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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
Isotonic saline (0.9%)
University of Alabama - Birmingham
Birmingham, Alabama, United States
National Jewish Hospital
Denver, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Louisiana State University
New Orleans, Louisiana, United States
Johns Hopkins
Baltimore, Maryland, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Jefferson Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas - Tyler
Tyler, Texas, United States
Incidence of treatment-emergent adverse events
Incidence of participants that experience an adverse event following administration of treatment
Time frame: 56 days
Proportion of participants that experience each treatment-emergent adverse event
Time frame: 56 days
Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms
8 questions rated on a 0-5 scale
Time frame: 56 days
Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms
42 questions, ranked on a 5-point descriptive scale or true/false
Time frame: 56 days
Compare quality of life (as measured by QOL-B) between the ARINA-1 and placebo arms
37 questions ranked on a 4-point descriptive scale
Time frame: 56 days
Compare blood inflammatory markers between the ARINA-1 and placebo arms
C-reactive protein
Time frame: 56 days
Compare changes in mucolytic use between ARINA-1 and placebo arms
Compare the initiation or changes to regimen for drugs such as n-acetylcysteine, dornase alfa, etc. This information will be collected at all clinic visits and phone calls.
Time frame: 56 days
Compare changes in airway clearance techniques between ARINA-1 and placebo arms
Compare the initiation or changes to regimen for airway clearance techniques such as chest physical therapy, high-frequency oscillating vest therapy, etc. This information will be collected at all clinic visits and phone calls.
Time frame: 56 days
Compare FEV1 between the ARINA-1 and treatment arms
measured in L
Time frame: 56 days
Compare FVC between the ARINA-1 and treatment arms
measured in L
Time frame: 56 days
Compare FEF25-75 between the ARINA-1 and treatment arms
measured in L/sec
Time frame: 56 days
Compare PEF between the ARINA-1 and treatment arms
measured in L/min
Time frame: 56 days
Compare sputum percent solids between the ARINA-1 and placebo arms
Time frame: 56 days
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