Last updated: 11/07/2018 18:47:46
A randomized, double-blind, placebo-controlled, parallel-group, 12 week trial evaluating the safety and efficacy of the fluticasone propionate/salmeterol DISKUS combination product 250/50mcg once daily versus fluticasone propionate 250mcg once daily versus fluticasone propionate/salmeterol 100/50mcg twice daily versus placebo in symptomatic adolescent and adult subjects with asthma that is not controlled on short acting beta agonist therapy
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, placebo-controlled, parallel-group, 12 week trial evaluating the safety and efficacy of the fluticasone propionate/salmeterol DISKUS combination product 250/50mcg once daily versus fluticasone propionate 250mcg once daily versus fluticasone propionate/salmeterol 100/50mcg twice daily versus placebo in symptomatic adolescent and adult subjects with asthma that is not controlled on short acting beta agonist therapy
Trial description: A randomized, double-blind, placebo-controlled, parallel-group, 12 week trial evaluating the safety and efficacy of the fluticasone propionate/salmeterol DISKUS combination product 250/50mcg once daily versus fluticasone propionate 250mcg once daily versus fluticasone propionate/salmeterol 100/50mcg twice daily versus placebo in symptomatic adolescent and adult subjects with asthma that is not controlled on short acting beta agonist therapy
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: Effectiveness and safety of fluticasone propionate/salmeterol 250150 mcg administered once daily to patients with persistent asthma. P. Dorinsky, E. Kerwin L. Schoaf A. Ellsworth K. House 14th Annual Congress of the European Respiratory Society 9/4/2004 Glasgow Scotland
Abstract: The safety and effectiveness of once daily administration of fluticasone propionate/salmeterol 250/150ug. P. Dorinsky L.Schoaf K. House A. VanderMeer . 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco CA
Abstract: The safety and effectiveness of once daily administration of fluticasone propionate/salmeterol 250/50mcg. Dorinsky, P., Schoaf, L., House, K., and VanderMeer, A. 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: The safety and effectiveness of once daily administration of fluticasone propionate/salmeterol 250/50mcg. Dorinsky, P., Schoaf, L., House, K., and VanderMeer, A. 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
Dorinsky P, Kerwin E, Schoaf L, Ellsworth A, House KM. the effectiveness and safety of fluticasone propionate/salmeterol 250/50mcg administered once daily to patients with persistent asthma.
Dorinsky P, Schoaf L, House K, Ellsworth A. The efficacy and safety of FP/salmeterol 250/50mcg once daily compared with FP/salmeterol 100/50mcg twice daily. Am J Respir Crit Care Med 2004; 169 (7): A149
Dorinsky P, Schoaf L, House K, Ellsworth A. The efficacy and safety of fluticasone propionate/salmeterol 250/50mcg once daily compared with fluticasone propionate/salmeterol 100/50mcg twice daily. Am. Thorac. Soc. 100 Int. Conf. 2004;A149 Abs No A53:C77.
Dorinsky P, Schoaf L, House K, VanderMeer A. The safety and effectiveness of once daily administration of fluticasone propionate/salmeterol 250/50mcg. J Allergy Clin Immunol 2004;113(2):Abs No 367.
Harnest U, Price D, Howes T, Sussman G. Comparison of mometasone furoate dry powder inhaler and fluticasone propionate dry powder inhaler in patients with moderate to severe persistent asthma requiring high-dose inhaled corticosteroid therapy: findings from a noninferiority trial. J Asthma 2008;45(3):215–20.
Kerwin EM, Nathan RA, Meltzer EO, et al. Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respir Med 2008;102(4):495–504.
The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. Malone, R., LaForce, C., Nimmagadda, S., Schoaf, L., House, K., Ellsworth, A., and Dorinsky, P. Ann Allergy Asthma Immunol 2005; 95(1):66-71
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
November 2001 to June 2003
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
2003-06-06
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website