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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group: Period 2 | Experimental | Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2 |
|
| Control group: Period 2 | Active Comparator | Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2 |
|
| Subjects receiving salmeterol/fluticasone propionate: Period 1 | Experimental | All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training | Drug | Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| number of subjects who achieved Total asthma Control: Period 2 | 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. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2 | 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. | Up to Week 12 |
| Time to first individual week with Total Control |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aalborg | DK-9100 | Denmark | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20298399 | Derived | Ulrik CS, Claudius BK, Tamm M, Harving H, Siersted HC, Backer V, Hellquist B, Dahl R, Hogholm A, Johnk IK. Effect of asthma compliance enhancement training on asthma control in patients on combination therapy with salmeterol/fluticasone propionate: a randomised controlled trial. Clin Respir J. 2009 Jul;3(3):161-8. doi: 10.1111/j.1752-699X.2009.00129.x. |
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| salmeterol/fluticasone propionate 50/250 µg | Drug | Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2 |
|
Time to first individual week with Total Control in treatment period 2 will be analyzed. |
| Up to Week 24 |
| Morning peak expiratory flow (PEF) | PEF is defined as a person's maximum speed of expiration and will be measured using a peak flow meter. | Up to Week 24 |
| Forced expiratory volume in one second (FEV1) | 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. | Up to Week 24 |
| Asthma symptom score | Asthma symptom score will be analyzed to check the symptom severity | Up to Week 24 |
| Number of subjects using rescue medication | Rescue medication usage will be analyzed. | Up to Week 24 |
| Number of nights with awakening due to asthma | Number of nights with awakening due to asthma will be analyzed. | Up to Week 24 |
| Asthma severity score | Asthma severity score will be analyzed | Up to Week 24 |
| Number of subjects with adverse events (AEs) | Adverse events will be observed and counted. | Up to Week 24 |
| AQLQ score | Quality of life of subjects with asthma will be analyzed. | Up to Week 24 |
| Aarhus C |
| DK-8000 |
| Denmark |
| GSK Investigational Site | Hvidovre | 2650 | Denmark |
| GSK Investigational Site | København NV | 2400 | Denmark |
| GSK Investigational Site | Næstved | 4700 | Denmark |
| GSK Investigational Site | Odense C | 5000 | Denmark |
| GSK Investigational Site | Aarau | 5000 | Switzerland |
| GSK Investigational Site | Allschwil | 4123 | Switzerland |
| GSK Investigational Site | Basel | 4001 | Switzerland |
| GSK Investigational Site | Basel | 4031 | Switzerland |
| GSK Investigational Site | Basel | 4053 | Switzerland |
| GSK Investigational Site | Basel | 4054 | Switzerland |
| GSK Investigational Site | Basel | 4058 | Switzerland |
| GSK Investigational Site | Bern | 3007 | Switzerland |
| GSK Investigational Site | Bern | 3011 | Switzerland |
| GSK Investigational Site | Bern | 3012 | Switzerland |
| GSK Investigational Site | Bever | 7502 | Switzerland |
| GSK Investigational Site | Brittnau | 4805 | Switzerland |
| GSK Investigational Site | Castione | 6532 | Switzerland |
| GSK Investigational Site | Düdingen | 3186 | Switzerland |
| GSK Investigational Site | Egg | 8132 | Switzerland |
| GSK Investigational Site | Faltigberg-Wald | 8639 | Switzerland |
| GSK Investigational Site | Horw | 6048 | Switzerland |
| GSK Investigational Site | Klosters Platz | 7250 | Switzerland |
| GSK Investigational Site | Malvaglia | 6713 | Switzerland |
| GSK Investigational Site | Massagno | 6900 | Switzerland |
| GSK Investigational Site | Pregassona | 6963 | Switzerland |
| GSK Investigational Site | Steckborn | 8266 | Switzerland |
| GSK Investigational Site | Thun | 3600 | Switzerland |
| GSK Investigational Site | Wald | 8636 | Switzerland |
| GSK Investigational Site | Wigoltingen | 8556 | Switzerland |
| GSK Investigational Site | Worb | 3076 | Switzerland |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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