This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
59
WCCT Global
Costa Mesa, California, United States
Allied Clinical Research
Gold River, California, United States
Allied Clinical Research
Reno, Nevada, United States
Dr. Winder & Associates/Toledo Center for Clinical Research
Sylvania, Ohio, United States
Change from baseline in FEV1
Time frame: After 2 weeks of treatment with TRN-157 vs. Placebo
Safety and tolerability as determined by number of subjects with adverse events
Adverse events and/or clinically significant changes in vital signs, ECG, and/or laboratory values
Time frame: After 2 weeks of treatment with TRN-157 vs. Placebo
Characterize effects on pulmonary function
FEV1(0-4 h); FVC AUC(0-4 h); FVC(0-4 h); Morning PEFR; Trough (pre-dose) FEV1
Time frame: After 2 weeks of treatment with TRN-157 vs. Placebo
Characterize effects on asthma symptomatology
Asthma symptoms, including exacerbations; Number of asthma-control days; Rescue inhaler use; Nocturnal symptoms
Time frame: During the 2 weeks of treatment with TRN-157 vs. Placebo
Determination of pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, tmax, t½, elimination rate constant (kel), volume of distribution at steady state (Vss/F), total plasma clearance (CL/F)
AUC0-t, AUC0-inf, Cmax, tmax, t½, elimination rate constant (kel), volume of distribution at steady state (Vss/F), total plasma clearance (CL/F)
Time frame: After 2 weeks of treatment with TRN-157
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The Allergy and Asthma Center of Southern Oregon
Medford, Oregon, United States
West Houston Clinical Research Services
Houston, Texas, United States
Sylvana Research
San Antonio, Texas, United States