EUCTR2022-002012-23-DE进行中（未招募）1 期
A Multi-national Phase IIIb, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 Years old with Birch Pollen-induced Allergic Rhinoconjunctivitis with or without Asthma - YOBI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- STALLERGENES
- 入组人数
- 1,398
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able to sign and date the informed consent/assent prior to any trial-specific procedure.
- •(Parents and/or authorised legal representatives will have to give written informed consent for minors in their custody. Children and adolescents will be asked to sign an assent form, dependent on country-specific requirements and Investigator assessment.)
- •2. Covered by a health insurance system as per local regulation.
- •Demographics and Medical History
- •3. Aged =5 to =17 years old at the randomisation visit.
- •4. Documented, physician diagnosed, clinically relevant history of moderate to severe ARC induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous birch pollen season for ages 4 through 6 or at least 2 previous birch pollen seasons for ages 7 through 17 years at screening.
- •5. A Retrospective ARC Total Symptom Score based on the previous birch pollen season = 12 out of a maximum possible score of 18 as evaluated by the patient or by the parent/authorised legal representative AND a retrospective score of at least 30 on a general VAS (0-100) on the severity of symptoms as evaluated by the patient or by the parent/authorised legal representative if the patient is not able to perform the assessment.
- •Screening Tests and Evaluations
- •6. Positive Skin Prick Test (SPT) to Betula pendula at screening visit (the SPT is considered positive if it results in a wheal diameter = 3.0 mm [with positive control (histamine) = 3.0 mm and negative control < 0 mm]). The Sponsor will accept to include patients who have a documented positive SPT in their medical records if this SPT was performed during the previous 6 months preceding the screening visit at the same investigational site in which they are enrolled.
- •7. Positive specific IgE to pollen allergens of Betula pendula at screening (CAP-RAST birch pollen allergens specific IgE = 0.7 kU/L).
- •8. Patients with non-clinically relevant co-sensitization to other inhalant allergens such as e.g., grass/rye, mites or animal dander can be enrolled, but only if:
- •-the CAP-class with the referring allergen has to be at least 2 CAP-classes below the CAP-class for birch, and/or
- •-the SPT-wheal has to be 2 mm smaller than the SPT-wheal for birch, and
- •-clinical symptoms* and exposure to these allergens during the 2 IMP treatment periods are not anticipated (based on the clinical judgement and medical records) e.g., by not having regular contact the respective animal such as cat at home.
- •*Relevant clinical symptoms of respiratory allergy are 4 nasal symptoms (runny nose, blocked nose, sneezing, itchy nose), associated or not to 2 eye related items (itchy eyes, watery eyes), associated or not to asthma (mainly cough, wheezing, shortness of breath).
- •9. Negative urine pregnancy test on all female patients who have had their menarche prior to randomisation.
- •Lifestyle Considerations
- •10. Internet access at home or via a portable device so that patients or the parent/authorised legal representative can complete the eDiary daily via internet during the birch pollen seasons covered by the trial protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1398
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical history
- •1. Any clinical deterioration of asthma (i.e., asthma exacerbation) that resulted in emergency procedure/treatment or treatment with systemic corticosteroids within 3 months prior to randomisation.
- •2. For patients =7 years old:
- •Reduced lung function at randomisation defined as Forced Expiratory Volume in 1 second (FEV1) < 70% of the predicted value.
- •For patients with asthma, this is assessed on the patient’s usual asthma controller medication*. The following wash-out periods apply for as-needed asthma reliever medication: at least a 6-hour wash-out of Short-Acting Beta Agonists (SABAs), a 12-hour wash-out for ultra LABAs, 24 h wash-out for ultra-LABAs and 5 days or 5 half-lives for Inhaled Corticosteroids.
- •*In order to ensure that the asthmatic patients with a mild to moderate asthma status is controlled by treatment steps 1, 2 or 3 in accordance with the Global Initiative for Asthma (GINA 2022), the proper continuous asthma treatment i.e., controller” is maintained. Only the asthma reliever” medications must be stopped before performing spirometry. If an asthma medication is used as both ‘controller’ and ‘reliever’, such as inhaled corticosteroids (in combination with formoterol (LABA)), it must not be stopped before spirometry.
- •Note: This criterion does not need to be fulfilled if the patient is <7 years old, as s/he cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma.
- •3. Uncontrolled asthma with asthmatic therapies consistent with steps 4 or 5 as defined by Global Initiative for Asthma (GINA 2022) received within 12 months prior to entry in the trial. Eligible asthmatic patients will be those with mild and moderate asthma controlled by treatment(s) consistent with GINA 2022 treatment Steps 1, 2 or 3.
- •4. Oral inflammations such as oral lichen planus, oral ulcerations or oral mycosis.
- •5. Acute or chronic inflammatory or infectious upper airway diseases (excepted mild to moderate asthma) including recurrent acute or chronic sinusitis.
- •Note: Patients with fever, flu or an upper respiratory tract infection at Visit 1 (screening visit) must be treated appropriately. They can be randomised at Visit 2 (randomisation visit) only if the infectious episode is resolved.
- •6. History of eosinophilic oesophagitis.
- •7. A relevant history of systemic allergic reaction (e.g., anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema) that, in the opinion of the Investigator, may constitute an increased safety concern.
- •8. Any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
- •9. Any severe, uncontrolled disease that, upon investigator judgment, could increase the risk for trial patients (including but not limited to cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, haematological disorders, diseases of the immune system including autoimmune diseases and immune deficiencies of current clinical relevance, active malignancies).
- •Screening Tests and Evaluations
- •10. Any significant abnormal laboratory parameter or alteration in vital signs that could increase the risk for the patient, in the opinion of the Investigator.
- •11. Ongoing treatment with any allergy immunotherapy product including Specific Immunotherapy (SIT), or past full courses of SIT against birch pollen terminated for less than 5 years or past co
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