Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Renovion, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit
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)
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
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)
Clareo Health | Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough
