Last updated: 11/07/2018 18:52:14
A Randomized, Double-Blind, Parallel Group, Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg twice daily Diskus Versus Fluticasone Propinate 250 mcg twice daily Diskus in Adolescents and Adults With Moderate To 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, Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg twice daily Diskus Versus Fluticasone Propinate 250 mcg twice daily Diskus in Adolescents and Adults With Moderate To Persistent Asthma
Trial description: A Randomized, Double-Blind, Parallel Group, Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg twice daily Diskus Versus Fluticasone Propinate 250 mcg twice daily Diskus in Adolescents and Adults With Moderate To 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 Yancey S Reilly D Stauffer J Edwards L Sutton L. Control of airway inflammation is maintained in asthma patients following a 60% reduction in ICS dose with fluticasone propionate/salmeterol (FSC) compared with higher dose fluticasone propionate (FP) alone. Eur. Respir. Soc. Congr. 2004; Abs No P1976.
Jarjour N, Dorinsky P, Stauffer J, et al. Control of airway inflammation in asthma patients receiving fluticasone propionate (FP)/saimeterol, FP alone or FP plus montelukast. Conference title: 62nd Annual Meeting of the American- Academy-of-Allergy-Asthma-and- Immunology, March 03 -07, 2006, Miami Beach, FL, USA, Sponsor: Amer Acad Allergy Asthma & Immunol., 2006.
Jarjour N, Dorinsky P, Stauffer J, et al. Control of airway inflammation in asthma patients receiving fluticasone propionate (FP)/salmeterol, FP alone or FP plus montelukast. Journal of Allergy & Clinical Immunology 2006; 17: S348.
Jarjour N, Dorinsky P, Stauffer J. Control of airway inflammation in asthma patients receiving fluticasone propionate (FP)/salmeterol, FP alone or FP plus montelukast. Journal of Allergy and Clinical Immunology 2006; 117: 92.
Jarjour NN, Wilson SJ, Koenig SM, et al. Control of airway inflammation maintained at a lower steroid dose with 100/50 microg of fluticasone propionate/salmeterol. Journal of Allergy & Clinical Immunology 2006; 118: 44-52.
Stauffer J, Yancey S, Waitkus-Edwards K, Edwards L, Dorinsky P. Clinical markers of worsening asthma with the fluticasone propionate/salmeterol 100/50mcg Diskus (FSC) vs fluticasone propionate (FP) 250mcg alone in patients requiring FP 250mcg BID for asthma stability. Ann. Allergy Asthma Immunol. 2004;92(1):144 Abs No P79.
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
July 2000 to July 2003
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
2003-15-07
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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