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)
This study is looking into a new tablet called NAL ER, designed to help people with Idiopathic Pulmonary Fibrosis (IPF) who suffer from persistent coughing. IPF is a serious lung condition that can cause a dry, hacking cough. Researchers are comparing NAL ER to a 'dummy' pill (placebo) to see if it reduces how often people cough over 6 weeks. They are also testing different doses of NAL ER to find the safest and most effective amount. The study will carefully check for any side effects and how the treatment affects participants' overall well-being and quality of life. This is an early-stage study (Phase II) to gather more information about this potential new treatment.
At a glance
What is this study about?
This research study is focused on people who have Idiopathic Pulmonary Fibrosis, or IPF. IPF is a long-term lung disease that can cause a lot of coughing, which can be very disruptive and uncomfortable. The main goal of this study is to explore if a new medicine, called NAL ER (which stands for Nalbuphine Extended-Release), can help to relieve this cough. It's an important step in finding better ways to manage the symptoms of IPF.
To do this, the study is comparing different doses of NAL ER with a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This helps the researchers understand if any improvements are truly due to the medicine or something else. Neither the participants nor the doctors will know who is getting the real medicine or the placebo – this is called 'double-blind' and helps keep the results fair and accurate.
The study will look closely at how a person's cough changes over 6 weeks. Researchers will count how often people cough, both during the day and at night, and also check how they feel overall. They'll also monitor for any side effects to make sure the medicine is safe. These findings will help doctors decide if NAL ER could be a helpful treatment for IPF-related cough in the future.
Key takeaways
- This study is testing a new tablet for IPF cough.
- It compares NAL ER with a dummy pill (placebo).
- It aims to find safe and effective doses.
- Participation involves regular clinic visits over 6 weeks.
- You will be closely monitored for cough changes and side effects.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. Both men and women are welcome to take part.
While the exact details aren't fully listed here, typically, studies like this look for people who have been diagnosed with Idiopathic Pulmonary Fibrosis and are experiencing a cough. There are usually other specific health requirements or conditions that might mean someone can't join, for example, if they have certain other medical problems or are taking particular medications.
It's important to remember that these are just general guidelines. Your doctor or the study team will be able to tell you if you meet all the necessary criteria to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you at least 18 years old?
- Do you have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
- Are you currently experiencing a cough related to your IPF?
- Are you willing to attend regular clinic appointments for 6 weeks?
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to make sure you meet all the health requirements. If you qualify, you would be randomly assigned to one of four groups: three groups would receive different doses of the NAL ER tablet, and one group would receive a placebo (dummy pill).
You would take the study medication regularly as instructed. Over the course of 6 weeks, you would attend several appointments at the study clinic. During these visits, the research team would assess your cough frequency, often using special monitors to count coughs. They would also monitor your general health, check your vital signs (like blood pressure and heart rate), take blood and urine samples, and ask you to complete questionnaires about your cough and how you are feeling overall. You will also have heart tracings (ECGs) and lung function tests (spirometry).
After your last dose of the study medicine, you would have a follow-up period of 14 days where your health would continue to be monitored, especially for any withdrawal symptoms. The total duration of your active participation in the study would be approximately 6 weeks, plus the follow-up period.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease that causes scarring in your lungs, making it harder to breathe and often leading to a persistent cough.
What does 'double-blind' mean in a study?
It means neither you nor the doctors will know if you are getting the active medicine or a dummy pill (placebo). This helps make the study fair.
What is a 'placebo'?
A placebo is a pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is truly effective.
How long will I be in the study?
You would be actively involved in the study for about 6 weeks, with an additional 14-day follow-up period after your last dose of medication.
Is NAL ER already approved for use?
No, NAL ER is an experimental drug being tested in this study. It is not currently available as a regular treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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