Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma
- Registration Number
- NCT01103037
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Patients with moderate persistent asthma
Exclusion Criteria
- Smokers
- Any significant disease or illness, other than asthma
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QAV680 QAV680 - QAV680 Placebo QAV680 Placebo -
- Primary Outcome Measures
Name Time Method Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry 28 days
- Secondary Outcome Measures
Name Time Method Total serum IgE levels 28 days FEV1 assessments at various timepoints including time of peak drug concentration 28 days Measure the change in exhaled Nitric Oxide (FeNO) 28 days Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline. 28 days Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma. 28 days
Trial Locations
- Locations (4)
Novartis Investigative Site
🇷🇺Moscow, Russian Federation
American Health Research
🇺🇸Charlotte, North Carolina, United States
West Coast Clinical Trials
🇺🇸Cypress, California, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States