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

Novartis Pharmaceuticals128 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

128

Conditions

Allergic Asthma

Interventions

DepigoidDRUG

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

OmalizumabDRUG

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

PlaceboDRUG

Placebo given during the 2006 core study

Eligibility

Sex: ALLMin age: 12 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigator site

Nuremberg, Germany

Outcomes

Primary Outcomes

Daily Symptom Load

The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.

Time frame: Recorded daily during the 2007 and 2008 pollen season

Secondary Outcomes

Asthma/Rhinoconjunctivitis Symptom Severity Score

The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome.

Time frame: Recorded daily during the 2007 and 2008 pollen season

Asthma/Rhinoconjunctivitis Rescue Medication Score

Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient's entries in their diaries.

Time frame: Recorded daily during the 2007 and 2008 pollen season

Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator

Data from ClinicalTrials.gov

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