Comparison of RPL554 With Placebo and Salbutamol in Asthmatic Patients

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The number of people with of asthma and allergy is still increasing and a large number of patients still do not have their asthma well controlled. There is therefore a need for new asthma treatments that work well and have less side effects. The study compares a new experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Verona Pharma plc
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Provided written informed consent

• Males agree not to donate sperm and either be abstinent or use adequate contraception. Females to be post-menopausal or surgically sterile

• Non-smoker or ex-smoker >6 months

• Diagnosed asthma for at least 6 months

• Pre-bronchodilator FEV1 ≥60% and ≤90% of predicted normal value and ≥1.5 L at screening

• Increase in FEV1 of 15% within 30 minutes after a 2.5mg dose of nebulised salbutamol

• Systolic blood pressure 90 to 145 mmHg, diastolic blood pressure 50 to 90 mmHg and heart rate 45 to 80 beats per minute (bpm) after resting for 5 minutes in a supine position (average from two measurements)

• Capable of withdrawing from LABAs, LAMAs and SAMAs before screening and during study and SABAs before screening and for 8 hours before each dose

Exclusion Criteria:

• Asthma exacerbation in the last 3 months

• Any prior life threatening episode of asthma (intensive care admission)

• Any clinically significant disease or disorder or clinically relevant screening result

• QTcF interval >450 ms or QT interval >500 ms or other abnormality in ECG

• History of ischemic heart disease or heart failure. History of recurrent or current clinically significant arrhythmia or ECG abnormality as judged by the investigator

• Treatment with systemic glucocorticosteroids within 30 days before screening

• A suspected/manifested infection according to WHO risk classification 2, 3 or 4