Comparison of RPL554 With Placebo and Salbutamol in Asthmatic Patients

NCT02427165 | Completed Phase 2

• 1 other identifier: RPL554-008-2014
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 2

Brief Summary

The number of people with of asthma and allergy is still increasing and a large number of patients still do not have their asthma well controlled. There is therefore a need for new asthma treatments that work well and have less side effects. The study compares a new experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Spirometry

  FEV1

  12 hours

Secondary Outcomes (12)

• Spirometry

  4, 6 and 8 hours

• Systemic pharmacodynamic effect on blood pressure

  4 hours

• Systemic pharmacodynamic effect on pulse rate

  4 hours

• Systemic pharmacodynamic effect on ECG heart rate

  4 hours

• Vital signs (Supine pulse rate)

  12 hours

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Single dose of nebulised placebo solution

Drug: Placebo

RPL554 Dose 1

EXPERIMENTAL

0.4 mg single dose nebulised RPL554

Drug: RPL554

RPL554 Dose 2

EXPERIMENTAL

1.5 mg single dose nebulised RPL554

Drug: RPL554

RPL554 Dose 3

EXPERIMENTAL

6 mg single dose nebulised RPL554

Drug: RPL554

RPL554 Dose 4

EXPERIMENTAL

24 mg single dose nebulised RPL554

Drug: RPL554

Salbutamol Dose 1

ACTIVE COMPARATOR

2.5 mg single dose nebulised salbutamol

Drug: Salbutamol

Salbutamol Dose 2

ACTIVE COMPARATOR

7.5 mg single dose nebulised salbutamol

Drug: Salbutamol

Interventions

RPL554 DRUG

A dual PDE3 and PDE4 inhibitor

Also known as: VMX554, VRP554

RPL554 Dose 1; RPL554 Dose 2; RPL554 Dose 3; RPL554 Dose 4

Salbutamol DRUG

a beta-2 receptor agonist

Salbutamol Dose 1; Salbutamol Dose 2

Placebo DRUG

RPL554 placebo containing no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written informed consent
• Males agree not to donate sperm and either be abstinent or use adequate contraception. Females to be post-menopausal or surgically sterile
• Non-smoker or ex-smoker \>6 months
• Diagnosed asthma for at least 6 months
• Pre-bronchodilator FEV1 ≥60% and ≤90% of predicted normal value and ≥1.5 L at screening
• Increase in FEV1 of 15% within 30 minutes after a 2.5mg dose of nebulised salbutamol
• Systolic blood pressure 90 to 145 mmHg, diastolic blood pressure 50 to 90 mmHg and heart rate 45 to 80 beats per minute (bpm) after resting for 5 minutes in a supine position (average from two measurements)
• Capable of withdrawing from LABAs, LAMAs and SAMAs before screening and during study and SABAs before screening and for 8 hours before each dose

You may not qualify if:

• Asthma exacerbation in the last 3 months
• Any prior life threatening episode of asthma (intensive care admission)
• Any clinically significant disease or disorder or clinically relevant screening result
• QTcF interval \>450 ms or QT interval \>500 ms or other abnormality in ECG
• History of ischemic heart disease or heart failure. History of recurrent or current clinically significant arrhythmia or ECG abnormality as judged by the investigator
• Treatment with systemic glucocorticosteroids within 30 days before screening
• A suspected/manifested infection according to WHO risk classification 2, 3 or 4

Sponsors & Collaborators

• Verona Pharma plc: lead

Study Sites (2)

Skane University Hospital

Lund, Sweden

Location

Celerion

Belfast, United Kingdom

Location

Related Publications (1)

• Bjermer L, Abbott-Banner K, Newman K. Efficacy and safety of a first-in-class inhaled PDE3/4 inhibitor (ensifentrine) vs salbutamol in asthma. Pulm Pharmacol Ther. 2019 Oct;58:101814. doi: 10.1016/j.pupt.2019.101814. Epub 2019 Jun 14.

  PMID: 31202957 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

ensifentrine; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Lief Bjermer

  Skane University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

• Johnston Stewart

  Celerion, Northern Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 27, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

SE (1); GB (1)