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Salmeterol Diskus® in Pediatric Patients Ages 4 –11 with Asthma
October 2004, Vol 126, No. 4_MeetingAbstracts Abstract: Poster Presentations | October 2004
The Safety of Fluticasone propionate/Salmeterol Diskus® in Pediatric Patients Ages 4 –11 with Asthma Karen House, MS; Paul M. Dorinsky, MD*; John Stauffer, MD; Lynne Schoaf, RN; Anna Ellsworth, BS GlaxoSmithKline, Research Triangle Park, NC Chest Chest. 2004;126(4_MeetingAbstracts):911S. doi:10.1378/chest.126.4_MeetingAbstracts.911S-a
Abstract PURPOSE: Treatment options for asthma are limited for patients 4-11 years of age. Current guidelines recommend adding an inhaled long-acting beta2-agonist to an inhaled corticosteroid (ICS), as a preferred option versus increasing the ICS dose, thus ensuring the lowest effective dose of ICS is used. Hence, a clinical study was conducted to evaluate the safety of fluticasone propionate/salmeterol 100/50mcg (FSC) BID compared with fluticasone propionate (FP) 100mcg BID, both via Diskus®, in patients 4-11 years of age with asthma. METHODS: A 12-week, randomized, double-blind, parallel-group study was conducted in 40 patients 4 and 5 years of age, and 163 patients 6 to 11 years of age with asthma, who were symptomatic on an ICS. RESULTS: No patient had an abnormal clinically significant ECG during treatment. CONCLUSION: This study demonstrated that FSC 100/50mcg via Diskus twice daily has a favorable risk/benefit profile in patients 4-11 years of age with asthma and a similar safety profile to FP 100mcg Diskus twice daily. CLINICAL IMPLICATIONS: FSC 100/50mcg via Diskus twice daily provides added clinical benefit in pediatric patients 4-11 years of age with asthma indicating that treatment of the two main components of asthma (inflammation and smooth muscle dysfunction) in children is more effective than treatment of a single component (i.e., inflammation) alone. (SAS30031). DISCLOSURE: P.M. Dorinsky, None. Wednesday, October 27, 2004 12:30 PM - 2:00 PM
The Safety of Fluticasone propionate/Salmeterol Diskus® in Pediatric Patients Ages 4 –11 with Asthma Karen House, MS; Paul M. Dorinsky, MD*; John Stauffer, MD; Lynne Schoaf, RN; Anna Ellsworth, BS GlaxoSmithKline, Research Triangle Park, NC Chest Chest. 2004;126(4_MeetingAbstracts):911S. doi:10.1378/chest.126.4_MeetingAbstracts.911S-a
Abstract PURPOSE: Treatment options for asthma are limited for patients 4-11 years of age. Current guidelines recommend adding an inhaled long-acting beta2-agonist to an inhaled corticosteroid (ICS), as a preferred option versus increasing the ICS dose, thus ensuring the lowest effective dose of ICS is used. Hence, a clinical study was conducted to evaluate the safety of fluticasone propionate/salmeterol 100/50mcg (FSC) BID compared with fluticasone propionate (FP) 100mcg BID, both via Diskus®, in patients 4-11 years of age with asthma. METHODS: A 12-week, randomized, double-blind, parallel-group study was conducted in 40 patients 4 and 5 years of age, and 163 patients 6 to 11 years of age with asthma, who were symptomatic on an ICS. RESULTS: No patient had an abnormal clinically significant ECG during treatment. CONCLUSION: This study demonstrated that FSC 100/50mcg via Diskus twice daily has a favorable risk/benefit profile in patients 4-11 years of age with asthma and a similar safety profile to FP 100mcg Diskus twice daily. CLINICAL IMPLICATIONS: FSC 100/50mcg via Diskus twice daily provides added clinical benefit in pediatric patients 4-11 years of age with asthma indicating that treatment of the two main components of asthma (inflammation and smooth muscle dysfunction) in children is more effective than treatment of a single component (i.e., inflammation) alone. (SAS30031). DISCLOSURE: P.M. Dorinsky, None. Wednesday, October 27, 2004 12:30 PM - 2:00 PM