Effect of Tralokinumab on airway inflammation in asthma
Research type
Research Study
Full title
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS)
IRAS ID
179169
Contact name
Christopher Brightling
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-000857-19
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
The purpose of this trial is to examine the effect of tralokinumab treatment on inflammation and other changes in the structure of the airway in asthma patients who are otherwise uncontrolled on current standard of care. The trial will also investigate the safety and tolerability of tralokinumab. The trial involves performing bronchoscopy and obtaining samples from patient’s airways. It also involves performing CT scan of lung, specialized lung function assessments, obtaining samples of patient’s blood, sputum, nasal secretions and nasal cells at various time points. In addition the trial will also assess levels of tralokinumab and also of certain substances found in the body and if they can be used to predict whether a patient will benefit from treatment with tralokinumab. The trial also involves specialized testing to evaluate the changes at the molecular level of the collected samples. Patients will also be provided an electronic diary and hand-held spirometer for use at home to record daily asthma symptoms, rescue medication use and to answer asthma related questions.
Patients who are currently treated with inhaled corticosteroid and aged between 18 and 75 may be eligible to take part in the study which will be over 12 visits and last for approximately 20 weeks. But for female patients of child bearing potential the trial will last for 30 weeks with 1 additional visit. Regular visits to the clinic are required for the entire duration of the study, to assess the health of the patient, determine the effect on lung function tests and to determine how well the treatment is tolerated. Patients will receive two injections under the skin at planned treatment visits. Thus they will receive a total of 6 doses of tralokinumab or inactive substance over 12 weeks of treatment period.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0247
Date of REC Opinion
6 Aug 2015
REC opinion
Further Information Favourable Opinion