KFL3502 (Version 1 (protocol version 1, 28 Sep 2015))
Research type
Research Study
Full title
A two-arm, randomised, assessor-blind, parallel group study to evaluate the effect of fluticasone/formoterol breath actuated inhaler (BAI) and Relvar Ellipta DPI on ventilation heterogeneity in subjects with partially controlled or uncontrolled asthma.
IRAS ID
192528
Contact name
Salman Siddiqui
Contact email
Sponsor organisation
Mundipharma Research Limited
Eudract number
2015-000801-38
Duration of Study in the UK
1 years, 6 months, 3 days
Research summary
The purpose of this study is to investigate the effect of fluticasone / formoterol BAI on asthma. Therefore, in this study it will be tested how well the fluticasone / formoterol BAI inhaler can help patients with asthma by comparing this treatment to Relvar® Ellipta® dry powder inhaler (DPI), which is currently available on the market. Relvar contains two medicines, fluticasone furoate (an inhaled corticosteroid, anti-inflammatory drug) and vilanterol (a long-acting beta2 agonist, bronchodilator drug) that is taken once daily for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD).
Participants with asthma who provide written consent will enter a run in period of either 2 or 4 weeks (depending on their current asthma medication). During the run in period participants will receive a medication called Seretide Accuhaler. This medication also contains an inhaled corticosteroid and long acting beta2 agonist. If after the run in period the participant meets the entry criteria they will be randomised to receive either fluticasone / formoterol BAI or Relvar for 9 weeks. During this time there will be 3 visits to their study doctor (after 4 weeks, 8 weeks and 9 weeks of treatment). At each visit tests will be undertaken including lung function tests and questionnaires about the participants’ asthma. In addition, there will be a follow up telephone call 1 week after the end of the study
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0048
Date of REC Opinion
12 May 2016
REC opinion
Further Information Favourable Opinion