If in the last 12 months you’ve needed to take steroids for worsening asthma, then this clinical trial might be an option for you.
We are studying a potential targeted, steroid-free medicine to see if it can safely and effectively help people with asthma to gain better control of their symptoms.
If you choose to participate in our clinical trial, you’ll receive study-related care from a team of dedicated specialists and may have access to what could be a breakthrough treatment.
Who may participate
This trial is enrolling people who:
- Are 18 to 70 years old
- Have been diagnosed with uncontrolled, moderate-to-severe asthma
- Experienced an asthma attack in the last 12 months that required taking steroids by mouth (as pills) for a total of 3 or more days, injection, or intravenously (into a vein)
There are some additional criteria, which the study team will talk you through in person if you are interested in learning more.
Condition
Moderate-to-severe asthma
Age
18 to 70
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Get started — See if you may be eligible
A first step as you consider this study is to answer a 5-minute questionnaire about your health and medical history, either online or over the phone at 1-866-960-0234. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.
You will then be asked to provide your contact information for a study representative to contact you and discuss the next steps. If you’re interested, they will do a more detailed review of your medical history to see if you are able to participate. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
Your answers to these initial questions will only be linked to see if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you.
What to expect
If this trial is a good fit for you and you agree to take part, you will receive 1 of 3 doses of the study medicine or a placebo, given as an injection by a healthcare professional during your visit. A placebo looks just like the study medicine but doesn’t contain any active medicine.
For this clinical trial, there will be a 5 in 7 chance of you receiving the study medicine and a 2 in 7 chance of receiving placebo. Neither you nor the study doctor will know if the study medicine or placebo is being given.
You will also continue to use standard asthma medications, including emergency medications, if needed during the trial.
This trial will last for around 38 weeks, and you will have a total of about 10 visits.
Length of study treatment
12 weeks
Number of study visits
10
Long-term follow up
20 weeks
About Asthma
Asthma is a long-term respiratory condition that is caused by inflammation in the lungs and airways. This inflammation leads to symptoms such as shortness of breath, difficulty breathing, chest tightness, coughing and wheezing.
Asthma symptoms can vary over time and in intensity, and can be triggered by factors such as exercise, allergen exposure and changes in weather. Asthma can also be caused by an overactive immune system.
Patients with uncontrolled moderate-to-severe asthma do not respond well to standard inhaled treatments and there is a need for more effective therapies to better control the symptoms and causes of asthma.
About the Study Medicine
We are studying a new type of potential medicine called a Tri-Specific.
Most advanced treatment options available for asthmatics today target one or two proteins within the immune system.
Tri-Specifics can target three proteins within your immune system at the same time.
They may help to reduce the underlying inflammation that causes asthma. This could give people with asthma more control and we are conducting a clinical trial to find out more.
Frequently asked questions
Asthma is a long-term respiratory condition that is caused by inflammation in the lungs and airways. This inflammation leads to symptoms such as shortness of breath, difficulty breathing, chest tightness, coughing, and wheezing.
Asthma symptoms can vary over time and in intensity, and can be triggered by factors such as exercise, allergen exposure and changes in weather. Asthma can also be caused by an overactive immune system.
Patients with moderate-to-severe asthma do not respond well to standard inhaled treatments and there is a need for more effective therapies to better control the symptoms and causes of asthma.
If in the last 12 months you have needed to take steroids for at least 3 days for worsening asthma, then this clinical trial might be an option for you.
Most of the advanced treatment options available for asthma today target one part of the immune system. If you’ve been following developments within asthma over the years, you might have heard about dual-action medicine. This is a medicine that can target two parts of your immune system. A Tri-Specific doesn’t just target two parts of your immune system, it targets three. This could give more people more control and we are conducting this clinical trial to find out more.
For this clinical trial, there will be a 5 in 7 chance of you receiving the study medicine and a 2 in 7 chance of receiving placebo. A placebo looks just like the study medicine but doesn’t contain any active medicine.
Biologic medicines can target specific parts of your immune system. They are usually given as an injection and if you have a condition like asthma, they may help to control the inflammation in your body that triggers the inflammation associated with asthma.
Yes, the decision to take part is entirely the participant’s choice. If you decide to participate, you will be free to stop taking part at any time and for any reason. A decision to stop being in the study will not affect your regular medical care or any benefits to which you are entitled.
Participation will not affect your regular medical care in the future. If you stop taking part, you may be asked to return to the clinic for an ‘end-of-study assessment’ then continue with the follow-up period. Participants with ongoing medical issues may be followed until the issue is resolved or medically stable.
The study medicine and any study-related procedures are covered at no cost. Participants do not need health insurance to take part.
You will be reimbursed for any reasonable expenses that you may have as a result of taking part in this study. This may include parking, meals, or other travel-related expenses.
All information collected from this study will be kept private and will not personally identify you. Security measures will be used to protect your data against accidental or unlawful loss, alteration, or unauthorized disclosure or access.
A clinical trial (or study) is a type of medical research in which people volunteer to take part. Clinical trials are the best way to investigate how potential medicines and other medical treatments affect patients. All medicines that become available today for use in people are first tested in studies involving hundreds to thousands of participants.
