EUCTR2011-001698-22-NL进行中（未招募）不适用
EVALUATION OF THE EFFICACY AND SAFETY OF 6 REPEATED DAILY DOSES OF NEBULISED RPL554 0.018 mg/kg (6X) IN ALLERGIC ASTHMATICS - Daily Dose RPL554
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Male
入选标准
- •Healthy males between 18 and 55 years of age at screening (both inclusive)
- •Clinically stable mild to moderate asthma, defined as
- •o Documented history of mild to moderate persistent asthma, first diagnosed by an MD at least 6 months prior to the screening visit and currently controlled by beta-agonists on an as needed” basis only
- •o Clinically stable asthma, i.e. stable asthma symptoms and baseline prebronchodilator FEV1 values within 10% (i.e. study day 1 compared to screening) (preferably measured at the same time of day ±3 h); stable use of as needed” Short-Acting Beta2 Agonist (SABA) but not on controller medication (see exclusion criteria)
- •o Pre-bronchodilator FEV1 =70% of predicted
- •o Documented bronchial hyper-responsiveness to inhaled Methacholine (MCh) with a PC20Meth of =8 mg/mL at screening
- •o No recent respiratory tract infections (within 3 weeks of screening and during study)
- •o Documented reversibility in lung function defined as = 12% or = 200 mL increase in FEV1 compared to pre-salbutamol 200 microgram value.
- •No clinically relevant history of cardiovascular (including arrhythmias) disease; no active hyperthyroidism
- •No clinically relevant history of chronic or malignant diseases (except for in situ basalioma)
- •Body mass index (BMI) between 18 and 33 kg/m2 (both inclusive)
- •Systolic blood pressure (SBP) 100-155 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 beats per min (inclusive), measured on the arm with the highest blood pressure after resting for 5 min in the supine position
- •No clinically significant findings on physical examination other than allergy and mild to moderate persistent asthma
- •12-lead ECG without clinically relevant abnormalities
- •Non-smokers or ex-smokers (stopped for at least 6 months before screening, and <10 pack-years)
- •No history of anaphylaxis, or of severe food or medication allergy
- •Haematology, clinical chemistry and urinalysis test results not deviating from the normal range to a clinically relevant extent as deemed by the investigator
- •Negative results from urine drug and cotinine screens (for nicotine use)
- •Negative screening for Hepatitis B, Hepatitis C and HIV
- •Documented allergy by a standardized Skin Prick Test (SPT): i.e. a positive wheal response to one or more of the common airborne allergens: Grass or tree Pollen, House Dust Mite, D. Farinae, cat, dog, or horse-dander, Aspergillus Fumigatus, A. Alternata, Artemisia Vulgaris (in the past 1 year)
- •Steroid-naïve, or not on inhaled/nasal corticosteroids for at least one month and 8 weeks of systemic therapy before the study
- •No use of anti-IgE (omalizumab) in the past 6 months
- •No systemic or aerosol use of the following: leukotriene receptor antagonists (LTRA), theophylline, long acting beta agonists (LABA), or antihistamine such as H1 receptor antagonist for 2 weeks before the study
- •No nasal medications (steroids, antihistamines, cromones) for one month (for nasal steroids), or 2 weeks for other medications; xylomethazoline (1 week); nasal NaCl 0.9% allowed
- •Ability to communicate well with the investigator and to understand and comply with the requirements of the study
- •Signed informed consent
- •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 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Numbe
排除标准
- •Desensitization therapy in the past 5 years
- •Severe exacerbation requiring hospital evaluation and/or admission in the past 2 years
- •Unstable/uncontrolled disease within 3 weeks of participation in the study
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
- •Treatment with another investigational drug within 3 months prior to screening
- •Known hypersensitivity to any excipients of the drug formulations
- •History or clinical evidence of alcoholism within the 3-year period prior to screening (i.e. regular use of more than 21 units of alcohol/week for males and more than 14 units/week for females)
- •Excessive caffeine consumption, defined as > 8 cups/per day at screening – unable to discontinue caffeine consumption for at least 8 h before and during the testing
- •History or any other clinical condition, judged to be a contraindication for participation in the study as judged by the PI
- •Loss of 250 mL or more of blood within 3 months prior to screening
- •Any abnormalities on lab or urine results outside the normal range, deemed clinically significant by the investigator (and with written consent of the sponsor)
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