Your asthma may be under control, but is your inhaler still controlling you?
Your asthma may be under control, but is your inhaler
still controlling you?
Learn about the ARRIVAL study of a once-a-month treatment for people with severe asthma.
Study Overview
What is the purpose of the ARRIVAL study?
This study is being done to see if people with severe asthma who take the study drug, tezepelumab, can reduce maintenance therapy without loss of asthma control.
What is the study drug?
The study drug is tezepelumab, which is available under the brand name TEZSPIRE®. It is a prescription medicine used as an add-on maintenance treatment for people aged 12 and older with severe asthma.Who can be in the study?
To be considered for the study, participants must meet the following basic criteria:
- 18 to 80 years of age (12 to 80 years of age in Canada)
- Diagnosed with severe asthma within the past 10 years
- Require daily treatment with a high-dose inhaled corticosteroid and a long-acting beta-agonist (such as Advair, Symbicort, Seretide, Dulera, or other free or fixed combination inhalers)
- Have had at least one asthma attack in the past year that required treatment with a systemic steroid (such as an oral steroid, intramuscular or IV steroids) or requiring hospitalization.
Taking Part in the Study
What is involved in the ARRIVAL study?
Approximately 360 patients will be screened to enroll approximately 300 patients at sites around the world. The study lasts up to 72 weeks (16-17 months) and is divided into 4 parts:
1
SCREENING
(up to 4 weeks)
Before you begin study treatment, you will undergo a series of tests to find out if you can join the study. This is called screening. If you don’t meet the screening criteria, the reasons will be explained. Your study doctor or treating physician will talk to you about other treatment options.
You will be provided with an electronic diary (eDiary) to begin keeping track of certain asthma symptoms, medications, and to answer study questionnaires. You will use the eDiary every day during the study.
2
STUDY TREATMENT
PART 1
(24 weeks)
If you qualify at the end of the screening period, you will begin receiving subcutaneous injections of tezepelumab in addition to taking your current asthma medications. You will visit the research site every 4 weeks for the injections and other study tests and procedures. Twelve weeks into this period, your regular asthma medications may be changed to a different inhaled corticosteroid and rescue inhaler.
3
STUDY TREATMENT
PART 2
(32 weeks)
During this period, you will be assigned to one of 3 groups:
- Group 1 participants will continue to take tezepelumab but will receive lower doses of the study-assigned inhaled corticosteroid. The dose of inhaled corticosteroid you receive may change depending on your asthma symptoms.
- Groups 2 and 3 will continue to take tezepelumab and the same dose of inhaled corticosteroid as in Part 1.
MAINTENANCE
(16 weeks)
- Group 1 participants will continue to take tezepelumab and the lowest daily dose of the study-assigned inhaled corticosteroid reached during Study Treatment Part 2.
- Groups 2 and 3 will continue to take tezepelumab and the same dose of inhaled corticosteroid that they have been on.
Should I participate in the study?
There is no certainty that you will have any benefit from taking part in the study. The information collected during this study may help doctors better treat patients with severe asthma in the future.
Taking part in a clinical study is completely voluntary. Participation is not required, and if enrolled, you can choose to end your participation at any time and for any reason.
Will the study cost me anything?
Participating in this study will not cost you anything. Study drugs, study visits, and study-related tests and examinations are at no charge. You may also be reimbursed for reasonable study-related expenses such as travel or parking.
About Clinical Studies
What is a clinical research study?
A research study is designed to help us learn more about medical devices, drugs, or diagnostic tests. Health authorities use the results of research studies to decide if a study treatment should be made available for use in a particular country.
How are my rights protected?
Every research study is reviewed by an Institutional Review Board (IRB) or Ethics Committee (EC), which helps ensure that the study is conducted safely and that the rights and privacy of study participants are protected. Research studies are conducted by experienced and trained medical professionals who monitor the health of participants throughout the study.