Status:
COMPLETED
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be con...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects with a documented history of persistent asthma.
- Current non-smokers.
- Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
- Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.
- Exclusion criteria:
- Subjects with significant past or present disease which which may affect their safety.
- Upper or lower respiratory tract infection within 4 weeks of screening.
- History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
- Patients taking doses of inhaled corticosteroid \>500mcg/day and patients who have changed therapy within 8 weeks of the study.
- Patients weighing less than 50kg.
Exclusion
Key Trial Info
Start Date :
May 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2007
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00347139
Start Date
May 23 2006
End Date
January 10 2007
Last Update
September 14 2017
Active Locations (7)
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1
GSK Investigational Site
Wiesbaden, Hesse, Germany, 65187
2
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, Germany, 22927
3
GSK Investigational Site
Wellington, New Zealand, 6035
4
GSK Investigational Site
Moscow, Russia, 105 077