Nalbuphine ER for chronic cough in people with RCC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial compares Nalbuphine ER extended-release tablets to placebo in adults with refractory chronic cough to see if the drug reduces cough frequency and is safe. Participants must have had a cough for at least one year and show no clear cause after thorough testing, with a 24-hour cough monitor confirming elevated coughing. The study uses a randomized, controlled design with an active drug and placebo, and enrollment requires specific imaging and objective cough count criteria. Investigators are Trevi Therapeutics with multiple regional sites in Canada.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meets society guideline-based criteria for a diagnosis of RCC defined as:

  * Insufficient improvement in cough after treatment for any identified cough-associated conditions.
  * Unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of therapy.
* Persistent and chronic cough for at least one year prior to Screening.
* Chest computed tomography (CT) or chest radiograph of the thorax performed within the last 24 months and after the onset of chronic cough OR the procedure completed by the Investigator during the Screening period, that does not show any abnormality considered to be significantly contributing to the RCC in the opinion of the Principal Investigator.
* 24-hour objective cough frequency ≥10 coughs/hour based on VitaloJAK® cough monitor recording performed during the Screening and Placebo Run-in Periods as well as a minimum recording duration of 20 hours suitable for analysis during the placebo Run-in assessment.
* Forced expiratory volume in 1 second (FEV1) /forced vital capacity (FVC) ratio ≥ 60% as determined by spirometry adhering to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.

Exclusion Criteria:

* Clinical diagnosis of sleep apnea and/or use of continuous positive airway pressure (CPAP).
* Upper or lower respiratory tract infection or change in pulmonary status in the 4 weeks prior to the Screening visit or during the Screening or PBO Run-in periods.
* History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory disorder that might affect cough.
* History of uncontrolled asthma defined as one of the following:

  * ≥1 clinically significant exacerbation in the last 6 months, OR
  * ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids).
* Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vaper.
* Individuals who have stopped smoking or vaping within the past 6 months, or those with \>20 pack-year smoking history.
* Current active tuberculosis or nontuberculous mycobacterial infection, a history of latent untreated tuberculosis, or a history of incompletely treated tuberculosis.
* Speech therapy/physiotherapy for RCC starting within 4 weeks of Baseline or during the study. Speech therapy/physiotherapy is acceptable if the participant has started the therapy more than 4 weeks prior to the Baseline visit AND plans to continue the therapy through the Titration and Fixed-dose Treatment Period.
* Known intolerance \[gastrointestinal, central nervous system (CNS) symptoms\], hypersensitivity, or drug allergy considered to be related to an opioid drug or known hypersensitivity to nalbuphine or to NAL ER excipients.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Kelowna Respirology & Allergy Research
  Kelowna, British Columbia, Canada Recruiting
• Inspiration Research Limited
  Toronto, Ontario, Canada Recruiting
• Dynamic Drug Advancement Ltd
  Ajax, Canada Recruiting
• BLC Clinical Research
  Burlington, Canada Recruiting
• Recherche GCP Research
  Montreal, Canada Recruiting
• Medical Arts Health Research Group - North Vancouver
  North Van Couver, Canada Recruiting

Study contacts

• Study coordinator: Paula Buckley
• Email: Paula.Buckley@trevitherapeutics.com
• Phone: (203) 304-2499

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BLU-5937 for Refractory Chronic Cough: 24-Week Test in Adults (China Extension)

  This study tests whether BLU-5937 can reduce 24-hour cough frequency in adults with refractory or unexplained chronic cough.

  Recruiting at 38 sites Phase 3 GlaxoSmithKline · Leshan, Sichuan and 37 other locations · NCT07650084

• Cough Management app for refractory or unexplained chronic cough

  This trial will see if using a smartphone Cough Management program plus a smartwatch for four weeks lowers coughing and improves quality of life in adults 21–80 with refractory or unexplained chronic cough.

  Recruiting Hyfe Inc · Wilmington, Delaware · NCT07070895

• Behavioral Cough Suppression Therapy with or without an inhaled aid for refractory chronic cough

  This study tests whether adding an inhaled substance to behavioral cough suppression helps people with persistent chronic cough see if it works better than behavior therapy alone.

  Recruiting at 2 sites Phase 2 University of Montana · Aurora, Colorado and 2 other locations · NCT06960759

• Testing Duloxetine and Amitriptyline for Chronic Cough Relief

  This study is testing if two medications, Duloxetine and Amitriptyline, can help people with a stubborn chronic cough feel better.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT05110144

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.