Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety and efficacy of ARINA-1 compared to placebo (isotonic saline, 0.9%) in participants with NCFBE. Study participants will receive either study treatment or placebo twice daily for 28 days. Efficacy endpoints will include quality of life, sputum rheological markers, and blood inflammatory markers. Quality of life will be measured using the following tools: Quality of Life-Bronchiectasis (QOL-B) questionnaire, St. George's Respiratory Questionnaire (SGRQ), Chronic Airways Assessment Test (CAAT), and a daily clinical global impression questionnaire.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Renovion, Inc.

Criteria

Inclusion Criteria:

• Diagnosis of NCFBE confirmed by chest CT

• BMI >18

• Percent predicted FEV1 > 40%, pre-bronchodilator

• Stable for 90 days with any airway clearance technique (ACT) method(s)

• Stable on standard of care (SOC) therapy for 90 days (includes cycling antibiotics, such as inhaled tobramycin, and long-term macrolide therapy) and not likely, in the opinion of the investigator, to require any changes to therapy during the duration of study participation

• Fully vaccinated for COVID-19 (second dose of a 2-shot regimen or single dose of 1-shot regimen completed >14 days prior to the screening visit)

• Must be able to produce a sputum sample

Exclusion Criteria

• Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit

• Active exacerbation ≤14 days prior to the baseline visit

• Initiating or changing antibiotic, antiviral, or antifungal therapy ≤ 14 days prior to the baseline visit

• Positive COVID-19 diagnostic test (PCR or antigen) within 90 days prior to the screening visit.

• Participated in other interventional drug or device studies within 30 days of the screening visit (Note: observational studies are acceptable)

• Significant unstable comorbidities (in the opinion of the site investigator), such as heart failure, cardiovascular disease, diabetes, renal disease, liver disease

• Current tobacco or marijuana smoker (those with active smoking exposure <180 days prior to the screening visit) (Note: edibles are acceptable)

• Requiring the use of any supplemental oxygen