Status:
COMPLETED
Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients
Lead Sponsor:
Novartis
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.'
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00814216
Start Date
December 1 2008
Last Update
March 8 2017
Active Locations (7)
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1
Novartis Investigative Site
Berlin, Germany
2
Novartis Investigative Site
Munich, Germany
3
Novartis Investigative Site
Wiesbaden, Germany
4
Novartis Investigative Site
Ahmedabad, India