EUCTR2022-002012-23-SE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
- 699
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
- •The patient must fulfil the following inclusion criteria to be eligible for the trial:
- •1. Able to sign and date the informed consent/assent form prior to any trial-specific procedure. Patients may check a box on the assent form if they are unable to provide a signature.
- •(Parents and/or authorised legal representative(s) will have to give written informed consent for minors in their custody.)
- •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 (TSS), based on the
- •previous birch pollen season = 12 out of a maximum possible score of 18 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, at screening. Retrospective ARC TSS (TSSO-18) is rated the same way as Daily Symptom Score (DSS) (DSSO-18).
- •6-9: 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 Immunoglobulin E (IgE) to pollen allergens of
- •Betula pendula at screening (CAP-RAST birch pollen allergens specific IgE = 0.7 kU/L).
- •8. Negative urine pregnancy test on all female patients of childbearing potential or who have had their first menarche prior to randomisation.
- •Lifestyle Considerations
- •9. Internet access at home or via a portable device so that patients or the parent/authorised legal representative can complete the e-Diary in a dedicated application on a mobile phone daily via internet. Patients will start scoring at randomisation, i.e., 4 months before the pollen season.
- •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
- •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 asneeded
- •asthma reliever medication at least a 6-hour wash-out of Short-
- •Acting Beta Agonists (SABAs), a 12 hour wash-out of Long-Acting Beta
- •Agonists (LABAs) 24h wash-out for ultra-LABAs and 5 days or 5 halflives
- •for inhaled corticosteroids.
- •*In order to ensure that the asthmatic patients with a mild to moderate
- •asthma status are 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 performing
- •spirometry.
- •3. Severe or uncontrolled asthma or asthma treated with asthmatic
- •therapies consistent with steps 4 or 5 as defined by 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 GINA 2022 treatment with Steps 1, 2 or 3.
- •4. Severe 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
- •6. History of eosinophilic oesophagitis or with current severe or persistent gastroesophageal symptoms including dysphagia or chest pain that, in the opinion of the investigator, may constitute an increased safety concern.
- •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 [upon the Investigator's judgment based on the benefit/risk assessment] and immune deficiencies of current clinical relevance, active malignancies).
- •Screening Tests and Evaluations
- •10. A documented clinically relevant history of seasonal ARC symptoms
- •caused by an allergen source, other than tree pollen from the birch
- •homologous group, with a season overlapping the BPS.
- •11. A documented clinically relevant history of perennial ARC symptoms
- •caused by an allergen source such as animal dander to which the patient
- •is exposed during the BPS.
- •12. Any significant abnormal laboratory parameter or alteration in vital
- •signs that could increase the risk for the patient, in the opinion of t
研究者
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