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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaet Leipzig	Leipzig	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Krankenhaus Bethanien gGmbH	Solingen	Germany
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Hospital La Milagrosa S.A.	Madrid	Spain
Giromed Institute S.L.P.	Barcelona	Spain
Abwchhl Odlqsvqjkog Ufzazhdfqxfkm Osooxcxt Rgplatp	Foggia	Italy
Sgemjsbcbti Pqawthhmz Wdjzhjfvxl Sotmuku Zvjzwzngo W Sxfzqbrjxc	Szczecin	Poland
Hggzcguadq Mimfbqz Cvmbaqi Slwdlopzr	Hague	The Netherlands
Evaejnv Uhvfhbriywdw Mfvczxy Cnwraqn Rscyitcac (mgmbmcy Mfc	Rotterdam	The Netherlands
Ulksjlcmfwfayg Ckzsfuc Kcoaimlaj	Gdansk	Poland
Sytdnzspm Mlabekr Zerejuxeqv	Groningen	The Netherlands
Hbrecolz Uckhsqxodmiae Mzhbtei Dx Vlcyqfmjyv	Santander	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.10.2023
Italy	Not recruiting	01.10.2023
Poland	Not recruiting	01.10.2023
Spain	Not recruiting	01.10.2023
The Netherlands	Not recruiting	01.10.2023

Trial locations

Investigated drugs:

Nalbuphine Hydrochloride

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.

Investigated diseases:

Idiopathic pulmonary fibrosis

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.

Trial ID:

2023-505296-72-00

Protocol code:

NAL03-202

NCT ID:

NCT05964335

Trial Phase:

Therapeutic exploratory (Phase II)

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

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