Last updated: 11/07/2018 16:35:41
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Safety and Efficacy Study of Fluticasone Propionate 88mcg BID Versus Placebo BID delivered via HFA MDI and a valved holding chamber with facemask in Pediatric Subjects with Asthma age 12 months to 47 months.
Clinicaltrials.gov ID
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EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Safety and Efficacy Study of Fluticasone Propionate 88mcg BID Versus Placebo BID delivered via HFA MDI and a valved holding chamber with facemask in Pediatric Subjects with Asthma age 12 months to 47 months.
Trial description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Safety and Efficacy Study of Fluticasone Propionate 88mcg BID Versus Placebo BID delivered via HFA MDI and a valved holding chamber with facemask in Pediatric Subjects with Asthma age 12 months to 47 months.
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: Fluticasone propionate hfa mdi (fp-hfa) provides comparable improvement in asthma control to the cfc mdi formulation (fp-cfc) in pre-school age children with asthma. Scott, C., Kleha, J., Wu, W., and Crim, C. RTP NC 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Safety profile of fluticasone propionate hfa in pre-school age children with asthma. Qaqundah, P. Y., Maspero, J., Ceruti, E., Scott, C. A., Clements, D. S., Wu, W., and Crim, C. 61st Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/18/2005 San Antonio, TX; USA
Fluticasone Propionate HFA Improves Asthma Control in Pre-School Age Children with Asthma. R Sugerman, A Teper, G Girardi, C Scott, D Clements, W Wu, C Crim. Journal of Allergy and Clinical Immunology, Volume 115, Issue 2, Supplement 1, February 2005, Pages 4-5
Safety Profile of Fluticasone Propionate HFA in Pre-School Age Children with Asthma. P Qaqundah, J Maspero, E Ceruti, C Scott, D Clements, W Wu, C Crim. Journal of Allergy and Clinical Immunology, Volume 115, Issue 2, Supplement 1, February 2005, Page 211
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
August 2002 to April 2004
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
2004-29-04
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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