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

GlaxoSmithKline274 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

274

Conditions

Asthma

Interventions

salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement trainingDRUG

Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.

salmeterol/fluticasone propionate 50/250 µgDRUG

Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

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.

Time frame: Up to Week 24

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Week 24

Asthma symptom score

Asthma symptom score will be analyzed to check the symptom severity

Time frame: Up to Week 24

Data from ClinicalTrials.gov

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