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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546143
• Other study ID #: CIGE025A2208
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2007
• Last updated: September 1, 2010
• Start date: July 2007

Study information

• Verified date: September 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab

• Omalizumab

• Omalizumab

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative site	Hamburg
Germany	Novartis investigative site	Hannover
Germany	Novartis investigative site	Mainz
South Africa	Novartis Investigative site	Bloemfontein

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of omalizumab assessed by AEs and SAEs
Secondary	- Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels