

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 19, 2016

Study Start

December 22, 2017

Primary Completion

April 6, 2020

Study Completion

April 6, 2020

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)GB(5)DE(1)FR(1)