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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: salmeterol/fluticasone propionate 50/250 µg; Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training

Study type: Interventional

Funder types: Industry

Identifiers

NCT00351143

ACE104325

Details and patient eligibility

About

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.

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 3 patient groups

Interventional group: Period 2

Experimental group

Description:

Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2

Treatment:

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

Control group: Period 2

Active Comparator group

Description:

Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2

Treatment:

Drug: salmeterol/fluticasone propionate 50/250 µg

Subjects receiving salmeterol/fluticasone propionate: Period 1

Experimental group

Description:

All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1

Treatment:

Drug: salmeterol/fluticasone propionate 50/250 µg