ELIOT – Easy, Low Instruction Over Time v1.0
Research type
Research Study
Full title
A 12 Week, Randomized, Open-Label, Parallel Group Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® (160/4.5 and 320/9 mcg) as Compared to SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as Treatment for Adult Patients with Asthma (The Easy Low Instruction Over Time [ELIOT] Study)
IRAS ID
144550
Contact name
David Price
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products, R&D, Inc.
Eudract number
2013-004630-14
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Incorrect usage of inhaler devices is associated with worsened asthma outcomes. Designing easier to use inhaler devices could improve adverse asthma outcomes. This is a UK based interventional study evaluating how well patients can learn to use and continue correctly using an inhaler after using it daily for 12 weeks. The investigational product is the Spiromax©, a new inhaler device. The control is the Turbohaler©, an inhaler commonly prescribed to patients with asthma. Patients between 18 and 75 years of age, who have asthma and who have not used a Turbohaler in the last six months will be eligible for the study. Recruitment will be done through GP practices.
The study consists of two stages. Stage 1 will involve a visit to collect health information, assess current inhaler technique and provide training in the use of the investigative and control devices. The training devices will be empty. Patients with at least one error in the usage of their current inhaler will be invited to participate in Stage 2. Stage 2 is a 12 week, randomised controlled trial (RCT) to evaluate how well patients can maintain correct use of the Spiromax versus the Turbohaler. During the RCT, patients will receive the inhaled corticosteroid budesonide and long acting beta agonist formoterol at an equivalent dose to their normal prescription via the Spiromax or the Turbohaler. Patients will be contacted by telephone at week 4, 8 and 12 of the RCT to assess asthma symptoms and possible adverse events. For patients participating in both stages, the study will comprise two visits (firstly a combined stage 1 visit and stage 2 initiation visit and secondly a closing visit at the end of the 12 week RCT) and three short telephone interviews. Maximum study duration per patient is 12 weeks (-7 to +3 days).
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0468
Date of REC Opinion
23 Jan 2014
REC opinion
Further Information Favourable Opinion