A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: motivation asthma education (compliance enhancement) (Behavioral)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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.
Study design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Total asthma control
Secondary outcome: Morning Peak Expiratory Flow, Day symptom score, Rescue medication use, Number of nights on which awakening occurred because of asthma, Adverse Events, Quality of Life questionnaire, Medication compliance, Asthma severity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Copenhagen 2400, Denmark
GSK Clinical Trials Call Center, Aarhus 8000, Denmark
GSK Clinical Trials Call Center, Naestved 4700, Denmark
GSK Clinical Trials Call Center, Odense 5000, Denmark
GSK Clinical Trials Call Center, Hvidovre 2650, Denmark
GSK Clinical Trials Call Center, Aalborg 9000, Denmark
Additional Information
Starting date: September 2005
Last updated: November 9, 2007
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