Frequently Asked Questions

What are research studies?

Research studies, also called clinical trials, are designed to:

  • Find new ways to prevent, diagnose, or treat illnesses
  • Understand how a potential drug or medical device may help to treat certain conditions
  • Learn how a study medicine or medical device works and whether it is safe

Why are research studies necessary?

Research studies are necessary to learn whether a study treatment or procedure works and is safe.  Without research studies, study treatments and procedures would not be available to patients who may need them.

Why do people volunteer for a research study?

People take part in a research study for many reasons.  When you participate in a research study, you help doctors and researchers learn more about a potential study treatment, procedure, or disease.  The information they learn may also help improve health care for people in the future.

Can I still see my doctor when I participate in a research study?

Yes.  You can continue to see your doctor while enrolled in a research study.  Your doctor will continue to monitor your overall health while you are in the study.

What if I do not want to enroll in a research study?

Your participation in a research study is voluntary.  You do not have to take part in a research study, and you can leave at any time, for any reason.  Talk to your doctor about your treatment options before taking part in a research study.

What happens after a research study ends?

Once a research study ends, the researchers will review the information they have collected.  At that point, they will decide whether the study treatment or procedure is safe to use and if it works.  If it is proven safe and effective in a research study, the study treatment or procedure may become a therapy option or even a standard of care after review by the local health authorities (e.g., the FDA in the US).

 

Results from a research study may be viewed at www.clinicaltrials.gov.

Who sponsors a research study?

A research study can be sponsored or funded by a variety of organizations or individuals, including healthcare providers, medical institutions, foundations, voluntary groups, and pharmaceutical companies.  It may also be sponsored by government health agencies.

 

The REBUILD Study is sponsored by Bellerophon Therapeutics.

www.bellerophon.com

How do I know if I am eligible to enroll in REBUILD?

You may qualify to take part in this study if you are:

  • Diagnosed with pulmonary fibrosis, including:
    • Idiopathic pulmonary fibrosis (IPF)
    • Other interstitial lung diseases (ILDs) or pneumonias
    • Chronic hypersensitivity pneumonitis
    • Occupational lung disease
  • 18 to 80 years of age
  • On oxygen therapy (continuously or only when exercising)

 

Additional eligibility requirements are detailed at:  https://clinicaltrials.gov/ct2/show/NCT03267108.  You should speak with your doctor about your treatment options before taking part in any research study.

If patients are already using pirfenidone or nintedanib, are they allowed to continue using these medications to treat their pulmonary fibrosis?

Yes, and patients must already be on a stable dose of medication for at least 3 months.

How many patients are expected to participate in REBUILD?

Approximately 300 patients

What is the purpose of using a placebo?

In some research studies, instead of receiving the study drug, you may instead receive an inactive drug called a placebo.  A placebo looks just like the investigational drug/therapy, and is taken in the same way, but it does not contain active ingredients.

 

Having a placebo group (a group of patients who take the inactive drug) helps to determine whether the study treatment works to improve a disease or condition.

 

Regardless of whether you receive the study treatment or placebo, your health will be closely monitored by a team of healthcare providers.  In addition, the information learned from this study may help patients in the future who have a similar condition.

Should I talk to my doctor about research studies/clinical trials?

You should discuss your treatment options with your doctor before deciding to take part in a research study.  It is important that all your doctors know that you are taking part in a research study so they can be sure it does not conflict with your other medicines or treatments.

 

www.bellerophon.com