A Study of RPL554 in Patients With Cystic Fibrosis

Details

Therapeutic approach
Anti-Inflammatory
Trial status
Closed with results Participating Centres
Trials Tracker ID
TT001701
Last updated
19/10/2018

Full title

A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis.

Study details

The study drug, called RPL554, is a potential new inhaled drug that is being developed for the treatment of breathing and lung diseases, including cystic fibrosis.

The study drug is a liquid that is breathed in using a device called a nebuliser, which is a commonly used device that turns a liquid into a fine mist that can then be inhaled into the lungs where it can then be taken into the body. Over 240 people have been given RPL554 in clinical studies so far. Two different formulations (how the drug is made up) have been tested in these studies; 105 people have received the original formulation of RPL554 and 144 have received either one dose or up to 11 doses (between 0.4 mg and 24 mg) of a newer formulation of RPL554. If you decide to take part in this study, you will be given two different doses (1.5 mg and 6 mg) of this newer formulation RPL554. You will also be given a placebo (a dummy drug containing the same inactive ingredients as RPL554 but no active ingredients).

The main purpose of this study is to look at the effect your body has on the study drug by measuring the amount of RPL554 in your blood (this is called “pharmacokinetics”). The study will also investigate how much RPL554 can open up the airways (bronchodilation), what effect it has on inflammation and what side effects it has.


Phase
Phase 2
Length of participation
52 days
CF sponsor
Verona Pharma plc
CF sponsor type
Commercial

Who can take part?

Age range
18 years and older
Including people

Age 18 year or older
FEV1 of ≥40% and ≤80% of predicted normal
Capable of withdrawing from long acting bronchodilators until the end of the treatment period, and short acting bronchodilators for 8 hours prior to administration of study treatment

Excluding people

Previous lung resection or lung transplant
Documented cardiovascular disease

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CF centres running this trial

Closed

Cambridge Royal Papworth Hospital (Adults)

CTAP centre
NHS Trust
Royal Papworth Hospital NHS Foundation Trust
Address
Papworth Road
CB2 0AY
Local site investigator
Andres Floto
Trial Coordinators
Deepa George
Victoria Christenssen