Status:
COMPLETED
Viapaed Study In Children And Adolescents With Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
Brief Summary
Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Children aged 4 to 16 years with an established history of perennial asthma.
- Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
- 15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
- Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
- Subjects/guardians who have given written informed consent to participate in the study.
- Subjects /guardians who are able to understand and complete a diary record card (DRC).
- Subjects who are able to use a Mini-Wright Peak Flow meter.
- Sexually active female adolescents must use adequate contraception.
- Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.
Exclusion
Key Trial Info
Start Date :
November 4 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2007
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00315744
Start Date
November 4 2004
End Date
April 12 2007
Last Update
October 19 2017
Active Locations (98)
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1
GSK Investigational Site
Bad Krozingen, Baden-Wurttemberg, Germany, 79189
2
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, Germany, 74357
3
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany, 77955
4
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, Germany, 69115