drugset / Trial / NCT04195958

A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma

NCT04195958

Phase 4 Terminated 3 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor. The study will consist of a 4-week screening period, a 24-week treatment period, and a 4-week safety follow-up. Approximately 60 participants will be enrolled, and omalizumab will be dosed according to the approved United States Package Insert (USPI) dosing table.

Timeline

Start
2020-11-30
Primary completion
2021-10-18
Completion
2021-10-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 150 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 375 mg Subcutaneous

Indications