A Randomized, 20 Week, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Combination With Depigoid, Versus Depigoid Only, in Adult and Adolescent Patients With Seasonal Allergic Asthma and Comorbid Seasonal Allergic Rhinoconjunctivitis - Open-label Depigoid Monotherapy Extension Periods 2007 and 2008-
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Daily Symptom Load
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Females of childbearing potential: pregnancy, birth control,breast-feeding
- •Concurrent diseases/conditions and history of other diseases/conditions
- •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).
- •patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
- •Ingredient hypersensitivity
- •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).
- •patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.
研究组 & 干预措施
Depigold+Omalizumab
Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50)
干预措施: Depigoid (Drug)
Depigold+Omalizumab
Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50)
干预措施: Omalizumab (Drug)
Depigoid+Placebo
Depigoid® (grass/rye pollen 50/50) + Placebo
干预措施: Depigoid (Drug)
Depigoid+Placebo
Depigoid® (grass/rye pollen 50/50) + Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Daily Symptom Load
时间窗: Recorded daily during the 2007 and 2008 pollen season
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.
次要结局
- Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator(52 Weeks (2007) and 104 Weeks (2008) after completion of core study)
- Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient(52 Weeks (2007) and 104 Weeks (2008) after completion of core study)
- Asthma Control Questionnaire (ACQ)(52 Weeks (2007) and 104 Weeks (2008) after completion of core study)
- Asthma Quality of Life Questionnaire (AQLQ)(52 Weeks (2007) and 104 Weeks (2008) after completion of core study)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(52 Weeks (2007) and 104 Weeks (2008) after completion of core study)
- Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline(Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study)
- Work Productivity and Activity Impairment(52 Weeks (2007) and 104 Weeks (2008) after completion of core study)
- Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)(Assist during 2007 and 2008 pollen season)
- Lung Function as Assessed by Peak Expiratory Flow (PEF)(Assist during 2007 and 2008 pollen season)
- Asthma/Rhinoconjunctivitis Symptom Severity Score(Recorded daily during the 2007 and 2008 pollen season)
- Asthma/Rhinoconjunctivitis Rescue Medication Score(Recorded daily during the 2007 and 2008 pollen season)