Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma
Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.
Drug: FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
- FEV1, (Forced expiratory volume in the 1st second).
- Other lung function tests, AQLQ, Safety Assessments.
|Study Start Date:||April 2007|
|Study Completion Date:||January 2008|
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive FLUTIFORM® or Sertetide®. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476073
|Chesterfield, United Kingdom|
|Principal Investigator:||Dr Blagden, MD|