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Evaluating the Safety and Feasibility of TLD for the Treatment of Severe Asthma | Clinical Trials | Clareo Health

TERMINATEDNA

Evaluating the Safety and Feasibility of TLD for the Treatment of Severe Asthma

A pRospective, Multicenter, Single-arm Study EvaLuating the Safety and feasIbility of Targeted Lung Denervation (TLD) for the trEatment oF Severe Asthma

NCT02872298•Nuvaira, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

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%;
+10 more criteria

Locations (9)

CHU de Grenoble

Grenoble, France

Thoraxklinik Heidelberg

Heidelberg, Germany

Academic Medical Center

Amsterdam, Netherlands

Universtity Medical Center Groningen

Groningen, Netherlands

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, United Kingdom

Key Dates

Start Date

December 22, 2017

Primary Completion Date

April 6, 2020

Completion Date

April 6, 2020

Last Updated

April 12, 2022

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

Targeted Lung Denervation (TLD)

DEVICE

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating the Safety and Feasibility of TLD for the Treatment of Severe Asthma

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma