Last updated: 11/07/2018 16:34:51
A Randomized, Double-Blind, Paralled-Group, Placebo-Controlled 12 Week Trial of Inhaled Fluticasone Propionate 88mcg Twice Daily versus Placebo in Propellant GR106642X in Pediatric Subjects 4 to 11 years of age with 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 Randomized, Double-Blind, Paralled-Group, Placebo-Controlled 12 Week Trial of Inhaled Fluticasone Propionate 88mcg Twice Daily versus Placebo in Propellant GR106642X in Pediatric Subjects 4 to 11 years of age with Asthma
Trial description: A Randomized, Double-Blind, Paralled-Group, Placebo-Controlled 12 Week Trial of Inhaled Fluticasone Propionate 88mcg Twice Daily versus Placebo in Propellant GR106642X in Pediatric Subjects 4 to 11 years of age with 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:
Abstract: A side-by-side comparison of the efficacy and safety of fluticasone propionate/salmeterol diskus with fluticasone propionate diskus and hfa in 4-11 year-olds with asthma. Scott, C., Schoaf, L., Wu, W. PhD, Ellsworth, A., and Crim, C. MD RTP NC 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Fluticasone propionate hfa improves asthma control in children aged 4 to 11 years with asthma. A. Levya J. Condemib L. Landwehrc D. Clementsd C. SCottd W. Wud C. Crimd 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
Abstract: Fluticasone propionate hfa improves asthma control in children aged 4 to 11 years with asthma. Levy, A. 1, Condemi, J. 2, Landwehr, L. 3, Clements, D. 4, Scott, C. 4, Wu, W. 4, and Crim, C. 4 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: Fluticasone propionate hfa improves asthma control in pre-school age children with asthma. Sugerman, R. W., Teper, A. M., Girardi, G., 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
Abstract: Safety of fluticasone propionate hfa in treating children 4-11 years of age with asthma. Given, J. 1, Kent, E. 2, Gossage, D. 3, Clements, D. 4, Scott, C. 4, Wu, W. 4, and Crim, C. 4 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: Safety of fluticasone propionate hfa in treating children 4-11 years of age with asthma. Given, J., Kent, E., Gossage, D., Clements, D., Scott, C., Wu, W., and Crim, C. 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, 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 Children Aged 4 to 11 Years with Asthma. A Levy, J Condemi, L. Landwehr, D Clements, C Scott, W Wu, C Crim, J. Allergy Clin. Immunol. 2004;113(2 SUPPL.):S113 Abs No 347.
Safety of Fluticasone Propionate HFA in Treating Children 4-11 Years of Age with Asthma J Given, E Kent, D Gossage, D Clements, C Scott, W Wu, C Crim, J. Allergy Clin. Immunol. 2004;113(2): Abs No 346.
Scott C, Wu W, Ellsworth A. Efficacy and safety of fluticasone propioante/salmeterol DISKUS and fluticasone propionate DISKUS and HFA in children. European Respiratory Journal Supplement 2005; 26: 161 (plus poster) abstr. P1057.
Scott, C., Schoaf, L., Wu, W., et al. A Side-By-Side Comparison of the Efficacy and Safety of Fluticasone Propionate/Salmeterol DISKUS with Fluticasone Propionate DISKUS and HFA in 4-11 Year-Olds with Asthma [C47] [Poster: A7]. Available from http://www.abstracts2view.com/ats05/ [Accessed June 2005]
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
October 2001 to December 2002
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
2002-02-12
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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