The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate asthma over a 4-week period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
RNS60, 4ml nebulized twice daily for 15 minutes.
RNS60, single 4 ml dose nebulized for 15 minutes
West Coast Clinical Trials
Cypress, California, United States
Stanford University
Stanford, California, United States
Forced expiratory volume in 1 second (FEV1)
Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by weekly FEV1 scores over 28 days.
Time frame: 28 days
Peak expiratory flow
Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by peak expiratory flow measured twice daily over 28 days.
Time frame: 28 days
Quality of life
Evidence that nebulized RNS60 does not cause a reduced quality of life in subjects with mild-to-moderate asthma, as measured a weekly quality of life questionnaire.
Time frame: 28 days
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