Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis

NCT ID: NCT00396409

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-08-31

Brief Summary

Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

Detailed Description

This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.

This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.

Conditions

Allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Depigold+Omalizumab

Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50)

Group Type: EXPERIMENTAL

Depigoid

Intervention Type: DRUG

Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)

Omalizumab

Intervention Type: DRUG

anti-IgE (Omalizumab) given during the 2006 core study

Depigoid+Placebo

Depigoid® (grass/rye pollen 50/50) + Placebo

Group Type: EXPERIMENTAL

Depigoid

Intervention Type: DRUG

Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)

Placebo

Intervention Type: DRUG

Placebo given during the 2006 core study

Interventions

Depigoid

Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)

Intervention Type: DRUG

Omalizumab

anti-IgE (Omalizumab) given during the 2006 core study

Intervention Type: DRUG

Placebo

Placebo given during the 2006 core study

Intervention Type: DRUG

Other Intervention Names

Xolair

Eligibility Criteria

Inclusion Criteria

• Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing)
• Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within > 2 previous seasons
• patients with a positive RAST (>CAP2) result for grass pollen (and/or rye pollen) specific IgE at screening (Visit 1 (V1) or within the previous 12 months.
• Patients with FEV1 > 80% of the predicted normal value for the patient at screening [V1](demostrable at least 6 hours after last short acting B-2 agonist use or 12 hours after last long B-2 acting agonist use).

Exclusion Criteria

• Females of childbearing potential: pregnancy, birth control,breast-feeding
• Concurrent diseases/conditions and history of other diseases/conditions

1. patients who have a positive history of significant clinical manifestations of allergy as a result of sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite).

2. patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).

• Ingredient hypersensitivity

1. patients with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication, any immunotherapy, or drugs related to Omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).

2. patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals, Basel +41 61 324 1111.

Locations

Novartis Investigator site

Nuremberg, , Germany

Countries

Germany

Other Identifiers

CIGE025ADE03

Identifier Type: -

Identifier Source: org_study_id