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Efficacy and tolerability of salmeterol/fluticasone propionate versus fluticasone propionate in asthma patients: a randomized, double-blind study.
Chang Gung Med J. 2011 Jul-Aug; 34(4):382-94.CG

Abstract

BACKGROUND

A combination of salmeterol and fluticasone propionate (SAL/FP) has been shown to be effective in the treatment of asthma. We compared the efficacy and tolerability of SAL/FP (50/250 μg) with fluticasone propionate (FP) 250 μg administrated twice daily for 2 weeks in treating patients with mild to moderate asthma.

METHODS

This was a randomized, double-blind study in adult patients with symptomatic asthma that was not controlled by 1000 μg/d inhaled corticosteroids (ICS) alone. 48 asthmatics were randomized to receive 2 inhalations of SAL/FP 50/250 μg bis in die (BID) or 2 inhalations of FP 250 μg BID, both delivered via Accuhaler device, for 2 weeks. The primary objective was the mean change from baseline in the mean morning peak expiratory flow (PEF) over the two week period. Other parameters included lung function, daily asthma symptom scores, evening PEF, percentage of days free of rescue medication use and daily rescue medication use. Tolerability was assessed by adverse events spontaneously elicited at clinic visits.

RESULTS

46 patients provided evaluable efficacy for analysis. The morning PEF improved significantly throughout the two weeks of treatment compared with baseline in the SAL/FP group. Mean morning PEF was 23.0 L/min higher in SAL/FP group than in FP group (p = 0.013). The change of forced expiratory volume in one second (FEV1) from baseline was greater in SAL/FP group compared to FP group (p = 0.048). There were similar effects on day-time and night-time symptom scores, percentage symptom free days and nights and usage of salbutamol. 70.8% of the patients receiving SAL/FP were satisfied with the treatment, while only 26.1% of patients receiving FP alone were (p = 0.020). No death or acute exacerbation occurred.

CONCLUSION

SAL/FP 50/250 μg was safe and effective, and had a high level of patient satisfaction resulting in significantly greater increases in morning PEF and FEV1 compared to the use of FP 250 μg alone.

Authors+Show Affiliations

Department of Thoracic Medicine, Chang Gung Memorial Hospital at Linkuo, Chang Gung University College of Medicine, Taoyuan, Taiwan.No affiliation info availableNo 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

21880193

Citation

Lee, Yu-Sung, et al. "Efficacy and Tolerability of Salmeterol/fluticasone Propionate Versus Fluticasone Propionate in Asthma Patients: a Randomized, Double-blind Study." Chang Gung Medical Journal, vol. 34, no. 4, 2011, pp. 382-94.
Lee YS, Lin HC, Huang CD, et al. Efficacy and tolerability of salmeterol/fluticasone propionate versus fluticasone propionate in asthma patients: a randomized, double-blind study. Chang Gung Med J. 2011;34(4):382-94.
Lee, Y. S., Lin, H. C., Huang, C. D., Lee, K. Y., Liu, C. Y., Yu, C. T., Wang, C. H., & Kuo, H. P. (2011). Efficacy and tolerability of salmeterol/fluticasone propionate versus fluticasone propionate in asthma patients: a randomized, double-blind study. Chang Gung Medical Journal, 34(4), 382-94.
Lee YS, et al. Efficacy and Tolerability of Salmeterol/fluticasone Propionate Versus Fluticasone Propionate in Asthma Patients: a Randomized, Double-blind Study. Chang Gung Med J. 2011 Jul-Aug;34(4):382-94. PubMed PMID: 21880193.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of salmeterol/fluticasone propionate versus fluticasone propionate in asthma patients: a randomized, double-blind study. AU - Lee,Yu-Sung, AU - Lin,Horng-Chyuan, AU - Huang,Chien-Da, AU - Lee,Kang-Yun, AU - Liu,Chien-Ying, AU - Yu,Chih-Teng, AU - Wang,Chun-Hua, AU - Kuo,Han-Pin, PY - 2011/9/2/entrez PY - 2011/9/2/pubmed PY - 2012/1/10/medline SP - 382 EP - 94 JF - Chang Gung medical journal JO - Chang Gung Med J VL - 34 IS - 4 N2 - BACKGROUND: A combination of salmeterol and fluticasone propionate (SAL/FP) has been shown to be effective in the treatment of asthma. We compared the efficacy and tolerability of SAL/FP (50/250 μg) with fluticasone propionate (FP) 250 μg administrated twice daily for 2 weeks in treating patients with mild to moderate asthma. METHODS: This was a randomized, double-blind study in adult patients with symptomatic asthma that was not controlled by 1000 μg/d inhaled corticosteroids (ICS) alone. 48 asthmatics were randomized to receive 2 inhalations of SAL/FP 50/250 μg bis in die (BID) or 2 inhalations of FP 250 μg BID, both delivered via Accuhaler device, for 2 weeks. The primary objective was the mean change from baseline in the mean morning peak expiratory flow (PEF) over the two week period. Other parameters included lung function, daily asthma symptom scores, evening PEF, percentage of days free of rescue medication use and daily rescue medication use. Tolerability was assessed by adverse events spontaneously elicited at clinic visits. RESULTS: 46 patients provided evaluable efficacy for analysis. The morning PEF improved significantly throughout the two weeks of treatment compared with baseline in the SAL/FP group. Mean morning PEF was 23.0 L/min higher in SAL/FP group than in FP group (p = 0.013). The change of forced expiratory volume in one second (FEV1) from baseline was greater in SAL/FP group compared to FP group (p = 0.048). There were similar effects on day-time and night-time symptom scores, percentage symptom free days and nights and usage of salbutamol. 70.8% of the patients receiving SAL/FP were satisfied with the treatment, while only 26.1% of patients receiving FP alone were (p = 0.020). No death or acute exacerbation occurred. CONCLUSION: SAL/FP 50/250 μg was safe and effective, and had a high level of patient satisfaction resulting in significantly greater increases in morning PEF and FEV1 compared to the use of FP 250 μg alone. SN - 2309-835X UR - https://www.unboundmedicine.com/medline/citation/21880193/Efficacy_and_tolerability_of_salmeterol/fluticasone_propionate_versus_fluticasone_propionate_in_asthma_patients:_a_randomized_double_blind_study_ L2 - http://cgmj.cgu.edu.tw/3404/340407.pdf DB - PRIME DP - Unbound Medicine ER -