Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'

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

Details

• Lead Sponsor: Novartis
• Treatments: Fluticasone; Xhance

Criteria

Inclusion criteria:

• Mild to moderate persistent asthma for at least 6 months.

Exclusion criteria:

• Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,

• Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc

• Surgical and/or medical conditions which significantly effect ADME of the drug.

• Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing

Other protocol-defined inclusion/exclusion criteria may apply