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.
A seven way crossover study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled RPL554 compared to salbutamol and placebo in patients with mild to moderate chronic asthma. Salbutamol is a marketed beta-2 agonist typically used to treat bronchospasm (due to any cause, allergen asthma or exercise-induced), as well as chronic obstructive pulmonary disease but has associated dose-related systemic side effects. RPL554 is a dual PDE3 and PDE4 inhibitor that has bronchodilatory and anti-inflammatory actions and also the potential to stimulate increases in mucociliary clearance via its proven ability to activate CFTR. Four different doses of RPL554 will be compared with placebo and a two doses of salbutamol as benchmarks for bronchodilation and systemic side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
29
A dual PDE3 and PDE4 inhibitor
a beta-2 receptor agonist
RPL554 placebo containing no active ingredients
Skane University Hospital
Lund, Sweden
Celerion
Belfast, United Kingdom
Spirometry
FEV1
Time frame: 12 hours
Spirometry
FEV1
Time frame: 4, 6 and 8 hours
Systemic pharmacodynamic effect on blood pressure
Supine blood pressure in the 4 hours after nebulisation
Time frame: 4 hours
Systemic pharmacodynamic effect on pulse rate
Supine Pulse rate in the 4 hours after nebulisation
Time frame: 4 hours
Systemic pharmacodynamic effect on ECG heart rate
ECG heart rate in the 4 hours after nebulisation
Time frame: 4 hours
Vital signs (Supine pulse rate)
Supine pulse rate
Time frame: 12 hours
Vital signs (Supine blood pressure)
Supine systolic and diastolic blood pressure
Time frame: 12 hours
ECG
12-lead ECG parameters
Time frame: 12 hours
Pharmacokinetics (AUC)
RPL554 AUC
Time frame: 12 hours
Pharmacokinetics (Cmax)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
RPL554 Cmax
Time frame: 12 hours
Pharmacokinetics (tmax)
RPL554 tmax
Time frame: 12 hours
Pharmacokinetics (half life)
RPL554 half life
Time frame: 12 hours
Pharmacokinetics (MRT)
RPL554 MRT
Time frame: 12 hours