Last updated: 11/07/2018 18:51:59
A Randomized, Double-Blind, Parallel-Group Study Evaluating the Protective Effects of the Fluticasone Propionate/Salmeterol Combination Product (FSC 250/50mcg BID via DISKUS) Against Bronchospasms Induced by Activity as Measured by Exercise Challenge Testing in Adolescent and Adult Subjects who Require Chronic Inhaled Corticosteroid Therapy for the Treatment of Persistent 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, Parallel-Group Study Evaluating the Protective Effects of the Fluticasone Propionate/Salmeterol Combination Product (FSC 250/50mcg BID via DISKUS) Against Bronchospasms Induced by Activity as Measured by Exercise Challenge Testing in Adolescent and Adult Subjects who Require Chronic Inhaled Corticosteroid Therapy for the Treatment of Persistent Asthma
Trial description: A Randomized, Double-Blind, Parallel-Group Study Evaluating the Protective Effects of the Fluticasone Propionate/Salmeterol Combination Product (FSC 250/50mcg BID via DISKUS) Against Bronchospasms Induced by Activity as Measured by Exercise Challenge Testing in Adolescent and Adult Subjects who Require Chronic Inhaled Corticosteroid Therapy for the Treatment of Persistent 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:
Dorinsky P, Jones J, Kalberg C, et al. Sustained protection against activity-induced bronchospasm (AIB) during chronic treatment with the fluticasone propionate/salmeterol combination (FSC). 98 Int. Conf. Am. Thorac. Soc. (Am. Lung Assoc.) (ATS) 2002;-(:Abstr. Cd:C48-F75).
Weiler JM, Nathan RA, Rupp NT, Kalberg CJ, Emmett A, Dorinsky PM. Effect of fluticasone/salmeterol administered via a single device on exercise-induced bronchospasm in patients with persistent asthma. Annals of Allergy, Asthma, & Immunology 2005; 94: 65-72
Medical condition
Bronchospasm
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
April 2000 to March 2001
Type
Not applicable
Phase
4
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
2001-08-03
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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