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Study on Dronabinol for Reducing Severe Breathlessness in Patients with Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Verified siteRegistered drugNo 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 the effects of a medication called Dronabinol on patients with severe and very severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The study aims to find out if Dronabinol, which contains a compound from synthetic cannabis, can help relieve breathlessness in these patients. Dronabinol is taken as a hard capsule by mouth.

Participants in the study will receive either Dronabinol or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to compare the effects of Dronabinol with the placebo to see if there is a difference in how patients feel and function in their daily lives. The trial will last for a period of four weeks, during which participants will switch between taking Dronabinol and the placebo without knowing which one they are taking at any given time.

The main goal of the study is to assess whether Dronabinol can reduce the discomfort of daily breathlessness and improve daily activities for people with COPD. The study will also look at other aspects of health, such as anxiety, depression, sleepiness, and physical activity, to understand the overall impact of the treatment. Participants will be monitored through various tests and questionnaires to gather information on their symptoms and overall well-being.

The research process

The trial runs in 8 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, eligibility is confirmed based on specific criteria such as age, language proficiency, and health condition.
Written consent is required to participate in the trial.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the severity of breathlessness and overall health status.
This includes tests like the Numeric Rating Scale (NRS) for breathlessness and other health questionnaires.
Step 3
Medication phase 1
Participants receive either placebo or dronabinol in the form of hard capsules taken orally.
The dosage and frequency are determined by the study protocol, and participants are monitored for any changes in symptoms.
Step 4
Evaluation phase 1
During this phase, the effects of the medication are evaluated using various tests and questionnaires.
These include assessments of breathlessness, daily activities, and overall health impact.
Step 5
Crossover phase
Participants switch from the initial medication to the alternative (from placebo to dronabinol or vice versa).
This phase ensures that each participant receives both treatments at different times.
Step 6
Medication phase 2
Participants take the second medication as per the study protocol, continuing with the same monitoring and assessments.
Step 7
Evaluation phase 2
The effects of the second medication are evaluated similarly to the first phase.
Comparisons are made between the two phases to assess the impact of dronabinol versus placebo.
Step 8
Final assessment
A comprehensive evaluation is conducted to gather final data on the participant's health and response to the treatments.
This includes a review of all collected data and any final health assessments.

Who can join the trial?

10 criteria

Have **chronic obstructive pulmonary disease (COPD)**, which is a lung condition that makes it hard to breathe.
Experience **refractory dyspnea**, meaning difficulty breathing that doesn't improve with usual treatments.
Have a **GOLD 3 or 4** classification of COPD, indicating severe or very severe stages of the disease.
Experience **breathlessness** with a score of 3 or higher on the **mMRC scale**, which measures how breathlessness affects daily activities.
Be **18 years or older**.
Be **mentally capable** and of legal age to give consent.
Be able to **understand and speak Danish**.
Provide **informed written consent**, meaning you agree to participate after understanding the study details.
If you are a **fertile woman** (having regular periods), you must have a **negative pregnancy test** before joining the trial.
If you are **fertile and sexually active**, you must use **safe contraception** during the study and for 4 weeks after. This includes methods like an intrauterine device (IUD) or hormonal contraception such as pills, implants, patches, rings, or injections.

Who cannot join the trial?

8 criteria

Patients who do not have chronic obstructive pulmonary disease (COPD) cannot participate. COPD is a long-term lung disease that makes it hard to breathe.
Patients who are not in the age range specified for the study cannot participate. The study is for adults only.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently using certain medications that might interfere with the study cannot participate.
Patients who have a history of substance abuse or addiction cannot participate.
Patients who have participated in another clinical trial recently cannot participate.

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Verified sites

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Verified
Sygehus Lillebaelt Vejle Sygehus
Vejle, Denmark

Trial locations

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Investigated drugs

Dronabinol is a medication being tested in this clinical trial. It contains a compound called Δ9-tetrahydrocannabinol, which is derived from synthetic cannabis. The purpose of this trial is to see if Dronabinol can help reduce severe breathlessness in patients who have severe and very severe chronic obstructive pulmonary disease (COPD).

What is already known about the treatment

Dronabinol – Dronabinol is administered orally, typically in capsule form. It is currently being studied in clinical trials for its potential to relieve severe breathlessness in patients with chronic obstructive pulmonary disease (COPD). The main therapeutic indication for Dronabinol in this context is to alleviate symptoms associated with severe and very severe COPD. At the molecular level, Dronabinol works by interacting with cannabinoid receptors in the brain, which can influence the perception of breathlessness. It is classified pharmacologically as a cannabinoid, derived from synthetic cannabis, containing the active compound delta-9-tetrahydrocannabinol (THC).

Investigated diseases

Chronic Obstructive Pulmonary Disease – Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that makes it difficult to breathe. It is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. The disease progresses slowly, with symptoms such as chronic cough, mucus production, and shortness of breath worsening over time. As the condition advances, individuals may experience increased breathlessness, especially during physical activities. COPD is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. The disease can lead to frequent respiratory infections and reduced quality of life.