Asthma
Conditions
Keywords
QoL, Asthma, asthma compliance enhancement, Salmeterol/fluticasone, Total control, SERETIDE, FEV1
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.
Interventions
DRUGsalmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.
DRUGsalmeterol/fluticasone propionate 50/250 µg
Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with persistent asthma. * Not treated with the combination of a ICS (inhaled corticosteroid)and a LABA (long-acting beta-agonist). * Female subjects must not be fertile or must use effective contraception. * Subject must be able to comply with the use of the questionnaires in the local language.
Exclusion criteria
* Known or suspected Chronic Obstructive Pulmonary Disease. * Pregnant or lactating. * Participating investigator, employee of an investigator, or family member of any of the aforementioned. * Smoking history: Pack-years \> 10 years. * Have known clinical or laboratory evidence of a serious uncontrolled systemic disease. * Known hypersensitivity to any substance contained in investigational product or as-needed medication. * Treatment with oral corticosteroid within 2 months prior to the screening visit. * Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit. * Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Asthma symptom score | Up to Week 24 | Asthma symptom score will be analyzed to check the symptom severity |
| 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. |
| 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. |
Countries
Denmark, Switzerland
Outcome results
None listed