A Randomized, Open Label Comparative Study to Determine the Proportion of Asthma Patients on SERETIDE Diskus 50/250 mcg b.i.d. Achieving Total Control When Given Medication and Compliance Enhancement Training Compared to Those Receiving Medication Only
Overview
- Phase
- Phase 4
- Intervention
- salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 274
- Locations
- 1
- Primary Endpoint
- number of subjects who achieved Total asthma Control: Period 2
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Interventional group: Period 2
Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2
Intervention: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Control group: Period 2
Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2
Intervention: salmeterol/fluticasone propionate 50/250 µg
Subjects receiving salmeterol/fluticasone propionate: Period 1
All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1
Intervention: salmeterol/fluticasone propionate 50/250 µg
Outcomes
Primary Outcomes
number of subjects who achieved Total asthma Control: Period 2
Time Frame: 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 Outcomes
- Time to first individual week with Total Control(Up to Week 24)
- Morning peak expiratory flow (PEF)(Up to Week 24)
- Forced expiratory volume in one second (FEV1)(Up to Week 24)
- Asthma symptom score(Up to Week 24)
- Number of subjects using rescue medication(Up to Week 24)
- 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)
- Number of nights with awakening due to asthma(Up to Week 24)
- Asthma severity score(Up to Week 24)
- Number of subjects with adverse events (AEs)(Up to Week 24)
- AQLQ score(Up to Week 24)