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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group: Period 2<br>Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2 | Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training<br>* Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.<br>|
| Active Comparator: Control group: Period 2<br>Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2 | Drug: salmeterol/fluticasone propionate 50/250 µg<br>* Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2<br>|
| Experimental: Subjects receiving salmeterol/fluticasone propionate: Period 1<br>All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1 | Drug: salmeterol/fluticasone propionate 50/250 µg<br>* Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QoL, Asthma, asthma compliance enhancement, Salmeterol/fluticasone, Total control, SERETIDE, FEV1