We have recently commenced a new study funded and sponsored by Trevi Therapeutics, Inc and led at Nottingham by Dr Gauri Saini from the NIHR Nottingham BRC.
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)
Why is this study being done?
Doctors sometimes prescribe medicines that may slow down the scarring process, such as nintedanib (Ofev) or pirfenidone (Esbriet), or medications to reduce the inflammation in the lungs, such as steroids like prednisone. However, patients may not experience relief from coughing, shortness of breath, or fatigue even when using these types of medicines. This study will evaluate if nalbuphine extended release (NAL ER) tablet is safe, well tolerated, and effective in the treatment of cough in participants diagnosed with IPF. The study will also collect information about the level of the study drug in your blood at various times throughout the study.
What kind of drug is nalbuphine ER?
Nalbuphine ER falls into the general class of opiate drugs. Approximately 1000 participants have already received NAL ER tablets either as a single dose or as multiple daily doses for up to 26 weeks. Single doses of NAL ER up to 162 mg and multiple doses up to 162 mg twice daily were generally safe. However, the safety and tolerability of NAL ER tablets in humans are still not well known at this time.
NAL ER administered for 3 weeks during a prior study resulted in a rapid and marked reduction in daytime cough as determined by an ambulatory cough recording device. This reduction was corroborated with an equally rapid and marked reduction in patient-reported cough frequency and severity, as well as an improvement in patient-reported breathlessness among patients suffering from cough associated with IPF. NAL ER may have potential to be an effective therapy in this patient population.