Clinical Trials Logo
  1. Home
  2. Chronic Obstructive Pulmonary Disease
  3. NCT03673670

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

COPD Clinical Trial

Official title:
A Phase II, Randomized, Double Blind, Placebo Controlled, Three-way Crossover Study to Assess the Bronchodilator Effect of RPL554 Administered in Addition to Open Label Tiotropium/Olodaterol in Patients With COPD

Clinical Trial Summary

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

Clinical Trial Description

RPL554 is a dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) which are known to have a role in modulating the inflammatory airway response in respiratory diseases, including COPD. PDE3 inhibitors act as bronchodilators whilst PDE4 inhibitors have anti-inflammatory properties and there is also evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive or synergistic anti-inflammatory and bronchodilator. The two doses of RPL554 (1.5 mg and 6 mg)have been selected based on the results from prior studies investigating single and multiple ascending doses in healthy subjects, single doses in asthmatics, single/multiple ascending doses in COPD patients, and 3 days of dosing in COPD patients. These doses were demonstrated to be both effective as a bronchodilator and well tolerated.

The purpose of the study is to investigate if RPL554 has an additive bronchodilator effect when administered in combination with a commonly used anticholinergic/β-agonist combination medication, tiotropium/olodaterol (Respimat), in this patient population measured by the peak forced expiratory volume in one second (FEV1), and forced vital capacity (FVC). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03673670
Study type Interventional
Source Verona Pharma plc
Contact
Status Completed
Phase Phase 2
Start date July 16, 2018
Completion date November 13, 2018
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06000696 - Healthy at Home Pilot
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04105075 - COPD in Obese Patients
Recruiting NCT05825261 - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting NCT04075331 - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial Phase 2/Phase 3
Terminated NCT03640260 - Respiratory Regulation With Biofeedback in COPD N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn NCT04210050 - Sleep Ventilation for Patients With Advanced Hypercapnic COPD N/A
Terminated NCT03284203 - Feasibility of At-Home Handheld Spirometry N/A
Recruiting NCT06110403 - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness Phase 1/Phase 2
Active, not recruiting NCT06040424 - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Completed NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A
Completed NCT04119856 - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD N/A
Completed NCT04485741 - Strados System at Center of Excellence
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT04860375 - Multidisciplinary Management of Severe COPD N/A