A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control

Phase 4

Completed

Interventions: Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Drug: salmeterol/fluticasone propionate 50/250 µg

Brief Summary: This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Interventional group: Period 2	salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training	Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2
Control group: Period 2	salmeterol/fluticasone propionate 50/250 µg	Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2
Subjects receiving salmeterol/fluticasone propionate: Period 1	salmeterol/fluticasone propionate 50/250 µg	All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1

Primary Outcome Measures

Name	Time	Method
number of subjects who achieved Total asthma Control: Period 2	Up to Week 24	Proportion of subjects who achieved Total Control in 7 out of the last 8 consecutive weeks in treatment period 2 with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing and compliance enhancement training compared with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing without compliance enhancement training.

Secondary Outcome Measures

Name	Time	Method
Time to first individual week with Total Control	Up to Week 24	Time to first individual week with Total Control in treatment period 2 will be analyzed.
Morning peak expiratory flow (PEF)	Up to Week 24	PEF is defined as a person's maximum speed of expiration and will be measured using a peak flow meter.
Forced expiratory volume in one second (FEV1)	Up to Week 24	FEV1 is defined as Forced Expiratory Volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function.
Asthma symptom score	Up to Week 24	Asthma symptom score will be analyzed to check the symptom severity
Number of subjects using rescue medication	Up to Week 24	Rescue medication usage will be analyzed.
Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2	Up to Week 12	Proportion of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing in treatment period 1 will be analyzed.
Number of nights with awakening due to asthma	Up to Week 24	Number of nights with awakening due to asthma will be analyzed.
Asthma severity score	Up to Week 24	Asthma severity score will be analyzed
Number of subjects with adverse events (AEs)	Up to Week 24	Adverse events will be observed and counted.
AQLQ score	Up to Week 24	Quality of life of subjects with asthma will be analyzed.