Tralokinumab in severe asthma
Research type
Research Study
Full title
A 52-week, multicentre, randomized, double-blind, parallel-group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of tralokinumab in adults and adolescents with asthma inadequately controlled on inhaled corticosteroid plus long-acting B2-agonist (D2210C00008).
IRAS ID
162248
Contact name
Hassan Burhan
Contact email
Sponsor organisation
Astrazeneca
Eudract number
2013-005615-27
Research summary
The purpose of this trial is to investigate the safety and clinical benefit of tralokinumab treatment in asthma patients who are otherwise uncontrolled on current standard of care. In addition the trial will also assess whether levels of certain ubstances found in the body can be used to predict whether a patient will benefit from treatment with tralokinumab.
Patients who are currently treated with high dose inhaled corticosteroid and long-acting B2-agonists and are aged between 12 and 75 may be eligible to take part in the study which will last for approximately 78 weeks.
Regular visits to the clinic are required for the whole duration of the study, to assess the health of the patient, determine the effect of the drug on lung function tests and to measure levels of tralokinumab in the blood, as well as determining how well the treatment is tolerated by patients. Patients will also be issued with an electronic diary and spirometer for use at home to record lung function, asthma symptoms, use of reliever medication and compliance with investigational product in the morning and evening
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1248
Date of REC Opinion
24 Sep 2014
REC opinion
Further Information Favourable Opinion