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Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough

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
Recruitment Status : Recruiting
First Posted : August 10, 2022
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Renovion, Inc.

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

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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
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
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
Drug: ARINA-1
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)

Placebo Comparator: Placebo
Isotonic saline (0.9%); 4 mL solution inhaled twice daily via nebulization for 28 days
Drug: Placebo
Isotonic saline (0.9%)




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 56 days ]
    Incidence of participants that experience an adverse event following administration of treatment

  2. Proportion of participants that experience each treatment-emergent adverse event [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Compare blood inflammatory markers between the ARINA-1 and placebo arms [ Time Frame: 56 days ]
    C-reactive protein

  5. 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.

  6. 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.

  7. Compare FEV1 between the ARINA-1 and treatment arms [ Time Frame: 56 days ]
    measured in L

  8. Compare FVC between the ARINA-1 and treatment arms [ Time Frame: 56 days ]
    measured in L

  9. Compare FEF25-75 between the ARINA-1 and treatment arms [ Time Frame: 56 days ]
    measured in L/sec

  10. Compare PEF between the ARINA-1 and treatment arms [ Time Frame: 56 days ]
    measured in L/min

  11. Compare sputum percent solids between the ARINA-1 and placebo arms [ Time Frame: 56 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Contact: Sarah Callahan 9192407034 sarah@renovion.com

Locations
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United States, Alabama
University of Alabama - Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Heather Hathorne, PhD, RRT    205-638-9568    hyhathorne@uabmc.edu   
United States, Colorado
National Jewish Hospital Not yet recruiting
Denver, Colorado, United States, 80206
Contact: Charles Daley, MD    303-398-1667    daleyc@njhealth.org   
United States, District of Columbia
Georgetown University Not yet 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, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Sarah Siegal    503-494-5496    siegals@ohsu.edu   
United States, Pennsylvania
Jefferson Hospital Not yet 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 Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Kim Spencer    843-792-6890    spenceal@musc.edu   
United States, Texas
University of Texas - Tyler Not yet recruiting
Tyler, Texas, United States, 29425
Contact: Kimberly Greenlee    903-877-5986    kimberly.greenlee@uthct.edu   
Sponsors and Collaborators
Renovion, Inc.
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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: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renovion, Inc.:
bronchiectasis
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases