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RPL554-010-2015 - Verona

Details

Therapeutic category
The type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Anti-Inflammatory

Trial status

Open

Phase
The different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

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 type

Medication

Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment

52 days

Intervention
The name of the treatment or therapy being researched

A single nebulised dose of RPL554 6mg, 1.5mg or placebo given on 3 separate visits

Last edited date

05 September 2017

Sponsor

Verona Pharma plc

Sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • A genetic diagnosis of CF
  • Spirometry demonstrating an 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: angina, recent or suspected myocardial infarction, congestive heart failure, a history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in last 3 months
  • Other non-CF related respiratory disorders: Patients with a current diagnosis of active tuberculosis, lung cancer, sarcoidosis, sleep apnoea, known alpha-1 antitrypsin deficiency or other active pulmonary diseases

CF centres running this trial

Recruiting

Papworth Hospital NHS Foundation Trust

Address

Papworth Hall Papworth Everard Cambridge Cambridgeshire CB23 3RE

Recruitment starts

February 2017

Recruitment ends

March 2018

Contact

Floto, Andres

Get in touch