Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Biological: AIN457; Other: Placebo; Drug: prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920933

2008-002854-39

CAIN457A2104

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

AIN457

Experimental group

Treatment:

Biological: AIN457

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

oral corticosteroid

Active Comparator group

Treatment:

Drug: prednisolone