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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: June 12, 2009
Last updated: April 8, 2010
Last verified: April 2010
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.

Condition Intervention Phase
Healthy Biological: AIN457 Other: Placebo Drug: prednisolone Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Double Blind, Placebo Controlled, Parallel Group Study With an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Total neutrophil cell count in 106/mL in induced sputum [ Time Frame: Day 16 ]

Secondary Outcome Measures:
  • Serum total IL-17A [ Time Frame: Day 1- Day 120 ]
  • Percentage neutrophil cell count in induced sputum [ Time Frame: Day 16 ]
  • Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs) [ Time Frame: Day 1-Day 120 ]
  • Airway function (FEV1, FVC, and FEF25-75) [ Time Frame: 4h, 24h, and 48h after the start of the ozone exposure ]
  • Serum AIN457 pharmacokinetics (PK) [ Time Frame: Day1-Day 120 ]

Enrollment: 24
Study Start Date: January 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 Biological: AIN457
Placebo Comparator: Placebo Other: Placebo
Active Comparator: oral corticosteroid Drug: prednisolone


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00920933

Novartis Investigative Site
Grosshansdorf, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00920933     History of Changes
Other Study ID Numbers: CAIN457A2104
Study First Received: June 12, 2009
Last Updated: April 8, 2010

Keywords provided by Novartis:
Ozone challenge
airway neutrophilia
induced sputum
Healthy volunteers

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on June 23, 2017