Safety and Efficacy Study of Omalizumab Given Prior to Im... | NCT00329381

Studies
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

NCT00329381

Sponsor

University of Mississippi Medical Center

Status

Completed

Last Update Posted

Jun 4, 2008Estimated

Enrollment

14Actual

Phase

Phase 4

Conditions

Asthma

Interventions

Xolair
Xolair

Countries

United States

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

Official Title

A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab)on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids

Status Module

Record Verification Date

Jan 2007

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

May 2006

Primary Completion Date

May 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

May 23, 2006

First Submission Date that Met QC Criteria

May 23, 2006

First Posted Date

May 24, 2006Estimated

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

Jun 3, 2008

Last Update Posted Date

Jun 4, 2008Estimated

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Detailed Description

Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.	Drug: Xolair
2	Experimental	Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.	Drug: Xolair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xolair	Drug	Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids		2005-2007

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis and history of moderate persistent allergic asthma
body weight >/= 20kg and </= 150kg
Total serum IgE >/= 30 and \

Accepts Healthy Volunteers

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
Gailen D. Marshall, MD/PhD	University of Mississippi Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Mississippi Medical Center		Jackson	Mississippi	39216	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069444	Omalizumab

Ancestor Terms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided