EUCTR2013-004664-58-NL进行中（未招募）1 期
RANDOMIZED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFICACY AND SAFETY OF AZITHROMYCIN (AZN) MAINTENANCE THERAPY FOR 6 MONTHS IN SUBJECTS WITH PCD - A DOUBLE-BLIND, PARALLEL GROUP STUDY
Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark0 个研究点目标入组 125 人开始时间: 2014年11月19日最近更新:
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
- 入组人数
- 125
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
- •A confirmed diagnosis of PCD:
- •- Characteristic clinical symptoms;
- •- High speed video microscopic recordings of abnormal ciliary beat pattern and/or frequency;
- •- Abnormally low nasal NO production < 77 nl/min;
- •- Abnormal ciliary ultra-structure demonstrated by transmission electron microscopy analysis or high resolution immunofluorescence (not incl. isolated IDA);
- •- An unequivocal genetic mutation recognized to cause PCD.
- •Age = 7 years and < 40 years at inclusion;
- •Ability to swallow tablets;
- •At least 30 days treatment with antibiotics prescribed against respiratory tract infections/pulmonary exacerbations in the previous 2 years;
- •No AZN treatment within 1 month prior to screening (visit 1);
- •No current therapy with maintenance antibiotics, except from inhalation antibiotics or oral ciprofloxacin against Pseudomonas aeruginosa;• FEV1 % predicted > 40 % at screening (Visit 1);
- •Ability to perform spirometry and Multiple Breath Washout (MBW);
- •Personally provide, or have a legal guardian provide written informed consent to participate in the trial, according to local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 65
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known infection with Nontuberculous Mycobacteria (NTM) (found in sputum in the past 6 months prior to screening (Visit 1), Achromobacter xylosoxidans, Burkholderia cepacia or chronic infection with Pseudomonas aeruginosa;
- •Be currently participating in, or have participated in another investigative drug trial within four weeks prior of screening (Visit 1);
- •A history of allergic reaction to macrolide antibiotics incl. ketolide antibiotics, peanut, or to any of the excipients of ‘Azithromycine CF 250 mg’ or to any of the ingredients of the placebo (Carboxymethylstarch sodium, Cellulose microcryst. (PH 102), Colloidal anhydrous silica, Gelatin, Glycerol distearate, Lactose monohydrate, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Potato starch, Pregelatinised maize starch, Sodium laurilsulfate, Sodium starch glycolate, Soya lecithin, Talc, Titanium dioxide (E171) and Xanthan gum);
- •Liver disease with Alanine transaminase (ALT) twice or more the upper limits of normal or history of portal hypertension ;
- •Known kidney disease with serum creatinine > 150 µmol/l and/or Glomerular Filtration Rate (GFR) < 50 ml/min;
- •Known congenital or documented acquired prolonged QT-interval, cardiac arrhythmia, clinical relevant bradycardia, severe heart failure, or electrolyte disturbances.
- •Known myasthenia gravis.
- •Current treatment with ciclosporin, coumarin-like oral anticoagulants (e.g. warfarin), digoxin, ergotamine derivatives (e.g. methylergometrine), nelfinavir, rifabutin and active substances known to prolong QT interval such as amiodarone and other class ?A and class ??? antiarrhythmics, cisapride, terfenadin, antipsychotic agents such as pimozide, antidepressants such as citalopram and fluoroquinolones such as moxifloxacin and levofloxacin;
- •Be pregnant or breastfeeding; plan to become pregnant whilst in the trial; or be female of childbearing potential (at the discretion of the investigator) using an unreliable form of contraception;
- •Requirement of home oxygen (not incl. supplemental oxygen for use only when exercising, mountaineering or travelling by air) or assisted ventilation;
- •Have any concomitant medical, psychiatric, or social condition that, in the Investigator’s opinion, would put the subject at significant risk, may confound the results or may significantly interfere with the subject’s participation in the trial.
研究者
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