EUCTR2013-001958-10-SK进行中（未招募）1 期
A Prospective, Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Confirmatory Study Assessing Efficacy and Safety of the IMUNOR Therapy Versus Placebo in Children with Recurrent Respiratory Tract Infections
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female pediatric subjects aged 3-10 years, inclusive;
- •2.Parents or a legal guardian of the subject willing to sign and date a written informed consent for participation of their child in the study. For children aged = 7 years of age, being able to understand the provided information, an informed assent shall be also obtained;
- •3.Subjects with confirmed or suspected secondary immunodeficiency with properly documented recurrent RTIs of the upper and/or lower respiratory tract, or acute otitis media episodes,with = 5 episodes during the last October to September period, among them = 3 episodes in the period from October to March;
- •4.Parents or a legal guardian able to cooperate and come for the required site visits.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 210
- •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. Subjects with known hypersensitivity to any ingredient of the study medication;
- •2. Subjects with a congenital immunity disorder confirmed by a laboratory and/or genetic examination;
- •3. Subjects with documented anatomical respiratory tract anomalies;
- •4. Subjects with documented presence of focuses or airway obstruction (adenoids, Grade IV tonsillar hypertrophy and/or chronic tonsillitis, foreign body or nasal polyps);
- •5. Subjects with documented chronic middle ear inflammation, cholesteatoma, chronic ear drum perforation or inserted vent tube;
- •6. Subjects with known history of gastro-oesophageal reflux and/or aspiration syndromes;
- •7. Subjects who have undergone procedures like adenoidectomy, tonsillectomy, middle ear surgery or inflamed carious tooth extraction over the last 6 months or are planned to undergo such procedure during the course of the study;
- •8. Subjects using any immune modulating treatment (transfer factor, bacterial lysates, proteolytic enzymes, gamma-globulins, etc.) over the last 18 months or planned to receive such treatment during the course of the study;
- •9. Subjects in the initial stages of allergenic immunotherapy;
- •10. Subjects with planned vaccination scheduled for the 3 months study treatment period;
- •11. Subjects with anemia corrected by transfusion(s) or supplemental iron preparations over the last 6 months;
- •12. Subjects receiving a long term (>4 weeks) penicillin prophylaxis for chronic streptococcal infection e.g. chronic tonsillitis;
- •13. Participation in a clinical study within 30 days prior the screening visit;
- •14. Subjects with any clinically significant condition or illness, which, in the opinion of the Investigator, would affect safety of the subject or clinical evaluation of the study;
- •15. Subjects with a known history of tuberculosis.
研究者
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