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.