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Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma.
J Asthma. 2004; 41(8):797-806.JA

Abstract

The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP) (44 microg)/salmeterol (21 microg) delivered as two inhalations twice daily via a single hydrofluoroalkane (HFA 134a) metered dose inhaler (MDI) (FSC) with that of placebo HFA 134a (PLA), fluticasone propionate 44 microg chlorofluorocarbon (CFC) alone and salmeterol 21 microg CFC alone (S) in patients (n=360) with persistent asthma previously treated with beta2-agonists (short- or long-acting) or inhaled corticosteroids (ICS). After 12 weeks of treatment, patients treated with FSC had a significantly greater increase (p < or = 0.006) in mean FEV1 AUC(bl) compared with PLA, FP, or S. At end point, mean change from baseline in morning predose FEV1 for FSC (0.58 L) was significantly (p < or = 0.004) greater than PLA (0.14 L), FP (0.36 L), and S (0.25 L). Patients treated with FSC also had a significantly higher probability of remaining in the study without being withdrawn due to worsening asthma (2%) compared with those in the PLA (29%) and S (25%) groups (p < 0.001). Finally, treatment with FSC resulted in significantly (p < or = 0.007) greater improvements in morning and evening peak expiratory flow, need for rescue albuterol, and asthma symptom scores compared with FP, S, and PLA. The safety profile of FSC was also similar to FP or S alone. Initial maintenance treatment of the two main components of asthma, inflammation, and smooth muscle dysfunction (e.g., bronchoconstriction), with FSC results in greater overall improvements in asthma control compared with treatment of either individual component alone.

Authors+Show Affiliations

Colorado Allergy and Asthma Centers, P.C., Denver, Colorado 80230, USA. ds.pearlman@coloradoallergy.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15641629

Citation

Pearlman, David S., et al. "Efficacy and Safety of Fluticasone Propionate/salmeterol HFA 134A MDI in Patients With Mild-to-moderate Persistent Asthma." The Journal of Asthma : Official Journal of the Association for the Care of Asthma, vol. 41, no. 8, 2004, pp. 797-806.
Pearlman DS, Peden D, Condemi JJ, et al. Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma. J Asthma. 2004;41(8):797-806.
Pearlman, D. S., Peden, D., Condemi, J. J., Weinstein, S., White, M., Baitinger, L., Scott, C., Ho, S. Y., House, K., & Dorinsky, P. (2004). Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma. The Journal of Asthma : Official Journal of the Association for the Care of Asthma, 41(8), 797-806.
Pearlman DS, et al. Efficacy and Safety of Fluticasone Propionate/salmeterol HFA 134A MDI in Patients With Mild-to-moderate Persistent Asthma. J Asthma. 2004;41(8):797-806. PubMed PMID: 15641629.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma. AU - Pearlman,David S, AU - Peden,David, AU - Condemi,John J, AU - Weinstein,Steven, AU - White,Martha, AU - Baitinger,Leslie, AU - Scott,Catherine, AU - Ho,Shu-Yen, AU - House,Karen, AU - Dorinsky,Paul, PY - 2005/1/12/pubmed PY - 2005/1/29/medline PY - 2005/1/12/entrez SP - 797 EP - 806 JF - The Journal of asthma : official journal of the Association for the Care of Asthma JO - J Asthma VL - 41 IS - 8 N2 - The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP) (44 microg)/salmeterol (21 microg) delivered as two inhalations twice daily via a single hydrofluoroalkane (HFA 134a) metered dose inhaler (MDI) (FSC) with that of placebo HFA 134a (PLA), fluticasone propionate 44 microg chlorofluorocarbon (CFC) alone and salmeterol 21 microg CFC alone (S) in patients (n=360) with persistent asthma previously treated with beta2-agonists (short- or long-acting) or inhaled corticosteroids (ICS). After 12 weeks of treatment, patients treated with FSC had a significantly greater increase (p < or = 0.006) in mean FEV1 AUC(bl) compared with PLA, FP, or S. At end point, mean change from baseline in morning predose FEV1 for FSC (0.58 L) was significantly (p < or = 0.004) greater than PLA (0.14 L), FP (0.36 L), and S (0.25 L). Patients treated with FSC also had a significantly higher probability of remaining in the study without being withdrawn due to worsening asthma (2%) compared with those in the PLA (29%) and S (25%) groups (p < 0.001). Finally, treatment with FSC resulted in significantly (p < or = 0.007) greater improvements in morning and evening peak expiratory flow, need for rescue albuterol, and asthma symptom scores compared with FP, S, and PLA. The safety profile of FSC was also similar to FP or S alone. Initial maintenance treatment of the two main components of asthma, inflammation, and smooth muscle dysfunction (e.g., bronchoconstriction), with FSC results in greater overall improvements in asthma control compared with treatment of either individual component alone. SN - 0277-0903 UR - https://www.unboundmedicine.com/medline/citation/15641629/Efficacy_and_safety_of_fluticasone_propionate/salmeterol_HFA_134A_MDI_in_patients_with_mild_to_moderate_persistent_asthma_ L2 - https://www.tandfonline.com/doi/full/10.1081/jas-200038368 DB - PRIME DP - Unbound Medicine ER -