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Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily.
Respir Med. 2008 Apr; 102(4):495-504.RM

Abstract

BACKGROUND

The twice daily administration of an inhaled corticosteroid (ICS) and long-acting beta(2)-agonist (LABA) has been shown to be effective in achieving asthma control. The once daily administration of an ICS/LABA may be a treatment option for some patients.

OBJECTIVE

To assess the effectiveness of fluticasone propionate (FP)/salmeterol via a single inhaler (FSC) administered once daily compared with FP once daily, FSC twice daily, or placebo.

METHODS

A 12-week, randomized, double-blind multicenter study conducted in 844 patients > or = 12 years of age who were symptomatic while using a short-acting beta(2)-agonist alone. Blinded treatments included: FSC 250/50 mcg once daily in the evening (FSC 250/50 QD), FP 250 mcg once daily in the evening (FP 250 QD), FSC 100/50 mcg twice daily (FSC 100/50 mcg BID), or placebo. All treatments were delivered via the Diskus device.

RESULTS

All treatments demonstrated greater improvements in efficacy measures compared with placebo. Overall, the greatest improvements were observed in the patients receiving FSC, either once or twice daily, compared with the FP 250 QD group. The two FSC treatments were similar except that QD dosing did not maintain improvements in lung function for 24h compared with twice daily dosing. All treatments were well tolerated. No suppression of HPA axis, as assessed by 24-h urinary cortisol excretion, was observed in any of the active treatment groups.

CONCLUSION

In patients symptomatic on a short-acting beta(2)-agonist alone, FSC 100/50 mcg BID was shown to provide better efficacy than a higher strength (FSC 250/50 mcg) administered once daily. However, a once daily regimen was effective and may be a valuable treatment option for some patients. Registered at (http://ctr.gsk.co.uk/welcome.asp) (SAS30022).

Authors+Show Affiliations

Clinical Research Institute of Southern Oregon, Medford, OR 97504, USA. ekerwin@allergyasthmaso.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18206361

Citation

Kerwin, Edward M., et al. "Efficacy and Safety of Fluticasone Propionate/salmeterol 250/50 Mcg Diskus Administered once Daily." Respiratory Medicine, vol. 102, no. 4, 2008, pp. 495-504.
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.
Kerwin, E. M., Nathan, R. A., Meltzer, E. O., Ortega, H. G., Yancey, S. W., Schoaf, L., & Dorinsky, P. M. (2008). Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respiratory Medicine, 102(4), 495-504. https://doi.org/10.1016/j.rmed.2007.12.002
Kerwin EM, et al. Efficacy and Safety of Fluticasone Propionate/salmeterol 250/50 Mcg Diskus Administered once Daily. Respir Med. 2008;102(4):495-504. PubMed PMID: 18206361.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. AU - Kerwin,Edward M, AU - Nathan,Robert A, AU - Meltzer,Eli O, AU - Ortega,Hector G, AU - Yancey,Steven W, AU - Schoaf,Lynne, AU - Dorinsky,Paul M, Y1 - 2008/02/21/ PY - 2007/09/07/received PY - 2007/11/30/revised PY - 2007/12/03/accepted PY - 2008/1/22/pubmed PY - 2008/10/1/medline PY - 2008/1/22/entrez SP - 495 EP - 504 JF - Respiratory medicine JO - Respir Med VL - 102 IS - 4 N2 - BACKGROUND: The twice daily administration of an inhaled corticosteroid (ICS) and long-acting beta(2)-agonist (LABA) has been shown to be effective in achieving asthma control. The once daily administration of an ICS/LABA may be a treatment option for some patients. OBJECTIVE: To assess the effectiveness of fluticasone propionate (FP)/salmeterol via a single inhaler (FSC) administered once daily compared with FP once daily, FSC twice daily, or placebo. METHODS: A 12-week, randomized, double-blind multicenter study conducted in 844 patients > or = 12 years of age who were symptomatic while using a short-acting beta(2)-agonist alone. Blinded treatments included: FSC 250/50 mcg once daily in the evening (FSC 250/50 QD), FP 250 mcg once daily in the evening (FP 250 QD), FSC 100/50 mcg twice daily (FSC 100/50 mcg BID), or placebo. All treatments were delivered via the Diskus device. RESULTS: All treatments demonstrated greater improvements in efficacy measures compared with placebo. Overall, the greatest improvements were observed in the patients receiving FSC, either once or twice daily, compared with the FP 250 QD group. The two FSC treatments were similar except that QD dosing did not maintain improvements in lung function for 24h compared with twice daily dosing. All treatments were well tolerated. No suppression of HPA axis, as assessed by 24-h urinary cortisol excretion, was observed in any of the active treatment groups. CONCLUSION: In patients symptomatic on a short-acting beta(2)-agonist alone, FSC 100/50 mcg BID was shown to provide better efficacy than a higher strength (FSC 250/50 mcg) administered once daily. However, a once daily regimen was effective and may be a valuable treatment option for some patients. Registered at (http://ctr.gsk.co.uk/welcome.asp) (SAS30022). SN - 0954-6111 UR - https://www.unboundmedicine.com/medline/citation/18206361/Efficacy_and_safety_of_fluticasone_propionate/salmeterol_250/50_mcg_Diskus_administered_once_daily_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(07)00484-2 DB - PRIME DP - Unbound Medicine ER -