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Tracheostomy

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80,000

Tracheostomies performed annually

0

Therapies to clear mucus and decrease the impact of the procedure on the patient and also address associated challenges of a tracheostomy in the airway.

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ARINA·1 has been shown to decrease mucus viscosity and enable mucus clearance out of the lungs, as well as acting as a potent anti-inflammatory agent.  In patients with a tracheostomy, this impact has the potential to significantly improve quality of life and improve patient outcomes. 

Tracheostomy is a valuable clinical procedure in adults and children with both critical and chronic illness to bypass upper airway obstruction, facilitate chronic positive pressure ventilatory support, and to aid in the clearance of lower airway secretions. The presence of a tracheostomy adversely affects mucociliary clearance, impairs cough, and introduces a source of infection in the airways. Patients with a tracheostomy are faced with the recurring challenge of clearing mucus from the tracheostomy site as well as addressing mucus accumulation and chronic airway inflammation. Patients and caregivers face a myriad of challenges associated with sputum production and frequent and recurring pulmonary infections.  These symptoms lead to decreased quality of life and clinical decline. Currently, there are no FDA-approved therapies for mucus in people with a tracheostomy.

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Current Status

Investigator-Sponsored Clinical Study

Safety and Efficacy Study in Chronic Tracheostomy

Primary Endpoint:

Safety

 

Secondary Endpoints:

Quality of life, the impact of ARINA·1 on mucus rheology, bacterial growth, and systemic inflammatory markers

 

Duration:

28 days on therapy; 28 days off therapy

 

Trial Number:

NCT05658029

Patient Enrollment Status

Enrolling Now

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