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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00920933
First received: June 12, 2009
Last updated: April 8, 2010
Last verified: April 2010
History of Changes
  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 Blind (Subject, 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:

MedlinePlus related topics: Ozone Steroids
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Total neutrophil cell count in 106/mL in induced sputum [ Time Frame: Day 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum total IL-17A [ Time Frame: Day 1- Day 120 ] [ Designated as safety issue: No ]
  • Percentage neutrophil cell count in induced sputum [ Time Frame: Day 16 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Airway function (FEV1, FVC, and FEF25-75) [ Time Frame: 4h, 24h, and 48h after the start of the ozone exposure ] [ Designated as safety issue: Yes ]
  • Serum AIN457 pharmacokinetics (PK) [ Time Frame: Day1-Day 120 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920933

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00920933     History of Changes
Other Study ID Numbers: CAIN457A2104, 2008-002854-39
Study First Received: June 12, 2009
Last Updated: April 8, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013