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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00920933
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Biological: AIN457; Other: Placebo; Drug: prednisolone	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIN457	Biological: AIN457
Placebo Comparator: Placebo	Other: Placebo
Active Comparator: oral corticosteroid	Drug: prednisolone

Outcome Measures

Primary Outcome Measures

1. Total neutrophil cell count in 106/mL in induced sputum [Day 16]

Secondary Outcome Measures

1. Serum total IL-17A [Day 1- Day 120]

2. Percentage neutrophil cell count in induced sputum [Day 16]

3. Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs) [Day 1-Day 120]

4. Airway function (FEV1, FVC, and FEF25-75) [4h, 24h, and 48h after the start of the ozone exposure]

5. Serum AIN457 pharmacokinetics (PK) [Day1-Day 120]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Grosshansdorf		Germany

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00920933
• Other Study ID Numbers: CAIN457A2104; 2008-002854-39
• First Posted: Jun 15, 2009
• Last Update Posted: Apr 9, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Ozone challenge; airway neutrophilia; induced sputum; Healthy volunteers
• Additional relevant MeSH terms: Prednisolone

Study Results

No Results Posted as of Apr 9, 2010