bronchial asthma
Conditions
Interventions
RPL554 or placebo
Sponsors
Verona Pharma plc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Males. 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The lungfunction will be measured by means of spirometry in which the FEV1 will be assessed during 6 hours on day 1, 3 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Respiratory safety (i.e., effects on the upper and lower airways): Gastrointestinal safety/tolerability (i.e., nausea, vomiting, and abdominal pain or diarrhea). Cardiovascular safety (i.e., clinically relevant effects on heart rate & rhythm, and conduction times; and sitting blood pressure Blood chemistry safety by standard clinical assessment Full hematological assessment (i.e., cell counts and coagulation status) Symptoms and all adverse events Subjective tolerability (i.e., taste, aftertaste, and smell as well as nasal irritation) Pharmacokinetic measures, e.g. Cmax Adverse Events Drug and metabolite concentrations in urine samples To explore the possibility of measuring RPL554 concentrations in exhaled breath condensate. Subjective measure: To explore the effect on quality of life of RPL554 | — |
Countries
Netherlands
Outcome results
None listed