A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Study, Investigating the Efficacy of CRD007 in Adult Subjects with Asthma - RSPR-007

RSPR Pharma AB0 个研究点目标入组 24 人开始时间: 2015年2月4日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•1) Written informed consent must be obtained before any trial related procedures are performed
•2) Age =18 and <50 years
•3) Diagnosis of asthma according to the GINA Guidelines
•4) Fractional exhaled nitric oxide (FENO) >20 ppb (calculated average of 2 independent FENO measurements) at Visit 1
•5) Baseline FEV1 >80% of the predicted normal value at Visit 1
•6) Demonstration of PD15 at =315 mg mannitol <4 weeks prior to Visit 2
•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 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Lower respiratory tract infection <6 weeks prior to Visit 1 (subjects may be re-screened 6 weeks after resolution of respiratory infection)
•- Current smokers and ex-smokers
•- Treatment with any of the medications listed below <3 weeks prior to Visit 1:
•Inhaled steroids in a dose equivalent to >2 x 400 µg budesonide /day (dose must not be changed <4 weeks prior to Visit 1 and during the trial)
•Oral corticosteroids
•Any systemic immunomodulatory therapy
•Any systemic anti-rheumatic therapy
•Anti-IL-4 therapy
•- Clinically significant comorbidities that may be compromised by induced bronchospasm or repeated spirometry as judged by Investigator
•- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, cardiac, haematological, gastrointestinal, endocrine, inflammatory, autoimmune, pulmonary, neurological, cerebral or psychiatric disease evaluated by the Investigator to interfere with effect of the trial drug

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