Reduction of daily asthma medication with tezepelumab in patients 12 to 80 years with severe asthma
Research type
Research Study
Full title
A Multicentre, Randomised, Open-Label, Parallel-Group, Phase IIIb Study to Assess the Potential for Tezepelumab-treated Patients with Severe Asthma to Reduce Background Therapy While Sustaining Asthma Control and Clinical Remission (ARRIVAL)
IRAS ID
1010234
Contact name
Sarah Liddle
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat severe asthma. Asthma is a disease that causes the air passages to become inflamed and narrow. People who have asthma may wheeze, cough, and have shortness of breath. People with severe asthma usually have to take 1 or more daily asthma medications to control their asthma.
The trial drug tezepelumab is designed to help decrease inflammation in the airways. Tezepelumab is approved for treating severe asthma and only needs to be given once a month. In this trial, researchers want to learn more about how tezepelumab works to help reduce the need for daily asthma medications while still keeping severe asthma under control. Reducing the need for daily asthma medications may help to decrease the costs for people taking these medications and the potential for side effects from these medications.
In this trial, researchers will do tests and look at the participants’ asthma medication use and asthma symptoms to rate how controlled their asthma is.
This is a randomized, open-label trial. Randomized means that a computer program will randomly assign the treatment each participant receives. The randomized part of this trial will start at Week 24. Open-label means the participants, researchers, trial doctors, and other trial staff will know what each participant is receiving. The participants will receive treatment for up to 68 weeks but will be in the trial for up to 76 weeks total. Then they will be put into groups depending on how controlled their asthma is.
This trial will include about 300 participants. All participants will be 12 to 80 years of age. They will have severe asthma that requires daily treatment with certain asthma medications.
3 hospitals in the UK are taking part in the study. Participants will visit the study site up to 20 times.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0140
Date of REC Opinion
22 Jul 2024
REC opinion
Further Information Favourable Opinion