ABOUT THE CORAL TRIAL
Clinical trial for the treatment of chronic cough in patients with Idiopathic Pulmonary Fibrosis (IPF)
We are looking for patients who are diagnosed with idiopathic pulmonary fibrosis (IPF) and suffering from chronic cough. IPF is a rare, chronic and progressive lung disease where the lung tissue becomes scarred. Cough is one of the most common symptoms of patients with IPF.
Doctors sometimes prescribe medicines that may slow down the scarring process or medications to reduce the inflammation in the lungs. However, patients may not experience relief from coughing. The goal of this clinical trial is to confirm the results from the previous trial in a larger number of IPF participants and understand how different doses of the oral study drug work to reduce cough in patients with IPF.
GOALS OF THE TRIAL
The goals of the trial are to:
Confirm the results from the previous trial in a larger number of patients with IPF.
Understand how different doses of the study drug work to reduce cough in patients with IPF.
Who Can PARTICIPATE In The CORAL TRIAL?
Individuals experiencing chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF) are invited to participate in the CORAL trial.
Participate in goal trail
To be able to take part in this trial, a patient must meet the following conditions:
Any age above 18 years
Diagnosed with idiopathic pulmonary fibrosis (IPF)
Suffering from bothersome cough
Please note that this list of above conditions is not exhaustive. If you are eligible, all further examinations conducted as part of the trial will take place at the hospital/study centre under the supervision of a study physician. The study physician will inform you whether you are eligible to participate in this study.
How to Participate in the trial
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Step 2
A registered nurse will call you to ask you some additional questions and see if you qualify
Step 3
If you qualify after talking to the registered nurse, and are located near a site, you will be scheduled for a site visit
WHAT CAN you EXPECT DURING THE trial
Participation in the trial will take approximately 12 weeks. During this period, you will have
6 in-person study visits and 2 check-in phone calls.
Part 1: Screening (up to 4 weeks before treatment)
- Steps involved:
- 1. Understand the study, and decide whether to consent
- 2. Examinations to identify eligibility
Part 2: Baseline: Determine Study Eligibility (1 day before treatment period)
- Steps involved:
- 1. Treatment assignment (randomization) or end of study, if not eligible
- 2. Examinations for the study
Part 3: Treatment (6 weeks)
- Steps involved:
- 1. Week 1-2: Increasing dose over 2 weeks, depending on treatment assignment (you won't know the dose)
- 2. Week 3-6: Fixed dose
Part 4: Follow-up (2 weeks)
- Steps involved:
- 1. End of treatment
- 2. Two-week follow-up
About the study
In this trial, patients will receive either the oral study drug or placebo.
The treatment assignment will be randomly selected by a computer, which means the treatment you will receive will be based on chance. You will have a 75% chance of receiving the oral study drug and a 25% chance of receiving a placebo, which does not contain any active ingredient.
For those on the study drug different doses are administered, and the study doctor will not inform the patients during the trial which dose they will receive. The study drug and placebo will be administered orally as round tablets. This is a double-blind study, which means that neither you nor the study doctor will know if you are receiving the study drug or placebo.
The study drug has already been approved in another form (an injectable form) for use in other short-term indications since 1979. However, the safety and tolerability of the study drug in tablet form in humans are still not well known currently.
Why participate in the CORAL TRIAL
Participating in the IPF CORAL trial not only grants access to potential new treatments but also instills a sense of pride by contributing to the future advancements in treatment for numerous IPF patients.
As a part of the trial, you will be assured:
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