Bronchodilator Effect of RPL554 Administered in Addition to Tiotropium/Olodaterol in Patients With COPD

Completed · Phase 2 · Has a placebo group

Conditions studied: COPD

In brief

The study investigates the effect of 3 days of twice daily treatment of two different doses of RPL554 (a phosphodiesterase \[PDE\]3/4 inhibitor) or placebo, each administered in addition to once daily tiotropium/olodaterol (Respimat) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will receive each of the three treatment combinations in a randomized sequence using a crossover design

Key facts

Study ID

NCT03673670

Run by

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

People needed

79

Starts

2018-07-16

Expected to finish

2018-11-13

Last updated by the study team

2019-10-10

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Male or female aged 40 and 80 years
• For males, not to donate sperm and either be sexually abstinent or use contraception as specified by the protocol. For females, be of non-childbearing potential or use a highly effective form of contraception
• 12-lead ECG with heart rate between 45 and 90 beats per minute, QTcF ≤450 msec for males, and ≤ 470 msec for females, QRS interval ≤120 msec and no clinically significant abnormality including morphology
• Screening Holter report with a minimum of 18 hours recording that is able to be evaluated for rhythm analysis showing no abnormality which indicates a significant impairment of patient safety or which may significantly impair interpretation
• Capable of complying with all study restrictions and procedures including ability to use the study nebulizer and Respimat® correctly.
• Body mass index (BMI) between 18 and 36 kg/m2 and minimum weight of 45 kg.
• COPD diagnosis for at least 1 year and clinically stable COPD for 4 week
• Post-bronchodilator (two puffs of salbutamol/albuterol followed by two puffs of ipratropium) spirometry at Screening:
• Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of ≤0.70
• Post-bronchodilator FEV1 ≥30 % and ≤70% of predicted normal
• Demonstrates ≥150 mL increase from pre-bronchodilator FEV1
• A chest X-ray showing no abnormalities, which are both clinically significant and unrelated to COPD.
• Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
• Current and former smokers with smoking history of ≥10 pack years. 14. Capable of withdrawing from long acting bronchodilators for the duration of the study, and short acting bronchodilators for 8 hours prior to dosing.

You may not qualify if…

• A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
• COPD exacerbation requiring oral or parenteral steroids, or lower respiratory tract infection requiring antibiotics, in the last 3 months
• A history of one or more hospitalizations for COPD in the last 12 months
• Intolerance or hypersensitivity to tiotropium, olodaterol, atropine, ipratropium, or RPL554.
• Evidence of cor pulmonale or clinically significant pulmonary hypertension.
• Other respiratory disorders
• Previous lung resection or lung reduction surgery.
• Use of oral COPD medications, except mucolytics, in the last 3 months
• Pulmonary rehabilitation, unless such treatment has been stable in the last 4 weeks
• History of, or reason to believe a patient has, drug or alcohol abuse within the past 5 years.
• Inability to perform acceptable spirometry or whole body plethysmography
• Received an experimental drug within 30 days or five half lives, whichever is longer.
• Patients with uncontrolled disease that the Investigator believes are clinically significant. This includes any hepatic disease, or an alanine aminotransferase or aspartate aminotransferase>2 x upper limit of normal (ULN).
• Documented cardiovascular disease: arrhythmias, angina, recent (<1 year) or suspected myocardial infarction, congestive heart failure, unstable or uncontrolled hypertension, or diagnosis of hypertension in the last 3 months
• Use of non-selective oral β-blockers.
• Major surgery (requiring general anesthesia) in the last 6 weeks or will not have fully recovered from surgery, or planned surgery through the end of the study.
• A disclosed history or one known to the Investigator, of significant non compliance in previous investigational studies or with prescribed medications.
• Required use of oxygen therapy, even on an occasional basis.
• Symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma.
• 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 (hematology, biochemistry, virology or urinalysis) as determined by the Investigator
• Any other reason that the Investigator considers makes the patient unsuitable to participate.

Where it is running

• Clinical Site Partners, LLC — Winter Park, Florida, United States
• Allied Biomedical Research Holdings, d/b/a Vitalink Research — Greenville, South Carolina, United States
• Respiratory Clinical Trials LTD, — London, United Kingdom
• Medicines Evaluation Unit — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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