NCT00590720

A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Effect on Exercise Challenge Testing of Multiple Fixed Subcutaneous Doses of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, in Adults With Stable Asthma and Exercise-Induced Bronchoconstriction

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	MEDI528 50 mg	MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
OTHER	PLACEBO	Placebo administered as a subcutaneous injection twice weekly for 4 weeks

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-12-01
• Completion: 2009-10-01
• First posted: 2008-01-11
• Last updated: 2014-03-21
• Results posted: 2014-03-21

Locations

12 sites across 2 countries: United States, Canada