A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
This study has been completed.
Sponsor:
Novartis
Collaborators:
Genentech
Tanox
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00624832
First received: February 18, 2008
Last updated: April 12, 2011
Last verified: April 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Xolair Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients [ Time Frame: Week 8, Week 16 ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients [ Time Frame: Week 0, Week 8 and Week 16 ] [ Designated as safety issue: No ]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).
| Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Drug: Xolair
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
Other Name: Xolair
|
|
Experimental: Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Drug: Xolair
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
Other Name: Xolair
|
|
Experimental: Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Drug: Xolair
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
Other Name: Xolair
|
|
Placebo Comparator: Placebo
By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
|
Drug: Placebo
Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624832
Locations
| Germany | |
| Novartis Investigator Site | |
| Berlin, Germany | |
| Novartis Investigator Site | |
| Frankfurt, Germany | |
| Novartis Investigator Site | |
| Munich, Germany | |
| Netherlands | |
| Novartis Investigator Site | |
| Groningen, Netherlands | |
| South Africa | |
| Novartis Investigator Site | |
| Bloemfontein, South Africa | |
| Novartis Investigator Site | |
| Durban, South Africa | |
Sponsors and Collaborators
Novartis
Genentech
Tanox
Investigators
| Principal Investigator: | Novartis | Novartis investigator site |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00624832 History of Changes |
| Other Study ID Numbers: | CIGE025A2210 |
| Study First Received: | February 18, 2008 |
| Results First Received: | January 21, 2011 |
| Last Updated: | April 12, 2011 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Novartis:
|
Asthma allergen challenge bronchoprovocation Methacholine challenge |
serum Immunoglobulin E Nitric Oxide skin prick test |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Immunoglobulin E |
Immunoglobulins Antibodies Omalizumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Anti-Allergic Agents Therapeutic Uses Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013