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A Randomized Dose‑Ranging Study of Nalbuphine Hydrochloride Extended‑Release Tablets in Adults with Refractory Chronic Cough

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study examines individuals with Refractory Chronic Cough, a cough that continues despite standard treatments. The medication being tested is Nalbuphine ER, an oral tablet designed to release the drug slowly over time (extended‑release). A matching placebo tablet is also used. The purpose of the study is to evaluate the effect of the medication on the number of coughs per hour after six weeks.

Participants will be randomly assigned to receive either a low dose (54 mg), a higher dose (108 mg) of the study drug, or the placebo, and will take the tablet once daily for several weeks. The trial is double‑blind, meaning neither the participants nor the study staff know which tablet is being taken. Cough frequency will be recorded with a small device that counts coughs over a 24‑hour period at the start of the study and again at scheduled visits, including the main assessment at week six. Safety checks and routine visits will occur throughout the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
After you agree to join the study, you are assigned a random treatment group. the assignment is done by a computer so that neither you nor the study staff knows which group you are in.
The possible groups are nalbuphine er 54 mg, nalbuphine er 108 mg, or a matching placebo tablet.
Step 2
Receiving the study medication
You receive a supply of film‑coated tablets that are taken by mouth. each tablet contains either 54 mg or 108 mg of nalbuphine hydrochloride, or no active medicine (placebo).
The tablets are designed as extended‑release formulations, meaning the medicine is released slowly over time after you swallow the tablet.
Step 3
Daily dosing
You take one tablet each day, at the same time each day, for a total of six weeks.
The tablet is swallowed whole with a glass of water. you do not need to crush or chew the tablet.
If you are assigned the placebo, you follow the same schedule using the matching tablet.
Step 4
Cough monitoring
Throughout the study you wear a small cough monitor that records the number of coughs you make over a 24‑hour period.
The monitor is used at the start of the study (baseline) and again at scheduled visits, especially at week 6.
Step 5
Week 6 clinic visit
After six weeks of daily dosing, you attend a clinic visit.
The study team compares the cough count recorded by the monitor with the baseline count to see how your cough frequency has changed.
They also check for any side effects or safety concerns.
Step 6
End of treatment and final assessment
Following the week‑6 visit, the study medication is stopped.
A final assessment may be performed to record any remaining symptoms or side effects.
After this point you are no longer required to take study tablets or wear the cough monitor.

Who can join the trial?

5 criteria

Be a man or woman who is at least 18 years old when you sign the study paperwork.
Sign a written informed consent form that also allows the study team to use your health information that is normally kept private.
Have a diagnosis of Refractory Chronic Cough (RCC) that meets the expert guidelines, meaning either the cough did not get better enough after treating any known cause, or the cough remains unexplained even after doctors have done appropriate tests and treatment attempts.
Have a cough that has lasted for at least one year before the screening visit.
Have had a chest CT scan (a detailed X‑ray) or a regular chest X‑ray done within the past 24 months (and after the cough started) or be willing to have one done during screening, and the images must not show any serious problem that could explain the cough, according to the study doctor.

Who cannot join the trial?

5 criteria

Having a clinical diagnosis of sleep apnea or using a Continuous Positive Airway Pressure (CPAP) machine, which helps keep the airway open while sleeping.
Having an upper or lower respiratory tract infection (infection of the nose, throat, or lungs) or any change in lung health (pulmonary status) in the 4 weeks before screening, or during the screening or placebo run‑in periods.
Having a history of serious breathing disorders such as bronchiectasis (damage to the airways), chronic obstructive pulmonary disease (COPD) (a long‑term breathing problem), idiopathic pulmonary fibrosis (IPF) (scarring of lung tissue), or other significant respiratory conditions that could affect coughing.
Having uncontrolled asthma, defined as either:
- at least one clinically significant exacerbation (asthma flare‑up) in the past 6 months, or
- two or more clinically significant exacerbations in the past 12 months, where a significant exacerbation means needing treatment with systemic corticosteroids (strong steroids taken by mouth or injection).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Clinicmed Daniluk Nowak Sp. k.
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Bialystok, Poland
National Institute Of Tuberculosis And Lung Diseases
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Warsaw, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Verified
Poznan, Poland

Trial locations

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Investigated drugs

Nalbuphine ER is an oral extended‑release tablet that contains nalbuphine, a medication that works on the body's opioid receptors to help calm the cough reflex. In this study participants took the tablet once daily to see if it could lower the number of coughs they have over a 24‑hour period. The trial tested different strengths of the same tablet to find the dose that works best while staying safe.

Nalbuphine Hydrochloride

What is already known about the treatment

Nalbuphine ER - This medication is taken by mouth as a film‑coated extended‑release tablet, available in 54 mg and 108 mg strengths. Nalbuphine is already used in medical practice as a pain reliever, but it is not yet approved for treating cough, so its use for chronic cough is currently being studied in clinical trials. It works by activating the body’s kappa opioid receptors while blocking mu opioid receptors, which helps calm the cough reflex. Pharmacologically, it belongs to the opioid mixed agonist‑antagonist class.

Investigated diseases

Refractory chronic cough - A persistent cough that lasts for at least eight weeks and does not improve with usual treatments. It is often triggered by irritants, infections, or underlying airway sensitivity. Over time, the cough may become more frequent and intense, interfering with daily activities. The condition can lead to throat irritation, hoarseness, and sleep disturbance. It may gradually worsen if the underlying cause remains untreated.