RecruitingRare disease

Study on the Effects of Morphine Sulfate for Relieving Breathlessness and Cough in Patients with Fibrotic Interstitial Lung Disease

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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 the effects of a medication called morphine sulfate on patients with a lung condition known as Fibrotic Interstitial Lung Disease. This condition involves scarring of the lung tissue, which can lead to symptoms like breathlessness and coughing. The study will use a form of morphine that is released slowly into the body, known as a prolonged-release tablet. The medications being tested include Malfin, Contalgin, and MST CONTINUS, all of which contain morphine sulfate. A placebo will also be used for comparison.

The purpose of the study is to examine how a 4-week treatment with slow-release morphine affects the feeling of breathlessness in patients with fibrotic interstitial lung diseases. Participants will take the medication orally, and the study will compare the effects of morphine to those of a placebo. The study will last for a total of 4 weeks, during which participants will be monitored for changes in their symptoms.

Throughout the study, participants will be asked to report on their symptoms, such as breathlessness and cough, and may undergo tests like a 6-minute walk test to measure their walking distance and oxygen levels. The goal is to see if morphine can help improve the quality of life for people with this lung condition by reducing symptoms like breathlessness and cough.

The research process

The trial runs in 5 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 informed about the trial's purpose, which is to assess the effect of slow-release morphine on breathlessness in patients with fibrotic interstitial lung disease.
The patient will provide informed written consent to participate in the study.
Step 2
Initial assessment
The patient will undergo an initial assessment to establish baseline measurements. This includes evaluating the average VAS (Visual Analogue Scale) score for breathlessness over the last 24 hours.
Additional assessments may include a 6-minute walk test to measure walking distance and level of oxygen desaturation, as well as completing questionnaires related to cough and lung disease.
Step 3
Medication administration
The patient will receive either slow-release morphine or a placebo in the form of prolonged-release tablets. The specific product names include Malfin, Contalgin, and MST Continus.
The medication will be administered orally, and the treatment will last for 4 weeks.
Step 4
Ongoing monitoring
Throughout the 4-week treatment period, the patient will be monitored for any changes in symptoms and side effects.
Regular check-ins may be scheduled to ensure the patient's well-being and to track the effectiveness of the treatment.
Step 5
Final assessment
At the end of the 4-week treatment period, the patient will undergo a final assessment to measure any changes in the VAS score for breathlessness.
The 6-minute walk test and questionnaires will be repeated to evaluate any improvements in walking distance, oxygen levels, and overall lung health.

Who can join the trial?

7 criteria

The patient must have **fibrotic interstitial lung disease**. This is a condition where the lungs become scarred and stiff, making it hard to breathe.
The patient should have a **GAP score** of 2-3. This score helps doctors understand the severity of the lung disease based on gender, age, and lung function.
There must be signs of **fibrosis** on an **HRCT scan**. This scan is a detailed type of X-ray that shows lung damage like scarring, changes in the airways, or reduced lung size.
The patient should have an **MRC dyspnea score** of 3 or higher. This score measures how much breathlessness affects daily activities.
The patient must provide **informed written consent**, meaning they agree to participate after understanding the study details.
The patient must be **18 years or older**.
The patient must be able to make decisions independently, meaning they are **authoritative**.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with **Fibrotic Interstitial Lung Disease** cannot participate. This is a condition where the lungs become scarred and stiff, making it hard to breathe.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Both male and female patients can participate, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population are not excluded, meaning the study is open to a wide range of participants.

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Verified sites

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Verified
Gentofte Hospital
Hellerup, Denmark
Verified
Odense University Hospital
Odense, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Morphine is being studied for its potential to relieve symptoms of breathlessness and cough in patients with fibrotic interstitial lung disease. In this trial, a slow-release form of morphine is used to see if it can help improve the quality of life for these patients by reducing their discomfort over a period of four weeks.

What is already known about the treatment

Morphine – Morphine is administered orally in a slow-release form, designed to provide prolonged relief from symptoms. It is currently being studied in clinical trials for its potential to alleviate breathlessness and cough in patients with fibrotic interstitial lung disease. The main therapeutic indication is to manage symptoms of dyspnea and cough associated with this condition. At the molecular level, morphine works by binding to opioid receptors in the brain, which helps to reduce the perception of breathlessness and discomfort. It is classified as an opioid analgesic, commonly used for pain relief but now being explored for its benefits in respiratory conditions.

Investigated diseases

Fibrotic Interstitial Lung Disease – This is a group of lung disorders characterized by progressive scarring of lung tissue, which leads to a gradual decline in lung function. The scarring, or fibrosis, makes the lung tissue stiff, which can make it difficult for the lungs to work properly. Over time, this can result in symptoms such as persistent dry cough and shortness of breath, especially during physical activity. The disease can vary in severity and progression, with some individuals experiencing a slow progression while others may have a more rapid decline. The exact cause of the fibrosis is often unknown, but it can be associated with environmental exposures, certain medications, or underlying autoimmune diseases. The condition is considered rare and can significantly impact the quality of life due to breathing difficulties.