Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects
- Registration Number
- NCT00920933
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - AIN457 AIN457 - oral corticosteroid prednisolone -
- Primary Outcome Measures
Name Time Method Total neutrophil cell count in 106/mL in induced sputum Day 16
- Secondary Outcome Measures
Name Time Method Serum total IL-17A Day 1- Day 120 Percentage neutrophil cell count in induced sputum Day 16 Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs) Day 1-Day 120 Airway function (FEV1, FVC, and FEF25-75) 4h, 24h, and 48h after the start of the ozone exposure Serum AIN457 pharmacokinetics (PK) Day1-Day 120
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Grosshansdorf, Germany