NCT03556683

Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics.

Detailed description

Participants: Non-smoking adults with well controlled moderate to severe asthma Procedures (methods): After undergoing a general health screen, participants will undergo a lung transmission scan to create an image of the lungs. In subsequent visits, participants will inhale nebulized radiolabeled aerosol and sit in front of a gamma camera for 2 hours to measure clearance of radiolabeled particles from the lungs (procedure called gamma scintigraphy), which will be used to calculate baseline MCC. Spirometry will be performed before and at regular intervals after HS to assess for clinically significant reductions in lung function. Vital signs and symptom questionnaires will be administered as well. If participants are deemed tolerant to HS (i.e., no clinically significant deterioration in lung function, vital signs, or symptom questionnaire scores), participants will move forward with study visits.

Conditions

• Moderate to Severe Asthma

Interventions

Type	Name	Description
DEVICE	3% Hypertonic Saline	4 mL of 3% hypertonic saline
DEVICE	7% Hypertonic Saline	4 mL of 7% hypertonic saline
DRUG	Salbutamol	4 puffs (90 mcg/actuation)

Timeline

• Start date: 2018-10-01
• Primary completion: 2024-06-06
• Completion: 2024-06-06
• First posted: 2018-06-14
• Last updated: 2025-08-05
• Results posted: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study