The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
RNS60, 2ml, nebulized twice daily.
Normal Saline placebo, 2 ml, nebulized twice daily.
Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS.
West Coast Clinical Trials
Costa Mesa, California, United States
California Allergy and Asthma
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Integrated Research Group
Riverside, California, United States
Change in Forced expiratory volume in 1 second (FEV1)
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.
Time frame: Baseline to 56 days
Change in peak expiratory flow
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values.
Time frame: Baseline to 56 days
Change in quality of life
Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days.
Time frame: 56 days
Change in rescue inhaler usage
Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary.
Time frame: 56 days
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