Action of Tezepelumab on airway inflammation in moderate-severe asthma
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults with Inadequately Controlled Asthma on Inhaled Corticosteroids and at least one additional asthma controller (CASCADE)
IRAS ID
252819
Contact name
Christopher Brightling
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-002069-21
Duration of Study in the UK
1 years, 11 months, 25 days
Research summary
This study will find out if an experimental medication called tezepelumab will work and be safe for the treatment of severe asthma. This study will help us better understand how the body reacts to tezepelumab during inflammation of airways in the lungs and whether the medication helps to improve the effects of asthma.
The study will include approximately 110 patients with asthma. In order to participate, patients must have inadequately controlled, moderate-to-severe asthma, and must be 18-75 years old. Patients must also have background asthma therapy of a medium or high dose inhaled corticosteroid (ICS) plus at least one additional medication to control asthma, both taken throughout the whole study period.
Eligible patients will be randomly allocated either tezepelumab or placebo for the whole study. The study medication will be given as an injection under the skin every 4 weeks.
Visits will consist of a screening period of up to 4 weeks, a treatment period of 28 weeks and a post-treatment follow-up period of 12 weeks. Randomized patients will undergo tests such as physical exams, vital signs, ECG, safety blood and urine. They will also be asked to complete questionnaires and undergo lung function and inflammation tests. Other tests performed at the randomization visit & the end of treatment period visit include Fractional exhaled nitric oxide (FeNo), Computed Tomography (CT) scans, Airwave Oscillometry (AO), Airway Hyperresponsiveness (AHR), Bronchoscopy/Bronchial Brushing and Bronchoalveolar Lavage (BAL).
Patients who stop the study treatment will be asked to attend clinic for all regularly scheduled visits to check their safety, and the effect of the study treatment. The Investigator will also advise the patient about alternative options for continued follow-up. A patient may also withdraw from the study at any time without prejudice to further treatment.
The study is anticipated to continue until February 2021.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0326
Date of REC Opinion
17 Dec 2018
REC opinion
Further Information Favourable Opinion