Last updated: 11/07/2018 18:45:27
A 4-week, randomized, double-blind, placebo run-in, parallel-group study in pediatric subjects with asthma aged 4-11 years to examine the pharmacodynamics and pharmacokinetics of the fluticasone propionate (FP) and salmeterol (SALM) combination product administered twice daily via the Diskus (FP 100mcg/SALM 50mcg) and the FP Diskus (FP 100mcg)
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 4-week, randomized, double-blind, placebo run-in, parallel-group study in pediatric subjects with asthma aged 4-11 years to examine the pharmacodynamics and pharmacokinetics of the fluticasone propionate (FP) and salmeterol (SALM) combination product administered twice daily via the Diskus (FP 100mcg/SALM 50mcg) and the FP Diskus (FP 100mcg)
Trial description: A 4-week, randomized, double-blind, placebo run-in, parallel-group study in pediatric subjects with asthma aged 4-11 years to examine the pharmacodynamics and pharmacokinetics of the fluticasone propionate (FP) and salmeterol (SALM) combination product administered twice daily via the Diskus (FP 100mcg/SALM 50mcg) and the FP Diskus (FP 100mcg)
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:
Abstract: Seretide delivered via the diskus is effective in children aged 4-11 years. Schauer U , Bracamonte T, Emeryk A, Balsara S, Godwood A. 6th International Congress on Paediatric Pulmonology 2/28/2004 Lisbon Portugal
Abstract: The safety of fluticasone propionate/salmeterol diskus in pediatric patients. Stauffer, J., Schoaf, L., VanderMeer, A., House, K., and Dorinsky, P. 2003 Annual Meeting of the American College of Allergy, Asthma and Immunology 11/7/2003 New Orleans, LA; USA
Abstract: The safety of fluticasone propionate/salmeterol diskusâ® in pediatric patients ages 4 - 11 with asthma. House, Karen MS, Dorinsky, Paul M. MD, Stauffer, John MD, Schoaf, Lynne RN, and Ellsworth, Anna BS 70th Annual Meeting of the American College of Chest Physicians 10/23/2004 Seattle, WA; USA
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
July 2003 to April 2004
Type
Not applicable
Phase
1
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
2004-13-04
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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