Overview

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

Status:
Completed
Trial end date:
2007-06-13
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Xhance
Criteria
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.