Flutiform® Change and Step-Down Study (FFLU-X study) v.1.0
Research type
Research Study
Full title
A guideline approach to therapy step-down utilising Flutiform®: change and step-down (FFLU-X study)
IRAS ID
145576
Contact name
David Price
Contact email
Sponsor organisation
University of Aberdeen and Research in Real-Life Ltd
Eudract number
2013-005365-39
Research summary
The aim of this study is to compare two licensed asthma inhalers and to then evaluate the safety of reducing treatment when patient’s asthma is in control. The inhalers used in this study are the Seretide® 250 Evohaler®, which is widely used in UK, and a recently licensed inhaler called Flutiform®. National guidelines recommend that asthma medication should be increased when patients are experiencing worsening of their asthma, and reduced when asthma is in control. However, it is likely that in daily clinical practice some patients are over-treated. It is therefore necessary to conduct more studies which demonstrate that reducing treatment dosage can be done safely.\n\nThis study has two phases. In the first phase we aim to recruit 224 patients through approximately 40 clinics in the UK. One third of these patients will be selected in random to use the high dosage Seretide® 250 Evohaler® and two thirds will use high dose Flutiform® 250 inhaler for 12 weeks. At the end of phase 1 we will compare how well asthma was controlled between the two groups.\n\nAfter phase 1 those patients who used Flutiform and did not have any problems with their asthma can participate in phase 2. In phase 2 half of the patients will stay on high dosage Flutiform 250 and half will be switched to the medium dosage Flutiform 125 inhaler. At the end of phase 2 we will compare asthma control between the two groups.\n\nThis study will be conducted by Research in Real Life Ltd (Cambridge, UK) with partial funding from Napp Pharmaceuticals Ltd. The estimated total duration of the study is 18 months and each patient will spend a maximum of 6 months in the study.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/0057
Date of REC Opinion
20 Mar 2014
REC opinion
Further Information Favourable Opinion