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Study on Nalbuphine ER for Treating Cough in Patients with Idiopathic Pulmonary Fibrosis

Fast replyInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a condition known as Idiopathic Pulmonary Fibrosis (IPF), which is a lung disease that causes scarring of the lungs and leads to breathing difficulties. The study is testing a treatment called Nalbuphine Extended-Release (ER) tablets, which are designed to help manage cough symptoms associated with IPF. The trial will compare the effects of Nalbuphine ER with a placebo to understand its safety and effectiveness in reducing cough frequency.

The purpose of the study is to evaluate how well Nalbuphine ER can reduce the number of coughs a person with IPF experiences over a 24-hour period. Participants in the study will be randomly assigned to one of four groups, each receiving different doses of Nalbuphine ER or a placebo. The study will last for six weeks, during which participants will take the medication orally in the form of film-coated tablets. Throughout the study, participants will be monitored to assess changes in their cough frequency and any potential side effects.

By the end of the study, researchers aim to determine the most effective dose of Nalbuphine ER for reducing cough in people with IPF. The study will also gather information on any side effects experienced by participants to ensure the treatment is safe. This research could lead to improved management of cough symptoms in individuals living with IPF, potentially enhancing their quality of life.

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
Joining the study
Upon joining the study, the patient will be randomly assigned to one of four groups. Each group will receive a different dose of the study medication or a placebo.
The study is designed to be double-blind, meaning neither the patient nor the researchers will know which group the patient is in.
Step 2
Medication administration
The patient will take nalbuphine extended-release (ER) tablets or a placebo. The tablets are film-coated and taken orally.
The dosage and frequency will depend on the group assignment, but the treatment will last for a total of six weeks.
Step 3
Monitoring and assessments
Throughout the study, the patient will be monitored for changes in cough frequency using digital cough monitoring devices.
Assessments will occur at various intervals, specifically at weeks 2, 4, and 6, to evaluate the effect of the medication on cough frequency.
Step 4
Safety evaluations
Regular safety evaluations will be conducted, including clinical laboratory assessments, vital signs, spirometry, and physical examinations.
Electrocardiograms (ECGs) will also be performed to monitor heart activity.
Step 5
Completion of treatment
After six weeks, the patient will complete the treatment phase of the study.
A final assessment will be conducted to evaluate the overall impact of the medication on cough frequency and any other health parameters.
Step 6
Post-treatment follow-up
Following the last dose, the patient will be monitored for any withdrawal symptoms using the Subjective Opiate Withdrawal Scale (SOWS) for 14 days.
Additional follow-up assessments may be conducted to ensure the patient's well-being and to gather further data on the study's outcomes.

Who can join the trial?

8 criteria

Have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF), which is a lung condition, as determined by the study doctor following specific guidelines.
Have a Cough Severity Score of 4 or higher on a scale used to measure how severe the cough is, during the initial screening and at the start of the study.
Have had a chronic cough for at least 8 weeks before the screening.
Have an SpO2 level of 92% or higher, which measures the oxygen level in the blood, taken after sitting quietly for at least 5 minutes.
Have a FVC of 40% or more of what is predicted as normal. FVC stands for Force Vital Capacity, which is a measure of lung function.
Have a DLCO of 25% or more of what is predicted as normal. DLCO measures how well the lungs can transfer gas from the air to the blood.
Be male or female and at least 18 years old at the time of giving consent to participate.
Be willing and able to provide written consent, follow the study requirements and restrictions, and agree to the confidential use and storage of all data, including for scientific publication.

Who cannot join the trial?

7 criteria

Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a disease that causes scarring in the lungs, making it hard to breathe.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients with certain medical conditions that could interfere with the study results cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.

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Verified sites

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

Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen, Germany

Trial locations

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Investigated drugs

Nalbuphine Extended-Release Tablets (NAL ER) are being studied for their potential to treat cough in patients with Idiopathic Pulmonary Fibrosis (IPF). This medication is designed to be taken over an extended period, allowing it to work continuously in the body. The trial aims to determine how effective NAL ER is in reducing the frequency of coughing over a 24-hour period after six weeks of treatment.

Nalbuphine Hydrochloride

What is already known about the treatment

Nalbuphine Extended-Release Tablets (NAL ER) – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating cough associated with Idiopathic Pulmonary Fibrosis (IPF). The main therapeutic indication is to reduce cough frequency in patients with IPF. Nalbuphine works by acting on specific receptors in the brain to alter the perception of pain and potentially reduce cough reflex. It is classified as an opioid analgesic, although its use in this context is focused on cough suppression rather than pain relief.

Investigated diseases

Idiopathic Pulmonary Fibrosis (IPF) – Idiopathic Pulmonary Fibrosis is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for the lungs to transport oxygen into the bloodstream. The exact cause of IPF is unknown, which is why it is termed "idiopathic." Over time, individuals with IPF may experience worsening shortness of breath and a persistent dry cough. The disease typically progresses slowly, but the rate of progression can vary among individuals. As the lung tissue becomes more scarred, breathing becomes more challenging, impacting daily activities and quality of life.