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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Biological: AIN457; Drug: prednisolone

• Registration Number: NCT00920933
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Primary Completion: 2009-11
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-08
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AIN457	AIN457	-
oral corticosteroid	prednisolone	-

Primary Outcome Measures

Name	Time	Method
Total neutrophil cell count in 106/mL in induced sputum	Day 16

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Grosshansdorf, Germany