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

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    50
  • sponsor
    Renovion, Inc.
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Updated on 4 October 2022
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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.

Details
Condition Non-cystic Fibrosis Bronchiectasis
Treatment Placebo, ARINA-1
Clinical Study IdentifierNCT05495243
SponsorRenovion, Inc.
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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