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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AIN457

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

oral corticosteroid

Group Type ACTIVE_COMPARATOR

prednisolone

Intervention Type DRUG

Interventions

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AIN457

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

prednisolone

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes