EVALUATION OF THE EFFICACY AND SAFETY OF 6 REPEATED DAILY DOSES OF NEBULISED RPL554 0.018 mg/kg (6X) IN ALLERGIC ASTHMATICS

Phase 2

Completed

• Conditions: bronchial asthma; 10038716

• Registration Number: NL-OMON35912
• Lead Sponsor: Verona Pharma plc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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 <=8 mg/mL at screening.
Documented allergy by a standardized Skin Prick Test (SPT).
Reversibility in lung function for salbutamol.
Healthy.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The lungfunction will be measured by means of spirometry in which the FEV1 will<br /><br>be assessed during 6 hours on day 1, 3 and 6</p><br>

Secondary 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 Blood chemistry safety<br /><br>by standard clinical assessment Full hematological assessment (i.e., cell<br /><br>counts and coagulation status)<br /><br>Symptoms and all adverse events Subjective tolerability (i.e., taste,<br /><br>aftertaste, and smell as well as nasal irritation)<br /><br>Pharmacokinetic measures, e.g. Cmax<br /><br>Adverse Events<br /><br>Drug and metabolite concentrations in urine samples<br /><br>To explore the possibility of measuring RPL554 concentrations in exhaled breath<br /><br>condensate.<br /><br>Subjective measure: To explore the effect on quality of life of RPL554</p><br>