Asthma clinical trials can help researchers find new ways to improve the health of people with asthma. If you or your child is diagnosed with asthma, you may be interested in participating in asthma research. Here are six things you should know before enrolling in an asthma clinical trial.

1. Clinical Trials Can Help Develop New Asthma Treatments

The goal of a clinical trial is to find out if a new treatment is both safe and effective in people with a health condition. This includes those who have been underrepresented in research to date (such as women, children, and people of color). Asthma treatments must be studied in a clinical trial before they are approved by the U.S. Food and Drug Administration (FDA) for use in the general population.

• How and why some people get asthma
• How asthma progresses
• If asthma can be prevented
• What triggers asthma
• How diverse groups of people respond to different types of treatment

2. Your Safety Is Closely Monitored

Committees called Institutional Review Boards (IRBs) approve and monitor clinical trials to protect the safety, rights, and welfare of the people participating. They review each study to make sure the potential benefits of the study outweigh any potential risks to the participants. Any clinical trial must be approved by an IRB before participants can join. You can ask to see any IRB approval documents during your initial conversations about any clinical trial.

A process called informed consent gives you important information about the clinical trial, so you can decide if you want to participate. During the informed consent process, you can ask any questions and review any documents before agreeing to participate. This process continues throughout the study. If your child is participating in a study, researchers should explain the details of the study — as well as the risks and benefits — in a way they can understand.

Before joining the study, you would sign an informed consent document. This document doesn’t mean you must participate. You can stop participating in the study at any time for any reason.

3. New Treatments Are Tested by Healthy Volunteers First

If you have asthma and join a clinical trial for a new treatment or drug, researchers already know some of the potential side effects. This is because new treatments are usually tested by healthy volunteers who do not have asthma.

There are four phases of new drug development. In phase 1, the new drug or treatment is given to a small group of about 20 to 80 healthy volunteers to learn about its safety and find out what the side effects are.

In phase 2, researchers use a larger group of people — usually between 100 and 300 people — to find out if the new treatment can improve the symptoms of asthma. Phase 2 studies typically last a few months or up to two years.

In phase 3, researchers test the new treatment on an even larger group of people, usually several thousand people in different locations around the world. Phase 3 studies usually last between one and four years. When the study is complete, the researchers can send the results to the FDA, which will decide whether to approve the new treatment.

After a new treatment is FDA-approved, clinical trials continue in phase 4 studies. Phase 4 studies give researchers more information about how the new treatment works in the general population under real-world conditions.

4. Clinical Trials Don’t Always Use a Placebo

Some people may hesitate to join a clinical trial because they worry about being given an inactive treatment called a placebo. While some clinical trials have placebos, there are some situations where all trial participants get the best treatment currently available, and no placebo is used. Some participants will also receive the new treatment being tested.

Most clinical trials are randomized. This means you are randomly assigned to try a particular treatment. Neither you nor the researchers will know which treatment you had until the trial is over.

The different types of clinical trials include:

• Treatment trials — Test new drugs, new combinations of drugs, or new ways of using a drug to treat a disease
• Prevention trials — Test new ways of preventing a disease from developing or coming back using vaccines, lifestyle changes, or new medication
• Screening trials — Test new ways of detecting a disease before symptoms develop
• Diagnostic trials — Test new ways of diagnosing a disease
• Behavioral trials — Test new ways behavior can impact health
• Quality of life trials — Test new ways to improve quality of life for people with a disease

5. There Are Rules for Who Can Participate in a Clinical Trial

Before you can enroll in a clinical trial, the researchers will make sure you’re eligible to take part in the study. The research protocol will specify who should be included and excluded from the study based on certain characteristics. These criteria make sure the study is safe for everyone who participates and the researchers can get the information they need.

The inclusion and exclusion criteria for a clinical trial may consider the following:

• Your age
• Your weight and body mass index (BMI)
• Your gender
• Whether you are pregnant or might become pregnant
• The severity of your asthma
• Your asthma symptoms
• How often you use your quick-relief medications
• Your lung function
• Current and past asthma treatments you’ve tried
• Any other medical conditions you have

6. Clinical Trials Might Benefit You and the Asthma Community

Clinical trials might give you access to additional medical care and the newest potential treatments. Some clinical trials may offer financial compensation for your time and travel.

Asthma clinical trials can have the potential to improve the care of everyone with asthma by increasing knowledge about the disease and finding new safe and effective medications. When you participate in a clinical trial, you can play a part in moving medical science forward. Some racial and ethnic groups have been underrepresented in clinical trials to date. Their inclusion is greatly needed to improve care for diverse populations.

Some of the new asthma treatments in development are being tested to see if they can slow or stop the progression of the disease instead of just treating the symptoms. The asthma treatment options available today — such as inhaled corticosteroids and bronchodilators — can improve asthma control, but they are not a cure.

Is Joining a Clinical Trial Right for You?

Talk to your doctor or pediatrician about the possible risks and benefits of enrolling in a clinical trial. Your health care providers may be able to help you find a clinical trial you’re eligible for in your area. You can also find a list of all clinical trials managed by the National Institutes of Health online at ClinicalTrials.gov.

Some questions you may want to ask your doctor before joining a clinical trial include:

• What’s the purpose of the trial?
• What is the time frame for the study?
• How will my safety be monitored?
• Who is in charge of my care while I’m in the study?
• What are my responsibilities?
• How can I find out the results of the study when it’s over?
• What are the possible short- and long-term benefits?
• What are the possible short- and long-term risks?
• What other treatment options are available?
• If I receive the placebo during a trial, is there a way for me to get the new medication early?
• How will this study affect my daily life?
• Will it cost me any money to participate in this study?
• Will my insurance cover any of the costs of the study?
• How much time will I have to decide whether I want to participate?

Talk With Others Who Understand

MyAsthmaTeam is the social network for people with asthma and their loved ones. On MyAsthmaTeam, members come together to ask questions, give advice, and share their stories with others who understand life with asthma.

Have you participated in a clinical trial? Are you interested in being a part of asthma research? Share your experience in the comments below, or start a conversation by posting on your Activities page.