Asthma Clinical Trial
Official title:
A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down
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.
This study has two phases. In the first phase the investigators aim to recruit 224 patients
through approximately 40 clinics in the UK and Ireland. 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 the investigators will
compare how well asthma was controlled between the two groups.
After 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 the investigators will compare asthma control between the two groups.
This 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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