Last updated: 11/07/2018 16:55:59
Open-Label Extension of a Randomized, Double-Blind, Parallel-Group Trial Assessing the Efficacy and Safety of FIuticasone Propionate via the Multi-Dose Powder Inhaler 100mcg BID, 200mcg QD, and Placebo in Subjects Aged 4 to 11 Years With Chronic Asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open-Label Extension of a Randomized, Double-Blind, Parallel-Group Trial Assessing the Efficacy and Safety of FIuticasone Propionate via the Multi-Dose Powder Inhaler 100mcg BID, 200mcg QD, and Placebo in Subjects Aged 4 to 11 Years With Chronic Asthma
Trial description: Open-Label Extension of a Randomized, Double-Blind, Parallel-Group Trial Assessing the Efficacy and Safety of FIuticasone Propionate via the Multi-Dose Powder Inhaler 100mcg BID, 200mcg QD, and Placebo in Subjects Aged 4 to 11 Years With Chronic 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:
LaForce, Craig F MD ; Pearlman, David S MD ; Ruff, Michael E MD ; Silvers, William S MD ; Weinstein, Steven W MD; Clements, Diane S; Brown, Alison; Duke, Susan MS; Harding, Stuart M MD ; House, Karen W MS Efficacy and safety of dry powder fluticasone propionate in children with persistent asthma. Annals of Allergy, Asthma, & Immunology. 85(5):407-415, November 2000. (This publication contains the results of both the 12 week randomized, double-blind, parallel-group, placebo-controlled, multicentre trial which compared the efficacy and safety of fluticasone propionate (FP) 100mcg BID, FP 200mcg QD, and placebo and the 52 week open labeled extension reported here).
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
February 1995 to April 1997
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
1997-05-04
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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