Effect of AIN457 on Ozone-induced Airway Neutrophilia Com... | NCT00920933

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

NCT00920933

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 9, 2010Estimated

Enrollment

24Actual

Phase

Phase 1Phase 2

Conditions

Healthy

Interventions

AIN457
Placebo
prednisolone

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-002854-39

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Not provided

First Submitted Date

Jun 12, 2009

First Submission Date that Met QC Criteria

Jun 12, 2009

First Posted Date

Jun 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2010

Last Update Posted Date

Apr 9, 2010Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
AIN457	Experimental	Biological: AIN457
Placebo	Placebo Comparator	Other: Placebo
oral corticosteroid	Active Comparator	Drug: prednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AIN457	Biological		AIN457
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total neutrophil cell count in 106/mL in induced sputum		Day 16

Secondary Outcomes

Measure	Description	Time Frame
Serum total IL-17A		Day 1- Day 120
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Großhansdorf			Germany

Intervention Browse Module

MeSH Terms

ID	Term
C555450	secukinumab
D011239	Prednisolone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided