Status:
COMPLETED
Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
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 corti...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy subjects
- Normal sputum neutrophil levels at screening
- Ozone responsive
- Exclusion criteria:
- Smokers
- Prior treatment with antibody treatment or immunosuppressive agent
- Presence or history of a major chronic inflammatory autoimmune disease
- History of severe hypersensitivity to any biological agents (antibody or soluble receptor), a history of serious allergic reaction, collagen disease, neurological disease (including demyelinating disease).
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00920933
Start Date
January 1 2009
Last Update
April 9 2010
Active Locations (1)
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1
Novartis Investigative Site
Großhansdorf, Germany