Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
4 mL of 3% hypertonic saline
4 mL of 7% hypertonic saline
4 puffs (90 mcg/actuation)
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States
Change in MCC From Baseline to 7% Post Hypertonic Saline Inhalation
This outcome was the primary outcome maintained across the entire study (all cohorts). Smaller cohorts also examined the effect of 7% HS on MCC 4 hours after inhalation (Cohort 1), the effect of 3% HS on MCC immediate inhalation (Cohort 2), and the effect of albuterol alone on MCC (Cohort 3).
Time frame: Baseline MCC and at 2-12 weeks later MCC immediately after inhaled 7% HS, within approximately '15' minutes
Effects of Hypertonic Saline on MCC by Testing
The purpose of this outcome during Cohort 1 was to determine if there was a prolonged effect on MCC by 7% HS 4 hours post. Following interim analysis, it was decided that measurement at this timepoint would not be pursued and this outcome was deleted by a protocol amendment.
Time frame: Baseline MCC, and 1-6 weeks later (MCC scan administered 4 hours after 7% HS inhalation)
The Proportion of Moderate to Severe Asthmatics Who Are Deemed 'Intolerant' to Hypertonic Saline
A persistent reduction in the forced expiratory volume in one second (FEV1) of greater than or equal to 10% from that day's baseline
Time frame: 30 minutes post-Hypertonic Saline
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