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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARINA-1 | Experimental | 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 |
|
| Placebo | Placebo Comparator | Isotonic saline (0.9%); 4 mL solution inhaled twice daily via nebulization for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARINA-1 | Drug | ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Incidence of participants that experience an adverse event following administration of treatment | 56 days |
| Proportion of participants that experience each treatment-emergent adverse event | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms | 8 questions rated on a 0-5 scale | 56 days |
| Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Charles L Daley, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| National Jewish Hospital |
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| Placebo |
| Drug |
Isotonic saline (0.9%) |
|
42 questions, ranked on a 5-point descriptive scale or true/false
| 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 | 56 days |
| Compare blood inflammatory markers between the ARINA-1 and placebo arms | C-reactive protein | 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. | 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. | 56 days |
| Compare FEV1 between the ARINA-1 and treatment arms | measured in L | 56 days |
| Compare FVC between the ARINA-1 and treatment arms | measured in L | 56 days |
| Compare FEF25-75 between the ARINA-1 and treatment arms | measured in L/sec | 56 days |
| Compare PEF between the ARINA-1 and treatment arms | measured in L/min | 56 days |
| Compare sputum percent solids between the ARINA-1 and placebo arms | 56 days |
| Denver |
| Colorado |
| 80206 |
| United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Louisiana State University | New Orleans | Louisiana | 70803 | United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Jefferson Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas - Tyler | Tyler | Texas | 29425 | United States |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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