We have recently commenced a new study led at Nottingham University Hospitals NHS Trust by Gr Gauri Saini, to assess the efficacy and safety of a medication called Orvepitant in patients with Idiopathic Pulmonary Fibrosis (IPF).
A Double-blind, Randomised, Placebo controlled, Two period Cross-over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis.
Why are we doing this study?
We are testing an investigational medicine called orvepitant as a treatment for chronic cough associated with idiopathic pulmonary fibrosis (IPF), a condition that causes scarring of the lungs. An investigational medicine does not yet have a license to be marketed or sold. It is still being tested to see if it works and to make sure that it is safe.
The chronic cough associated with IPF is often a dry and unpredictable cough, although a cough with sputum/phlegm can also occur, especially when waking from sleep. One possible explanation for cough in people with IPF is that the cough pathway has become too sensitive. This oversensitivity may be caused by changes in the lungs (caused by the fibrosis) that affect the nerve cells that control coughing. One of the chemicals in the body that controls the cough reflex is called Substance P and blocking the effects of this chemical may make the cough pathway less sensitive.
There are no treatments approved for treating chronic cough, but some options are available.
Orvepitant is being developed by NeRRe as a treatment for different types of chronic cough. It stops the signals produced by Substance P and so may reduce chronic cough. It is hoped that orvepitant may provide long-lasting control of chronic cough and a better quality-of-life.
Orvepitant has been given to more than 900 people so far including around 250 patients with unexplained chronic cough. We are doing this study to see if orvepitant reduces cough in people with IPF. We also want to make sure that orvepitant is safe.
This study will take place in around 30 locations worldwide. It will include about 88 participants to start with but may include up to 108 participants in total.