Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

• Status: Terminated
• Trial end date: 2016-03-22
• Target enrollment: 0
• Participant gender: All

Summary

This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• forced Expiratory Volume in one second ( FEV1) >= 40% predicted

• patients who completed CQGE031B2201 study

Key Exclusion Criteria:

• life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study

• new malignancy

• ongoing SAE from CQGE031B2201 that was assessed as related to study drug

• patient experienced platelets drop to < 75,000/uL

• patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions

• patient is pregnant