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

Verona Pharma plc0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Non-smokers .
•Documented history of mild to moderate persistent asthma, currently controlled by beta-agonists on an *as needed* basis only.
•Clinically stable asthma / baseline prebronchodilator FEV1 values within 10% (i.e. study day 1 compared to screening).
•Pre-bronchodilator FEV1 >=70% of predicted.
•Bronchial hyperresponsiveness to inhaled Methacholine (MBr or MCh) with a PC20Meth of <=8 mg/mL at screening.
•Documented allergy by a standardized Skin Prick Test (SPT).
•Reversibility in lung function for salbutamol.

•Desensitization therapy in the past 5 years.
•Severe exacerbation requiring hospital evaluation.
•Unstable/uncontrolled disease within 3 weeks of participation in the study.
•History or clinical evidence of any disease.
•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.
•Excessive caffeine consumption.
•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.

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