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COMPLETEDPHASE2

The Effects of RPL554 on Top of Standard COPD Reliever Medications

A Phase II, Randomised, Double Blind, Placebo Controlled, Six Way Crossover Study to Assess the Bronchodilator Effect of RPL554 Administered on Top of Salbutamol and Ipratropium in Patients With COPD.

NCT02542254•Verona Pharma plc

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provide informed consent
•Males not donating sperm and using adequate contraception or females who are surgically sterile or postmenopausal
•12-lead ECG showing:Heart rate 45 to 90 bpm, QTcF≤450 msec, QRS ≤120 msec, PR interval ≤220 msec, no clinically significant abnormality
•Capable of complying with all study restrictions and procedures including ability to use the study nebuliser correctly.
•BMI 18 to 33 kg/m2 with a minimum weight of 45 kg.
•COPD diagnosis for at least 1 year and clinically stable COPD in previous 4 weeks
•Demonstrates reversibility to bronchodilator (two puffs of salbutamol followed by two puffs of ipratropium) via spirometry:
•* Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of ≤0.70
•* Post-bronchodilator FEV1 ≥40 % and ≤80% of predicted normal
•* ≥150 mL increase from pre-bronchodilator FEV1
+4 more criteria

Exclusion Criteria

•History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
•COPD exacerbation requiring oral steroids in the previous 3 months
•History of one or more hospitalisations for COPD in the previous 12 months
•Respiratory tract infection (both upper and lower) treated with antibiotics in previous 12 weeks
•Evidence of cor pulmonale or clinically significant pulmonary hypertension.
•Other respiratory disorders
•Previous lung resection or lung reduction surgery.
•Oral therapies for COPD in the previous 3 months and throughout the study.
•Drug or alcohol abuse in the past 3 years
•Received an experimental drug within 3 months or five half lives, whichever is longer.
+11 more criteria

Locations (1)

Medicines Evaluation Unit

Manchester, United Kingdom

Key Dates

Start Date

October 1, 2015

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

September 9, 2016

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Salbutamol

DRUG

Ipratropium

DRUG

RPL554

DRUG

Salbutamol matched placebo

DRUG

Ipratropium matched placebo

DRUG

RPL554 matched placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effects of RPL554 on Top of Standard COPD Reliever Medications

Inclusion Criteria

Exclusion Criteria

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Probiotics in Pulmonaty Rehabilitation for COPD

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