Last updated: 11/07/2018 18:47:29
A multicentre, randomised, double-blind, double-dummy, parallel group study to compare salmeterol/fluticasone propionate combination 50/100mcg twice daily delivered via dry powder inhaler (Diskus/Accuhaler) or non-chlorofluorocarbon metered-dose inhaler in the treatment of children with asthma aged 4-11 years.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A multicentre, randomised, double-blind, double-dummy, parallel group study to compare salmeterol/fluticasone propionate combination 50/100mcg twice daily delivered via dry powder inhaler (Diskus/Accuhaler) or non-chlorofluorocarbon metered-dose inhaler in the treatment of children with asthma aged 4-11 years.
Trial description: A multicentre, randomised, double-blind, double-dummy, parallel group study to compare salmeterol/fluticasone propionate combination 50/100mcg twice daily delivered via dry powder inhaler (Diskus/Accuhaler) or non-chlorofluorocarbon metered-dose inhaler in the treatment of children with asthma aged 4-11 years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bracamonte, T.; Schauer, U.; Emeryk, A. Efficacy and safety of salmeterol/fluticasone propionate combination delivered by the Diskus (TM) or pressurised metered-dose inhaler in children with asthma. Clinical Drug Investigation 2005;25:1-11
Emeryk A, Bracamonte T, Schauer U, Balsara S, Athisegaran R. Efficacy of salmeterol/fluticasone propionate (50/100mcg/day) delivered via the Diskus and MDI in children with asthma. Eur Respir J 2003; 22 (Suppl.45): 311s (P1985).
Schauer U, Bracamonte T, Emeryk A, Balsara S, Athisegaran R. Clinical equivalence of salmeterol/fluticasone propionate combination 50/100mcg BID delivered via Diskus or CFC-free metered dose inhaler (MDI) in children with asthma. Eur Respir J 2003; 22 (Suppl.45): 311s (P1986).
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
February 2002 to October 2002
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-22-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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