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Low-dose fluticasone propionate with and without salmeterol in steroid-naïve patients with mild, uncontrolled asthma.
Respir Med. 2010 Apr; 104(4):510-7.RM

Abstract

BACKGROUND

The role of combination ICS/LABA as initial controller therapy in mild, persistent asthma is uncertain. Therefore, the objective of this study was to compare the efficacy of initial controller therapy with fluticasone propionate (FP) 100 microg twice daily to the efficacy of fluticasone propionate/salmeterol xinafoate (FSC) 100/50 microg twice daily in patients with persistent asthma symptoms while using as-needed SABA alone.

METHODS

This randomized, double-blind, parallel-group study was conducted at 45 general practice and 15 specialist centers. A total of 526 adult patients were randomized to receive FP or FSC for 24 weeks. The primary efficacy endpoint was change in morning peak expiratory flow (PEF) from baseline. Secondary efficacy endpoints included symptom- and rescue-free days; asthma exacerbation rate; asthma-related health-care utilization; and the onset of effect. Safety was assessed by monitoring adverse events.

RESULTS

Mean morning PEF was significantly greater in the FSC versus the FP group (P<0.001); this greater effect was evident as early as the first week of treatment (P<0.001). The percentages of symptom-free days and rescue-free days in the FSC group were 7.7% (P=0.009) and 8.4% (P=0.001) higher than the FP group, respectively. Trends toward lower exacerbation-related health care-utilization for FSC versus FP were not statistically significant and exacerbation rates were not significantly different. The incidence of adverse events was low with both treatments.

CONCLUSIONS

:Treatment with FSC was a more effective initial controller therapy than FP monotherapy in ICS-naïve patients who had uncontrolled asthma while using as-needed SABA alone.

Authors+Show Affiliations

University of Montreal, Montreal, Quebec, Canada. renzip@earthlink.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19944581

Citation

Renzi, Paolo M., et al. "Low-dose Fluticasone Propionate With and Without Salmeterol in Steroid-naïve Patients With Mild, Uncontrolled Asthma." Respiratory Medicine, vol. 104, no. 4, 2010, pp. 510-7.
Renzi PM, Howard LA, Ortega HG, et al. Low-dose fluticasone propionate with and without salmeterol in steroid-naïve patients with mild, uncontrolled asthma. Respir Med. 2010;104(4):510-7.
Renzi, P. M., Howard, L. A., Ortega, H. G., Ahmad, F. F., & Chapman, K. R. (2010). Low-dose fluticasone propionate with and without salmeterol in steroid-naïve patients with mild, uncontrolled asthma. Respiratory Medicine, 104(4), 510-7. https://doi.org/10.1016/j.rmed.2009.10.025
Renzi PM, et al. Low-dose Fluticasone Propionate With and Without Salmeterol in Steroid-naïve Patients With Mild, Uncontrolled Asthma. Respir Med. 2010;104(4):510-7. PubMed PMID: 19944581.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose fluticasone propionate with and without salmeterol in steroid-naïve patients with mild, uncontrolled asthma. AU - Renzi,Paolo M, AU - Howard,Lisa A, AU - Ortega,Hector G, AU - Ahmad,Faiz F, AU - Chapman,Kenneth R, Y1 - 2009/11/26/ PY - 2009/06/16/received PY - 2009/10/29/revised PY - 2009/10/29/accepted PY - 2009/12/1/entrez PY - 2009/12/1/pubmed PY - 2010/10/1/medline SP - 510 EP - 7 JF - Respiratory medicine JO - Respir Med VL - 104 IS - 4 N2 - BACKGROUND: The role of combination ICS/LABA as initial controller therapy in mild, persistent asthma is uncertain. Therefore, the objective of this study was to compare the efficacy of initial controller therapy with fluticasone propionate (FP) 100 microg twice daily to the efficacy of fluticasone propionate/salmeterol xinafoate (FSC) 100/50 microg twice daily in patients with persistent asthma symptoms while using as-needed SABA alone. METHODS: This randomized, double-blind, parallel-group study was conducted at 45 general practice and 15 specialist centers. A total of 526 adult patients were randomized to receive FP or FSC for 24 weeks. The primary efficacy endpoint was change in morning peak expiratory flow (PEF) from baseline. Secondary efficacy endpoints included symptom- and rescue-free days; asthma exacerbation rate; asthma-related health-care utilization; and the onset of effect. Safety was assessed by monitoring adverse events. RESULTS: Mean morning PEF was significantly greater in the FSC versus the FP group (P<0.001); this greater effect was evident as early as the first week of treatment (P<0.001). The percentages of symptom-free days and rescue-free days in the FSC group were 7.7% (P=0.009) and 8.4% (P=0.001) higher than the FP group, respectively. Trends toward lower exacerbation-related health care-utilization for FSC versus FP were not statistically significant and exacerbation rates were not significantly different. The incidence of adverse events was low with both treatments. CONCLUSIONS: :Treatment with FSC was a more effective initial controller therapy than FP monotherapy in ICS-naïve patients who had uncontrolled asthma while using as-needed SABA alone. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/19944581/Low_dose_fluticasone_propionate_with_and_without_salmeterol_in_steroid_naïve_patients_with_mild_uncontrolled_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(09)00360-6 DB - PRIME DP - Unbound Medicine ER -