A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ARINA-1 in Adult Participants With Non-cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough
Overview
- Phase
- Phase 2
- Intervention
- ARINA-1
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Sponsor
- Renovion, Inc.
- Enrollment
- 40
- Locations
- 10
- Primary Endpoint
- Incidence of treatment-emergent adverse events
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of NCFBE confirmed by chest CT
- •18-80 years old, inclusive at time of informed consent
- •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.
- •Exclusion Criteria
- •Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit
Exclusion Criteria
- Not provided
Arms & Interventions
ARINA-1
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization for 28 days
Intervention: ARINA-1
Placebo
Isotonic saline (0.9%); 4 mL solution inhaled twice daily via nebulization for 28 days
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events
Time Frame: 56 days
Incidence of participants that experience an adverse event following administration of treatment
Proportion of participants that experience each treatment-emergent adverse event
Time Frame: 56 days
Secondary Outcomes
- Compare changes in airway clearance techniques between ARINA-1 and placebo arms(56 days)
- Compare FEV1 between the ARINA-1 and treatment arms(56 days)
- Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms(56 days)
- Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms(56 days)
- Compare quality of life (as measured by QOL-B) between the ARINA-1 and placebo arms(56 days)
- Compare changes in mucolytic use between ARINA-1 and placebo arms(56 days)
- Compare blood inflammatory markers between the ARINA-1 and placebo arms(56 days)
- Compare FVC between the ARINA-1 and treatment arms(56 days)
- Compare FEF25-75 between the ARINA-1 and treatment arms(56 days)
- Compare PEF between the ARINA-1 and treatment arms(56 days)
- Compare sputum percent solids between the ARINA-1 and placebo arms(56 days)