Randomised, Double-Blind, Placebo-Controlled Evaluation of the Safety and Duration of Action of 2 Single Inhaled Doses, 0.036 mg/kg (12X) and 0.072 mg/kg (24X), of RPL554, a Dual PDE 3/4 Inhibitor, in Allergic Asthmatics
- Conditions
- bronchial asthma10038716
- Registration Number
- NL-OMON34422
- Lead Sponsor
- Verona Pharma plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Males or females of non-child bearing potential.
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).
Healthy.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Respiratory safety (i.e., effects on the upper and lower airways):<br /><br>Gastrointestinal safety/tolerability (i.e., nausea, vomiting, and abdominal<br /><br>pain or diarrhea).<br /><br>Cardiovascular safety (i.e., clinically relevant effects on heart rate &<br /><br>rhythm, and conduction times; and sitting blood pressure<br /><br>Blood chemistry safety by standard clinical assessment<br /><br>Full hematological assessment (i.e., cell counts and coagulation status)<br /><br>Symptoms and all adverse events<br /><br>Subjective tolerability (i.e., taste, aftertaste, and smell as well as nasal<br /><br>irritation)</p><br>
- Secondary Outcome Measures
Name Time Method <p>An increase in post-drug FEV1 (expressed as percent change from baseline FEV1<br /><br>at t=0) over time.<br /><br>Pharmacokinetic measures, e.g. Cmax<br /><br>Adverse Events<br /><br>Drug and metabolite concentrations in urine samples</p><br>