Last updated: 11/07/2018 16:59:59
A multi-centre, randomised, double-blind, placebo-controlled parallel group study to determine the efficacy and safety of inhaled fluticasone propionate 100mg bd and 250mg bd delivered via the Babyhaler™ spacer device in the management of asthma symptoms in children aged 12–47 months inclusive.
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 multi-centre, randomised, double-blind, placebo-controlled parallel group study to determine the efficacy and safety of inhaled fluticasone propionate 100mg bd and 250mg bd delivered via the Babyhaler™ spacer device in the management of asthma symptoms in children aged 12–47 months inclusive.
Trial description: A multi-centre, randomised, double-blind, placebo-controlled parallel group study to determine the efficacy and safety of inhaled fluticasone propionate 100mg bd and 250mg bd delivered via the Babyhaler™ spacer device in the management of asthma symptoms in children aged 12–47 months inclusive.
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:
Price M, Mahajan P, Maden C, Thwaites R. Parenteral preference for the Babyhaler(TM) inhalation device and its ease of use in the administration of inhaled asthma medication to pre-school children. EUR. RESPIR. J. 1997;10 SUPPL. 25:81S.
Price MJ, Mahajan P, Maden C, Wilcox TK ,Thwaites RMA. Impact of inhaled fluticasone propionate on parental sleep disturbance and perception of asthma symptoms in pre-school children. J. ALLERGY CLIN. IMMUNOL. 1998;101(1 PART 2):S151.
Roorda RJ, Mezei G, Bisgaard H, Maden C. Response of pre-school children with asthma symptoms to inhaled fluticasone propionate: Results from two multicentre studies . AM. J. RESPIR. CRIT. CARE MED. 1999;159(3 PART 2):139.
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
February 1995 to July 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
1996-31-07
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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