What side effects are associated with this type of intervention?

Common treatments for Bronchiectasis that aim to reduce inflammation and improve sputum clearance, such as inhaled antibiotics and mucolytics, have several known side effects. Inhaled antibiotics like tobramycin can cause increased cough, dyspnea, wheezing, and noncardiac chest pain. Mucolytics, such as hypertonic saline, can lead to bronchial constriction and irritation. Inhaled aztreonam lysine may cause airway inflammation and requires a specific nebulizer for administration.

What prior FDA approvals exist?

The FDA has approved several treatments for bronchiectasis that focus on reducing inflammation and improving sputum clearance. Inhaled antibiotics like tobramycin and aztreonam lysine are commonly used to manage chronic Pseudomonas aeruginosa infections in bronchiectasis patients. These treatments help reduce bacterial load and inflammation, thereby improving lung function and quality of life. While ARINA-1 is still under investigation, its potential to reduce inflammation and improve sputum clearance aligns with the therapeutic goals of these approved treatments.

What other types of research exist?

Promising novel alternatives to ARINA-1 for Bronchiectasis patients in 2024 include: 1) Inhaled antibiotics like liposomal amikacin, which target bacterial infections and reduce inflammation. 2) Bronchodilators such as long-acting beta-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) to improve airway clearance. 3) Mucolytics like carbocysteine and N-acetylcysteine, which help in thinning mucus and improving sputum clearance. 4) Anti-inflammatory agents like macrolides (e.g., azithromycin) that have immunomodulatory effects. 5) Biologic therapies targeting specific inflammatory pathways, such as monoclonal antibodies against IL-5 or IL-13, which are under investigation for their potential benefits in bronchiectasis.

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Mucolytic Agent

ARINA-1 for Bronchiectasis

Phase 2

Waitlist Available

Led By Charles L Daley, MD

Research Sponsored by Renovion, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Summary

This trial tests ARINA-1, a new treatment for patients with NCFBE, a chronic lung condition. The goal is to see if it can improve their quality of life and reduce lung inflammation by giving the treatment regularly over a period of time.

Who is the study for?

This trial is for adults with non-CF bronchiectasis, able to cough up sputum, not currently smoking, and stable on their current lung treatments. They must have a certain level of lung function (FEV1 > 40%), be fully vaccinated against COVID-19, and can't be using supplemental oxygen or have had recent exacerbations or changes in medications.

What is being tested?

The study tests ARINA-1 versus a placebo saline solution over 28 days to see if it improves life quality and reduces mucus and inflammation in patients with non-CF bronchiectasis. Participants will receive the treatment twice daily, with outcomes measured by questionnaires and blood/sputum tests.

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to ARINA-1 or the placebo. These could include typical drug-related symptoms such as nausea, headaches, respiratory issues or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Compare FEF25-75 between the ARINA-1 and treatment arms

Therapeutic procedure

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ARINA-1Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ARINA-1

2022

Completed Phase 2

~40

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bronchiectasis include mucolytics, antibiotics, and bronchodilators. Mucolytics like N-acetylcysteine (NAC) work by breaking down mucus, making it easier to clear from the airways, which is crucial for preventing infections and maintaining lung function. Antibiotics target and reduce bacterial infections, which are common in Bronchiectasis and can exacerbate symptoms. Bronchodilators help to open the airways, improving airflow and facilitating mucus clearance. These treatments are essential for Bronchiectasis patients as they help manage chronic symptoms, reduce exacerbations, and improve overall quality of life by maintaining clearer airways and reducing inflammation.