Status:
COMPLETED
A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 26 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2007
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00351143
Start Date
July 26 2005
End Date
June 13 2007
Last Update
September 11 2017
Active Locations (32)
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1
GSK Investigational Site
Aalborg, Denmark, DK-9100
2
GSK Investigational Site
Aarhus C, Denmark, DK-8000
3
GSK Investigational Site
Hvidovre, Denmark, 2650
4
GSK Investigational Site
København NV, Denmark, 2400