Trial record 1 of 1 for:
RVN-301
Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05495243 |
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Recruitment Status :
Recruiting
First Posted : August 10, 2022
Last Update Posted : March 29, 2023
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Sponsor:
Renovion, Inc.
Information provided by (Responsible Party):
Renovion, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-cystic Fibrosis Bronchiectasis | Drug: ARINA-1 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ARINA-1 in Adult Participants With Non-CF Bronchiectasis (NCFBE) With Excess Mucus and Cough |
| Actual Study Start Date : | October 3, 2022 |
| Estimated Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | April 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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
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Drug: ARINA-1
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH) |
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Placebo Comparator: Placebo
Isotonic saline (0.9%); 4 mL solution inhaled twice daily via nebulization for 28 days
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Drug: Placebo
Isotonic saline (0.9%) |
Primary Outcome Measures :
- 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 Outcome Measures :
- Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms [ Time Frame: 56 days ]8 questions rated on a 0-5 scale
- Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms [ Time Frame: 56 days ]42 questions, ranked on a 5-point descriptive scale or true/false
- Compare quality of life (as measured by QOL-B) between the ARINA-1 and placebo arms [ Time Frame: 56 days ]37 questions ranked on a 4-point descriptive scale
- Compare blood inflammatory markers between the ARINA-1 and placebo arms [ Time Frame: 56 days ]C-reactive protein
- Compare changes in mucolytic use between ARINA-1 and placebo arms [ Time Frame: 56 days ]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.
- Compare changes in airway clearance techniques between ARINA-1 and placebo arms [ Time Frame: 56 days ]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.
- Compare FEV1 between the ARINA-1 and treatment arms [ Time Frame: 56 days ]measured in L
- Compare FVC between the ARINA-1 and treatment arms [ Time Frame: 56 days ]measured in L
- Compare FEF25-75 between the ARINA-1 and treatment arms [ Time Frame: 56 days ]measured in L/sec
- Compare PEF between the ARINA-1 and treatment arms [ Time Frame: 56 days ]measured in L/min
- Compare sputum percent solids between the ARINA-1 and placebo arms [ Time Frame: 56 days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of NCFBE confirmed by chest CT
- 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
Exclusion Criteria
- Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit
- Active exacerbation ≤14 days prior to the baseline visit
- Initiating or changing antibiotic, antiviral, or antifungal therapy ≤ 14 days prior to the baseline 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05495243
Contacts
| Contact: Carolyn Durham, PhD | 9192407034 | info@renovion.com |
Locations
| United States, Alabama | |
| University of Alabama - Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Heather Hathorne, PhD, RRT 205-638-9568 hyhathorne@uabmc.edu | |
| United States, Colorado | |
| National Jewish Hospital | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Charles Daley, MD 303-398-1667 daleyc@njhealth.org | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Amen Hamed 202-444-0895 amen.m.hamed@gunet.georgetown.edu | |
| United States, Louisiana | |
| Louisiana State University | Recruiting |
| New Orleans, Louisiana, United States, 70803 | |
| Contact: Olivia Rohret 504-568-2248 orohre@lsuhsc.edu | |
| United States, Maryland | |
| Johns Hopkins | Not yet recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Jan Nguyen 667-306-7509 j.nguyen@jhmi.edu | |
| United States, North Carolina | |
| Southeastern Research Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Karen McCutcheon kmccutcheon@southeasternresearchcenter.com | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Sarah Siegal 503-494-5496 siegals@ohsu.edu | |
| United States, Pennsylvania | |
| Jefferson Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Jeffrey Hoag, MD 215-503-9261 jeffrey.hoag@jefferson.edu | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Kim Spencer 843-792-6890 spenceal@musc.edu | |
| United States, Texas | |
| University of Texas - Tyler | Recruiting |
| Tyler, Texas, United States, 29425 | |
| Contact: Kimberly Greenlee 903-877-5986 kimberly.greenlee@uthct.edu | |
Sponsors and Collaborators
Renovion, Inc.
| Responsible Party: | Renovion, Inc. |
| ClinicalTrials.gov Identifier: | NCT05495243 |
| Other Study ID Numbers: |
RVN-301 |
| First Posted: | August 10, 2022 Key Record Dates |
| Last Update Posted: | March 29, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Renovion, Inc.:
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bronchiectasis |
Additional relevant MeSH terms:
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Bronchiectasis Bronchial Diseases Respiratory Tract Diseases |