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Fluticasone propionate and salmeterol administered via Diskus compared with salmeterol or fluticasone propionate alone in patients suboptimally controlled with short-acting beta2-agonists.

Abstract

BACKGROUND

Optimal therapy for many patients with persistent asthma requires control of both main components of this disease: inflammation and bronchoconstriction.

OBJECTIVES

To compare the efficacy and safety of initiating maintenance therapy with an inhaled, long-acting beta2-agonist and an inhaled corticosteroid administered from a single device with that of the individual agents alone.

METHODS

A 12-week, randomized, double-blind study was conducted in patients 12 years and older with persistent asthma who were symptomatic while taking as-needed, short-acting beta2-agonists alone. Treatments were administered twice daily via the Diskus device: salmeterol, 50 microg; fluticasone propionate, 100 microg; or fluticasone propionate, 100 microg, with salmeterol, 50 microg.

RESULTS

Of 555 patients screened, 267 were randomly assigned to treatment. At end point, fluticasone propionate and salmeterol significantly increased predose forced expiratory volume in 1 second (FEV1) compared with salmeterol alone (0.51 +/- 0.05 L vs 0.38 +/- 0.04 L, P = .04). Fluticasone propionate and salmeterol significantly increased area under the serial FEV1 curve at treatment week 12 relative to predose FEV1 (baseline) on treatment day 1 (AUCb1, 8.4 +/- 0.6 L/h; P < or = .02) compared with salmeterol (6.2 +/- 0.5 L/h) and fluticasone propionate (7.0 +/- 0.6 L/h). Fluticasone propionate and salmeterol were significantly (P < or = .02) more effective than the individual agents used alone in improving morning and evening peak expiratory flow rate and asthma symptoms. In addition, fluticasone propionate and salmeterol effectively reduced rescue albuterol use (P < or = .04). All treatments were well tolerated.

CONCLUSIONS

In patients symptomatic while taking short-acting beta2-agonists alone, initial maintenance treatment of the 2 main components of asthma, inflammation and smooth muscle dysfunction, with fluticasone propionate and salmeterol, 100 and 50 microg, administered via the Diskus results in greater improvements in overall asthma control compared with treatment of either component alone.

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  • Authors+Show Affiliations

    ,

    Vanderbilt Asthma, Sinus and Allergy Program, Nashville, Tennessee 37203, USA. john.murray@vanderbilt.edu

    , , , , , ,

    Source

    MeSH

    Administration, Inhalation
    Adolescent
    Adrenergic beta-Agonists
    Adult
    Aged
    Albuterol
    Androstadienes
    Asthma
    Bronchodilator Agents
    Child
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Fluticasone
    Humans
    Male
    Middle Aged
    Nebulizers and Vaporizers
    Salmeterol Xinafoate
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    15521371

    Citation

    Murray, John, et al. "Fluticasone Propionate and Salmeterol Administered Via Diskus Compared With Salmeterol or Fluticasone Propionate Alone in Patients Suboptimally Controlled With Short-acting Beta2-agonists." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 93, no. 4, 2004, pp. 351-9.
    Murray J, Rosenthal R, Somerville L, et al. Fluticasone propionate and salmeterol administered via Diskus compared with salmeterol or fluticasone propionate alone in patients suboptimally controlled with short-acting beta2-agonists. Ann Allergy Asthma Immunol. 2004;93(4):351-9.
    Murray, J., Rosenthal, R., Somerville, L., Blake, K., House, K., Baitinger, L., ... Dorinsky, P. (2004). Fluticasone propionate and salmeterol administered via Diskus compared with salmeterol or fluticasone propionate alone in patients suboptimally controlled with short-acting beta2-agonists. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 93(4), pp. 351-9.
    Murray J, et al. Fluticasone Propionate and Salmeterol Administered Via Diskus Compared With Salmeterol or Fluticasone Propionate Alone in Patients Suboptimally Controlled With Short-acting Beta2-agonists. Ann Allergy Asthma Immunol. 2004;93(4):351-9. PubMed PMID: 15521371.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Fluticasone propionate and salmeterol administered via Diskus compared with salmeterol or fluticasone propionate alone in patients suboptimally controlled with short-acting beta2-agonists. AU - Murray,John, AU - Rosenthal,Richard, AU - Somerville,Laura, AU - Blake,Kathryn, AU - House,Karen, AU - Baitinger,Leslie, AU - VanderMeer,Anna, AU - Dorinsky,Paul, PY - 2004/11/4/pubmed PY - 2004/12/16/medline PY - 2004/11/4/entrez SP - 351 EP - 9 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 93 IS - 4 N2 - BACKGROUND: Optimal therapy for many patients with persistent asthma requires control of both main components of this disease: inflammation and bronchoconstriction. OBJECTIVES: To compare the efficacy and safety of initiating maintenance therapy with an inhaled, long-acting beta2-agonist and an inhaled corticosteroid administered from a single device with that of the individual agents alone. METHODS: A 12-week, randomized, double-blind study was conducted in patients 12 years and older with persistent asthma who were symptomatic while taking as-needed, short-acting beta2-agonists alone. Treatments were administered twice daily via the Diskus device: salmeterol, 50 microg; fluticasone propionate, 100 microg; or fluticasone propionate, 100 microg, with salmeterol, 50 microg. RESULTS: Of 555 patients screened, 267 were randomly assigned to treatment. At end point, fluticasone propionate and salmeterol significantly increased predose forced expiratory volume in 1 second (FEV1) compared with salmeterol alone (0.51 +/- 0.05 L vs 0.38 +/- 0.04 L, P = .04). Fluticasone propionate and salmeterol significantly increased area under the serial FEV1 curve at treatment week 12 relative to predose FEV1 (baseline) on treatment day 1 (AUCb1, 8.4 +/- 0.6 L/h; P < or = .02) compared with salmeterol (6.2 +/- 0.5 L/h) and fluticasone propionate (7.0 +/- 0.6 L/h). Fluticasone propionate and salmeterol were significantly (P < or = .02) more effective than the individual agents used alone in improving morning and evening peak expiratory flow rate and asthma symptoms. In addition, fluticasone propionate and salmeterol effectively reduced rescue albuterol use (P < or = .04). All treatments were well tolerated. CONCLUSIONS: In patients symptomatic while taking short-acting beta2-agonists alone, initial maintenance treatment of the 2 main components of asthma, inflammation and smooth muscle dysfunction, with fluticasone propionate and salmeterol, 100 and 50 microg, administered via the Diskus results in greater improvements in overall asthma control compared with treatment of either component alone. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/15521371/Fluticasone_propionate_and_salmeterol_administered_via_Diskus_compared_with_salmeterol_or_fluticasone_propionate_alone_in_patients_suboptimally_controlled_with_short_acting_beta2_agonists_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)61394-4 DB - PRIME DP - Unbound Medicine ER -