EUCTR2018-000244-26-GB进行中（未招募）1 期
A double-blind, placebo-controlled study to assess the effects of inhaled PC945 in the treatment of culture-positive Aspergillus or Candida fungal bronchitis in subjects with moderate to severe asthma or other chronic respiratory diseases.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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. Subject must be male or female, aged 18 years (inclusive) or older (at the time of consent).
- •2. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and is willing to participate.
- •3. Subjects with a diagnosis of moderate to severe asthma (GINA Step 3, 4 or 5) made by a respiratory physician and treated with an inhaled steroid or other chronic respiratory disease.
- •a. For subjects with asthma this must have a diagnosis shown either by:
- •i. Historical evidence of:
- •1. Increased airway hyper-responsiveness (methacholine PC20 <8 mg/ml).
- •2. Airflow obstruction (FEV1/FVC ratio of less than 70%) and short-term variations in FEV1 (>12%).
- •ii. Bronchodilator reversibility =12% or =200 mL improvement in FEV1 post bronchodilator after administration of a short-acting
- •beta agonist at screening.
- •b. Subjects with other chronic respiratory disease (such as COPD or bronchiectasis) susceptible to fungal bronchitis.
- •4. Subject must have a positive sputum fungal culture with one or more colonies of A. fumigatus complex/A. niger complex or 200 or more colonies of yeast measured using a modified standard approach on one occasion obtained within the 28-day screening period.
- •5. Subject must be able to produce a spontaneous sputum sample.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Subjects who have received more than 2 weeks of intravenous (IV), oral or inhaled antifungal therapy within 2 months of Visit 3.
- •2. Subjects taking medication that could significantly increase the risks of AEs with triazoles.
- •3. Subjects who are receiving antiretroviral protease inhibitors.
- •4. At screening, has a clinically significant bacterial chest infection that has not been adequately treated.
- •5. Subjects who have used an experimental medical device or received an experimental drug within 3 months or within a period less than five times the experimental drug’s half-life, whichever is longer, before the first dose of the study drug is scheduled.
- •6. Clinically significant screening abnormalities (including, but not limited to, vital signs, ECG, laboratory tests, physical examination and spirometry) that, in the Investigator’s opinion, exclude the subject from participation in the study.
- •7. Positive test at screening for hepatitis B virus infection, or antibodies to hepatitis C virus.
- •8. If female, the subject is pregnant (e.g. has a positive serum ß human chorionic gonadotropin at screening or a positive urinary pregnancy test pre-dose on Day 1), lactating or breast feeding.
- •9. Subject is an employee or a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
- •10. Any other reason that the Investigator considers makes the subject unsuitable to participate.
研究者
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