NL-OMON42237已完成4 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 - Azithromycin in PCD
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
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
- 年龄范围
- 2 至 99（—）
入选标准
- •A confirmed diagnosis of PCD: Characteristic clinical symptoms and high speed video microscopic recordings of abnormal ciliary beat pattern and/or frequency;
- •and either abnormally low nasal NO production, and/or abnormal ciliary ultra-structure demonstrated by transmission electron microscopy analysis or high resolution immunofluorescence (not incl. isolated IDA) and/or an unequivocal genetic mutation recognized to cause PCD.
- •Age * 7 years and * 50 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 systemic, inhaled maintenance antibiotics
- •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.
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.
- •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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尚未招募
不适用
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