Last updated: 11/07/2018 16:35:25
A multicentre, randomised, parallel-group open label study to assess the long term safety of fluticasone propionate 100mcg bd via the MDI and babyhaler spacer device, compared with sodium cromoglycate 5mg QDS in children aged 12-47months with documented evidence of recurrent/persistent asthma-like symptoms.
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, parallel-group open label study to assess the long term safety of fluticasone propionate 100mcg bd via the MDI and babyhaler spacer device, compared with sodium cromoglycate 5mg QDS in children aged 12-47months with documented evidence of recurrent/persistent asthma-like symptoms.
Trial description: A multicentre, randomised, parallel-group open label study to assess the long term safety of fluticasone propionate 100mcg bd via the MDI and babyhaler spacer device, compared with sodium cromoglycate 5mg QDS in children aged 12-47months with documented evidence of recurrent/persistent asthma-like symptoms.
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: A long term study comparing the safety (including growth) efficacy of fluticasone propionate 100mcg bd with sodium cromoglycate 5mg qds in asthmatic children aged 12-47 months. Hans Bisgaard David B Allen Janusz Milanowskig Kalev C Patricia Davies Lisa Willits 58th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/1/2002 New York, NY; USA
Bisgaard H, Allen D, Milanowski J, Kalev I,Willits L, Davies P. Twelve month Safety and Efficacy of Inhaled Fluticasone Propionate in Children Aged 1 to 3 years with Recurrent Wheezing. Pediatrics 2004; 113 no2 : e87-94.
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
October 1999 to March 2001
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
2001-15-03
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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