Last updated: 11/07/2018 16:15:27
A multicentre, randomised, double-blind, double-dummy, parallel group clinical trial to determine the clinical equivalence between fluticasone propionate 400?g/daily via the DiskusTM and budesonide 800?g/daily via the TurbuhalerTM administered for 5 months in pre-pubescent children aged 4 to 12 ...
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 clinical trial to determine the clinical equivalence between fluticasone propionate 400?g/daily via the DiskusTM and budesonide 800?g/daily via the TurbuhalerTM administered for 5 months in pre-pubescent children aged 4 to 12 ...
Trial description: A multicentre, randomised, double-blind, double-dummy, parallel group clinical trial to determine the clinical equivalence between fluticasone propionate 400?g/daily via the DiskusTM and budesonide 800?g/daily via the TurbuhalerTM administered for 5 months in pre-pubescent children aged 4 to 12 ...
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, Spier S, Manjra A Versteegh FGA, Mark S, Zhanq P. Efficacy and safety of high-dose inhaled steroids in children with asthma: A comparison of fluticasone propionate with budesonide. J. PEDIATR. 1999;134(4):422-427
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
April 1996 to May 1997
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
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
1997-15-05
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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