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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920933
First Posted: June 15, 2009
Last Update Posted: April 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920933


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

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00920933     History of Changes
Other Study ID Numbers: CAIN457A2104
2008-002854-39
First Submitted: June 12, 2009
First Posted: June 15, 2009
Last Update Posted: April 9, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents