Last updated: 11/07/2018 17:05:04
A randomised, double-blind, double-dummy, parallel group, multicentre study to compare the effect on growth measured by stadiometry of fluticasone propionate (100µg bd) administered via DISKUS™ with budesonide (200µg bd) administered via Turbuhaler in prepubescent children.
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 randomised, double-blind, double-dummy, parallel group, multicentre study to compare the effect on growth measured by stadiometry of fluticasone propionate (100µg bd) administered via DISKUS™ with budesonide (200µg bd) administered via Turbuhaler in prepubescent children.
Trial description: A randomised, double-blind, double-dummy, parallel group, multicentre study to compare the effect on growth measured by stadiometry of fluticasone propionate (100µg bd) administered via DISKUS™ with budesonide (200µg bd) administered via Turbuhaler in prepubescent children.
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:
Ferguson AC, Van Bever HP, Teper AM, Lasytsya OI, Whitehead PJ. Fluticasone propionate 100mcg (FP100) has significantly less effect than budesonide 200mcg bd (BUD200) on childhood growth over 1 year of treatment in asthmatics. Eur Respir J 2002; 20 (suppl 38): 219s (abs no 1447).
Ferguson AC, Van Bever HP, Teper AM, Lasytsya OI, Whitehead PJ. Significantly reduced growth velocity over 1 year with budesonide 200mcg bd (BUD200) compared to fluticasone propionate 100mcg (FP100) in children with asthma.
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
September 1999 to November 2001
Type
Not applicable
Phase
4
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
2001-05-11
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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