Asthma Clinical Trial
Official title:
A Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults With Asthma
The overall aim in Part 1 is to compare the pharmacokinetic (PK)/pharmacodynamics (PD) relationship in intravenous (IV) versus subcutaneous (SQ) terbutaline sulfate to identify the optimal IV dosing range for use in Part 2. The overall aim in Part 2 is to evaluate the optimal IV dosing of terbutaline sulfate based on PD response and safety data.
Primary Objectives: 1. Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route. 2. Estimate a target plasma concentration and IV dose which achieves maximum FEV1 improvement from baseline and FEV1 AUC. Secondary Objective: Describe all adverse events (AEs) in participants receiving terbutaline sulfate. ;
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