Dose Ranging Study of RPL554 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Exclusion Criteria

• •A history of life-threatening COPD including Intensive Care Unit admission and requiring intubation.
• •COPD exacerbation requiring oral steroids in the previous 3 months
• •A history of one or more hospitalizations for COPD in the previous 6 months
• •Lower respiratory tract infection treated with antibiotics in the previous 3 months
• •Evidence of cor pulmonale or clinically significant pulmonary hypertension.
• •Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
• •Previous lung resection or lung reduction surgery.
• •Oral therapies for COPD (e.g. oral steroids, theophylline, and roflumilast) in the previous 3 months and throughout the study.
• •Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Visit 1) and remains stable during the trial.
• •A history of, or reason to believe a subject has, drug or alcohol abuse in the previous 3 years.
• •Received an experimental drug within 30 days or five half-lives of the first dose
• •Prior exposure to RPL554.
• •Women who are pregnant or breast-feeding.
• •Patients with a history of current uncontrolled disease that the Investigator believes are clinically significant.
• •myocardial infarction in the previous 6 month; congestive heart failure, a history of unstable or uncontrolled hypertension, or has been diagnosed with hypertension in last 3 months.
• •Use of oral beta blockers.
• •Major surgery (requiring general anesthesia) in the previous 6 weeks, lack of full recovery from surgery at screening, or planned surgery through the end of the study.
• •History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell).
• •Clinically significant abnormal values for safety laboratory tests
• •Significant non-compliance in previous investigational studies or with prescribed medications.
• •Requirement for oxygen therapy, even on an occasional basis.
• •Known hypersensitivity to RPL554 or its excipients/components.
• •Abnormal clinically significant 12 lead Holter findings,
• •Any other reason that the Investigator considers makes the subject unsuitable to participate.