A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels

Asthma Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy of Xolair in an Allergen Bronchoprovocation Study in Asthmatic Populations Defined by Serum IgE Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624832
• Other study ID #: CIGE025A2210
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2008
• Last updated: April 12, 2011
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female adult patients, body weight between 40-150 kg aged 18-65 years (inclusive)

• Patients diagnosed with asthma with Forced Expiratory Volume (FEV1) =65% of the predicted normal value for the patient

• Positive skin prick test to a specific allergen

• Patients had to demonstrate a Provocative Dose 20% FEV1 decline (PD20) response to an aeroallergen in the graded allergen bronchoprovocation testing (ABP) at screening

Exclusion Criteria:

• Current active smokers

• Patients who have been hospitalized or had emergency treatment for an asthma attack in the 12 months prior to study start

• History of bleeding disorders

• History of drug allergy

• Pregnant women or nursing mothers

• Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).

• Sexually active males who have not been sterilized and are not using a condom

• History of immunocompromise, including a positive HIV

• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

• History of drug or alcohol abuse within 12 months of study start

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Xolair
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
• Placebo
Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.

Locations

Country	Name	City	State
Germany	Novartis Investigator Site	Berlin
Germany	Novartis Investigator Site	Frankfurt
Germany	Novartis Investigator Site	Munich
Netherlands	Novartis Investigator Site	Groningen
South Africa	Novartis Investigator Site	Bloemfontein
South Africa	Novartis Investigator Site	Durban

Sponsors (3)

Lead Sponsor	Collaborator
Novartis	Genentech, Inc., Tanox

Countries where clinical trial is conducted

Germany,  Netherlands,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients	The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100* [ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate.	Week 8, Week 16	No
Secondary	Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients	Late-phase allergic response (LAR) was only determined for those patients who had an LAR >= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the "best post saline (Control) FEV1" was used. LAR (%) = 100*[FEV1 (0) - Minimum FEV1 (3-8h)]/FEV1 (0).	Week 0, Week 8 and Week 16	No