NCT04973345

Terbutaline Sulfate in Adults With Asthma

A Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults With Asthma

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kanecia Obie Zimmerman · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Terbutaline	management of asthma symptoms

Timeline

• Start date: 2023-07-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-07-22
• Last updated: 2026-01-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study