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Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00546143
Collaborator
(none)
32
Enrollment
5
Locations
3
Arms
6.4
Patients Per Site

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-center, Open-label, Multiple Dose Study in Mild to Moderate Asthmatics (With IgE/Body Weight Combinations Above That in the SmPC Dosing Table) to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Omalizumab
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Omalizumab 900 mg

Drug: Omalizumab
Other Names:
  • Xolair, IGE025

    		•
    Experimental: 2

    Omalizumab 1050 mg

    Drug: Omalizumab
    Other Names:
  • Xolair, IGE025

    		•
    Experimental: 3

    Omalizumab 1200 mg

    Drug: Omalizumab
    Other Names:
  • Xolair, IGE025

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of omalizumab assessed by AEs and SAEs []

    Secondary Outcome Measures

    1. - Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of allergic asthma >= 1 year duration and a history consistent with Step 2 or 3 clinical features from the Global Initiative for Asthma guidelines.

    • Eligible baseline serum immunoglobulin E (IgE) levels value and body-weight combinations

    Exclusion Criteria:

    • Documented medical history of anaphylaxis

    • Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD)

    Other protocol-defined inclusion/exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Berlin Germany
    2 Novartis Investigative site Hamburg Germany
    3 Novartis investigative site Hannover Germany
    4 Novartis investigative site Mainz Germany
    5 Novartis Investigative site Bloemfontein South Africa

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Principal Investigator: Novartis, Novartis investigative site

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00546143
    Other Study ID Numbers:
    • CIGE025A2208
    First Posted:
    Oct 18, 2007
    Last Update Posted:
    Sep 2, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Asthma, anti-immunoglobulin E, omalizumab
    Additional relevant MeSH terms:
    Asthma
    Omalizumab
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Sep 2, 2010