Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough

Korábbi kezelés

• Active exacerbation ≤28 days prior to the baseline visit
• Initiating or changing antibiotic, antiviral, or antifungal therapy ≤ 28 days prior to the baseline visit
• Changing or initiating any vitamin C, glutathione or N-acetyl-cysteine-containing therapy or multivitamin within 30 says prior to the screening 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)
• Current tobacco or marijuana smoker (those with active smoking exposure \<180 days prior to the screening visit) (Note: edibles are acceptable)
• Currently on cycled antibiotics (e.g., tobramycin) or have been on a cycled antibiotic regimen within 90 days prior to the screening visit.
• Current diagnosis of non-tuberculous mycobacteria (NTM) requiring antibiotic treatment. (Participants who test positive for NTM but who are not currently on antibiotic therapy are eligible for screening)

Más betegség

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

Egyéb

• Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit
• Requiring the use of any supplemental oxygen

• Diagnosis of NCFBE confirmed by chest CT
• 18-80 years old, inclusive at time of informed consent
• 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
• If female and of childbearing potential, must be willing to use contraception for the duration of the study.