Shape the Future of COPD Research
Cold season is coming. Have you planned ahead?
The CARDINAL study is looking into a new way to help reduce
the negative effects a cold can have on people with COPD.*
COPD=chronic obstructive pulmonary disease.
*Rhinovirus is the medical term for the common cold.
What is the CARDINAL study?
Living with COPD means a cold is more than just a runny nose. It can also cause flare-ups, make it harder to breathe, and decrease lung function. That’s where the COPD And Rhinovirus-Decreasing INfection-related Acute Lower respiratory symptoms (CARDINAL) study comes in.
Designed with patients like you in mind, the CARDINAL study is looking at an investigational medicine called vapendavir to see:
If vapendavir can treat the common cold and prevent COPD symptoms from getting worse
If vapendavir is safe for people with COPD to take
The study team is now recruiting people who are interested in joining the CARDINAL study. Are you one of them? See if you qualify.
Is this study right for you?
The CARDINAL study is looking for adults who are interested in joining a clinical trial for a medicine that may help reduce the effect cold symptoms have on people with COPD. To qualify, you must be willing to visit your nearest study site, including when you have a cold, for lab tests and health checks.
You should also be comfortable using a mobile app to answer short at-home questionnaires and track your study progress.
Please note: Some medical conditions and medicines may prevent you from taking part in this study.
What you
can expect
If you join the CARDINAL study, you may or may not receive a direct medical benefit. Even if taking part does not help you, the results of this study may help other COPD patients in the future.
Screening (at study site)
Screening (at study site)
Before the study begins, you will have blood work, breathing tests, and a physical exam to make sure the study is a good fit for you.
Observation (at home)
up to 16 months
Observation (at home) up to 16 months
If you qualify, you will move into this phase. It takes place while you do NOT have a cold. You are encouraged to keep living your life as normal.
During this time, you will:
- Use a smartphone or tablet to access a mobile app and answer:
- A quick daily symptom question
- A short questionnaire about your symptoms for 3 days in a row at the beginning of each month, then once a week until the end of the month
- Take a nose swab and an at-home COVID/flu test if you think you are getting sick
- Visit the study site within 48 hours of your first symptom if your at-home test is negative for both COVID and the flu
- Check in with the study site by phone or telehealth appointment once a month
- Stay in touch with your Patient Navigator, who can help with:
- Device support
- Nose swab instructions
- Visit reminders
- Study tasks
- General study-related questions
We know this phase may feel like a lot of waiting. It is important to remember that even when it is quiet, your efforts are helping move future COPD care forward.
Treatment and follow-up (at study site and at home) about 6 weeks
Treatment and follow-up (at study site and at home) about 6 weeks
If you test positive for a cold and still qualify, you will move into the final phase.
During this time, you will:
- Start the study treatment right away at the study site
- Take the study drug once a day with food and record when you take it in your mobile app
- Visit the study site on Days 1, 3, 7, 14, 28, and 42
- Complete breathing tests, nose swabs, and health checks during study site visits
- Give blood for routine lab tests and to measure how much of the study drug is in your system
- Keep answering short questions in your mobile app each night
Your participation ends 42 days after your first dose of the study drug.
Do you qualify?
Answer these 7 questions to see if you qualify for the CARDINAL study:
Do you qualify?
Frequently asked questions
Discover answers to common questions about the study.
The CARDINAL study is a clinical trial for people with COPD. Its goal is to learn more about vapendavir, an investigational medicine, to see how well it works in treating the common cold and keeping COPD symptoms from getting worse. The study will also identify any possible side effects. By taking part in the study, you are helping researchers learn more about a possible treatment for the common cold in people with COPD.
No. Your current COPD care will not be replaced by the study drug. You should continue taking your prescribed medicines as directed by your doctor. If you do get a cold, taking over-the-counter medicine is allowed for cold symptoms.
"Investigational" means the medicine has not yet been approved for public use by any regulatory agencies, including the Food and Drug Administration (FDA).
Altesa BioSciences, a biotechnology company, is sponsoring this study. However, local doctors and nurses will be the ones working with you every step of the way.
An independent ethics board has reviewed the study to make sure your rights, safety, and well-being are protected.
If you get a cold, you will be given 1 of 2 possible doses of vapendavir or a placebo. A placebo is a "dummy" pill that looks like the study drug but has no medicine in it.
The option you receive is chosen randomly, similar to flipping a coin. Neither you nor the study team will know which one you get.
Vapendavir is a tablet being studied for people with COPD who have a cold. It is taken by mouth and works by blocking the virus from getting into the body's cells and multiplying.
If you test positive for a cold, you may receive the study drug or placebo. You will take 2 tablets once a day for 7 days with food.
Your first dose will be taken at the study site with food. The rest will be taken at home in the morning with food, unless the study team tells you otherwise. Your medicine will come in a blister card to help you stay on track.
The study uses 2 doses to learn which one works best and has the fewest side effects.
In earlier studies, most vapendavir side effects were mild. These included:
- Headache
- Dizziness
- Nausea or diarrhea
- Sinus symptoms
- Upper respiratory infections
- Worsening of prior asthma symptoms
Since vapendavir is an investigational medicine, there may be risks or side effects we do not know about yet. Serious allergic reactions are rare but possible. The study team will monitor your health closely throughout the study and a trained medical professional will be available if you experience any side effects.
Colds can make COPD symptoms worse. This can include more coughing, extra mucus, and increased trouble breathing. Some people may need extra inhalers, steroids, antibiotics, or medical care.
Yes! Altesa BioSciences can help arrange and pay for transportation to and from your study site visits. You will be paid for completing your daily questionnaires and attending study site visits.
You will also be assigned a Patient Navigator who can help you stay on track and answer your questions.
Participation in the CARDINAL study is completely voluntary. You can choose not to join or leave the study at any time without penalty.
The study can last from 2 months to 18 months, depending on if, and when, you get a cold.
By law, your health information will be protected. Your data will be labeled with a study number instead of your name and kept in password-protected files. Only approved study staff will be able to see it.