Evaluating the Safety and Feasibility of TLD for the Treatment of Moderate to Severe Refractory Asthma

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 30
• Participant gender: Both

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Holaira
• Treatments: Glucocorticoids; Prednisone; Tiotropium Bromide
• Last Updated: 2016-09-22

Criteria

Inclusion Criteria:

• Patient has provided written informed consent

• Diagnosis of asthma and is taking regular maintenance medication as specified in the study protocol

• Pre-bronchodilator FEV1 ≥60% predicted after a 4 week medication run-in of a glucocorticoid (≥800 budesonide or equivalent) + Long Acting Beta-Agonist (LABA) therapy

• Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period

• Stable asthma during the past 6 weeks as defined in study protocol

• 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 1 year

• 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:

• ≥ 3 lower respiratory tract infections requiring antibiotics during previous 12 months or respiratory tract infection within the previous 6 weeks

• Subject has 3 or more hospitalizations for asthma exacerbation in the past year OR a history of life-threatening asthma, as defined in study protocol

• Exacerbation ≤ 6 weeks prior to enrollment

• Steroid burst ≤ 6 weeks from enrollment or use of oral steroids at the time of enrollment

• Known sensitivity or contraindication to bronchoprovocation testing per standard guidelines

• 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 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%

• Treated with immunosuppressant therapy within the last 2 years

• Patient has an implantable electronic device

• Known hypersensitivity to anticholinergic drugs or components

• Known allergy to medications required for bronchoscopy or general anesthesia

• 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

• 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

• Recent (<3 months ago) narcotic use

• Patient is currently enrolled in another clinical trial that has not completed follow-up