This study evaluates the addition of RPL554 to standard reliever medications for chronic obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in a randomised sequence: 1. salbutamol, 2. ipratropium, 3. salbutamol + RPL554, 4. ipratropium + RPL554, 5. RPL554 6. Placebo
The purpose of this study is to investigate if RPL554 has an additive bronchodilator effect when administered in combination with standard of care bronchodilators in patients with COPD.This study investigates the pharmacodynamic effect of RPL554 using spirometry and whole body plethysmography compared to placebo, when administered in addition to a beta2 agonist (salbutamol), a muscarinic antagonist (ipratropium) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
200 micrograms salbutamol administered using a pressurised metered dose inhaler (pMDI)
40 micrograms ipratropium administered using a pMDI
6 mg RPL554 administered using a nebuliser
Medicines Evaluation Unit
Manchester, United Kingdom
8 hour spirometry
Forced expired volume in one second (FEV1) over 8 hours post-dose
Time frame: 8 hours
12 hour spirometry
FEV1 over 4, 6 and 12 hours post-dose
Time frame: 12 hours
Whole body plethysmography
Functional residual capacity, residual volume, total lung capacity, specific airway conductance, specific airway resistance at 1 and 4 hours post-dose
Time frame: 4 hours
Area under the curve (AUC)
AUC for RPL554 plasma concentration
Time frame: 12 hours
Maximum plasma concentration (Cmax)
Cmax for RPL554 plasma concentration
Time frame: 12 hours
Time to maximum plasma concentration (Tmax)
Tmax for RPL554 plasma concentration
Time frame: 12 hours
Adverse events
Continuous measurement of adverse events throughout the study
Time frame: Up to 94 days
Safety laboratory tests
Laboratory safety tests at screening, before each treatment and end of study
Time frame: Up to 94 days
ECG
12 lead ECG at screening, before and up to 12 hours after each treatment and end of study
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Placebo pMDI
Placebo pMDI
Nebulised placebo
Time frame: Up to 94 days
Vital signs
Blood pressure and pulse rate at screening, before and up to 12 hours after each treatment and end of study
Time frame: Up to 94 days