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NCT05495243 · ClinicalTrials.gov registry record · Phase 2

Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough

A Phase 2 study, sponsored by Renovion.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT05495243: Completed Phase 2 study, sponsored by Renovion.

NCT05495243 is a Phase 2 study that has completed, run by Renovion. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05495243, a Phase 2 study, has completed, sponsored by Renovion.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study 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.

Primary Outcome

Incidence of participants that experience an adverse event following administration of treatment

Interventions

  • DRUG Placebo
  • DRUG ARINA-1

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2022-10-03
Est. Completion 2024-02-01
Phase Phase 2
Renovion

2 total trials

What the finished NCT05495243 record still lists

NCT05495243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05495243 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05495243 about?

NCT05495243 is a clinical study titled "Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough". 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 ...

What is the current status of trial NCT05495243?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-10-03. Estimated completion is 2024-02-01.

What interventions are being tested in trial NCT05495243?

The interventions under investigation include: Placebo (DRUG), ARINA-1 (DRUG).

Who is sponsoring clinical trial NCT05495243?

This trial is sponsored by Renovion, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05495243's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05495243, the US trial registry maintained by the National Library of Medicine. NCT05495243 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.