ARINA-1 for Non-cystic Fibrosis Bronchiectasis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Louisiana State University, New Orleans, LA
Non-cystic Fibrosis Bronchiectasis+1 More
ARINA-1 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Non-cystic Fibrosis Bronchiectasis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-cystic Fibrosis Bronchiectasis

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 56 days

56 days
Compare FEF25-75 between the ARINA-1 and treatment arms
Compare FEV1 between the ARINA-1 and treatment arms
Compare FVC between the ARINA-1 and treatment arms
Compare PEF between the ARINA-1 and treatment arms
Compare blood inflammatory markers between the ARINA-1 and placebo arms
Compare changes in airway clearance techniques between ARINA-1 and placebo arms
Compare changes in mucolytic use between ARINA-1 and placebo arms
Compare quality of life (as measured by CAAT questionnaire) between the ARINA-1 and placebo arms
Compare quality of life (as measured by QOL-B) between the ARINA-1 and placebo arms
Compare quality of life (as measured by SGRQ) between the ARINA-1 and placebo arms
Compare sputum percent solids between the ARINA-1 and placebo arms
Incidence of treatment-emergent adverse events
Proportion of participants that experience each treatment-emergent adverse event

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Non-cystic Fibrosis Bronchiectasis

Trial Design

2 Treatment Groups

ARINA-1
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: ARINA-1 · Has Placebo Group · Phase 2

ARINA-1
Drug
Experimental Group · 1 Intervention: ARINA-1 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 56 days
Closest Location: Louisiana State University · New Orleans, LA
Photo of New Orleans  1Photo of New Orleans  2Photo of New Orleans  3
2004First Recorded Clinical Trial
1 TrialsResearching Non-cystic Fibrosis Bronchiectasis
39 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of NCFBE confirmed by chest CT.
You have a stable airflow limitation for 90 days with any airway clearance technique (ACT) method(s).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.