Last updated: 11/07/2018 17:00:32
A randomised, double-blind, parallel-group clinical trial to establish the safety and efficacy of nebulised fluticasone propionate 1mg twice daily compared with oral prednisolone administered for 7 days to pre-school children aged 48 months or less with an acute exacerbation of asthma.
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, parallel-group clinical trial to establish the safety and efficacy of nebulised fluticasone propionate 1mg twice daily compared with oral prednisolone administered for 7 days to pre-school children aged 48 months or less with an acute exacerbation of asthma.
Trial description: A randomised, double-blind, parallel-group clinical trial to establish the safety and efficacy of nebulised fluticasone propionate 1mg twice daily compared with oral prednisolone administered for 7 days to pre-school children aged 48 months or less with an acute exacerbation of asthma.
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:
Francis P, Geelhoed G, Harris MA, Morton J, Efthimiou J, Barnacle H. Effect of nebulised fluticasone propionate 1mg twice daily compared with oral prednisolone in pre-school children aged 48 months or less with an acute exacerbation of asthma. Eur Respir J 1997; 10 suppl 25: 275s.
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
October 1995 to May 1996
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
1996-21-05
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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