Status:
COMPLETED
Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-nai...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of asthma
- Reversibility \>12% after inhalation of 200 µg Salbutamol
- willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis
- 80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria
- Exclusion criteria:
- Change of asthma medication during the last 4 weeks
- Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months
- upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period
- Non compliance with use of Discus, PEF-meter and incomplete diary card data
Exclusion
Key Trial Info
Start Date :
May 17 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2007
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00363480
Start Date
May 17 2006
End Date
September 14 2007
Last Update
March 9 2018
Active Locations (32)
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1
GSK Investigational Site
Erlangen, Bavaria, Germany, 91052
2
GSK Investigational Site
Kaufbeuren, Bavaria, Germany, 87600
3
GSK Investigational Site
Landsberg am Lech, Bavaria, Germany, 86899
4
GSK Investigational Site
Munich, Bavaria, Germany, 80335