Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma
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
1 other identifier
interventional
32
2 countries
5
Brief Summary
This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 17, 2007
CompletedFirst Posted
Study publicly available on registry
October 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedSeptember 2, 2010
September 1, 2010
1.1 years
October 17, 2007
September 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of omalizumab assessed by AEs and SAEs
Secondary Outcomes (1)
- Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels
Study Arms (3)
1
EXPERIMENTALOmalizumab 900 mg
2
EXPERIMENTALOmalizumab 1050 mg
3
EXPERIMENTALOmalizumab 1200 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Documented medical history of anaphylaxis
- Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
Novartis Investigative Site
Berlin, Germany
Novartis Investigative site
Hamburg, Germany
Novartis investigative site
Hanover, Germany
Novartis investigative site
Mainz, Germany
Novartis Investigative site
Bloemfontein, South Africa
Related Publications (1)
Kornmann O, Watz H, Fuhr R, Krug N, Erpenbeck VJ, Kaiser G. Omalizumab in patients with allergic (IgE-mediated) asthma and IgE/bodyweight combinations above those in the initially approved dosing table. Pulm Pharmacol Ther. 2014 Aug;28(2):149-53. doi: 10.1016/j.pupt.2014.03.003. Epub 2014 Mar 18.
PMID: 24657236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Novartis investigative site
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 17, 2007
First Posted
October 18, 2007
Study Start
July 1, 2007
Primary Completion
August 1, 2008
Last Updated
September 2, 2010
Record last verified: 2010-09