A Study of RPL554 in Patients With Cystic Fibrosis

Details

Therapeutic category
Anti-Inflammatory
Trial status
Completed Participating Centres
Phase
Phase II

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.

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.
Trial Reference Number
89452
Trial type
Medication
Length of participation
52 days
Intervention
Anti-inflammatory
Last edited date
19/10/2018
CF sponsor
Verona Pharma plc
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • 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
Top exclusion criteria
  • Previous lung resection or lung transplant
  • Documented cardiovascular disease

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