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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 is a Phase 2 study that has completed, run by Renovion. The registered enrollment target is 40 participants.
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.
Interventions
- DRUG Placebo
- DRUG ARINA-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05495243
The ClinicalTrials.gov registry entry for NCT05495243 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Renovion, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05495243 reports 0 study locations.
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.
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