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A randomized, placebo-controlled study to evaluate the role of salmeterol in the in-hospital management of asthma.

Abstract

STUDY OBJECTIVES

To assess the safety and efficacy of salmeterol xinafoate as an adjunct to conventional therapy for the in-hospital management of acute asthma.

DESIGN

A prospective, double-blind, randomized placebo-controlled trial.

SETTING

Medical wards of a large university-based hospital.

PATIENTS

Forty-three patients admitted for an acute exacerbation of asthma.

INTERVENTIONS

Salmeterol (42 microg) or two puffs of placebo every 12 h in addition to standard therapy (short-acting beta-agonists, corticosteroids, and anticholinergic agents).

RESULTS

No clinically adverse effects were seen with the addition of salmeterol to conventional therapy. After salmeterol, there was no difference in pulse, respiratory rate, oxygen saturation by pulse oximetry, severity of symptoms, or dyspnea score. Patients receiving salmeterol had greater FEV(1) percent improvements than the placebo group at 12, 24, 36, and 48 h. These findings were not statistically significant. By paired Student's t tests, there were significant improvements in FEV(1) (p = 0.03) and FVC (p = 0.03) in the salmeterol group after 48 h of treatment with no comparable improvement in the placebo group. In a subgroup analysis of patients with an initial FEV(1) < or = 1.5 L, the absolute FEV(1) percent improvement for salmeterol vs placebo was 51% vs 16% at 24 h and 54% vs 40% at 48 h. The relative FEV(1) percent improvement for salmeterol vs placebo was 17% vs 8% at 24 h and 18% vs 14% at 48 h.

CONCLUSION

The addition of salmeterol to conventional therapy is safe and may benefit hospitalized patients with asthma. Further studies are needed to clarify its role in the treatment of acute exacerbation of asthma.

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  • Authors+Show Affiliations

    ,

    Department of Medicine, Division of Pulmonary Diseases/Critical Care Medicine, The University of Texas Health Science Center at San Antonio, USA. peters@uthscsa.edu

    , , , ,

    Source

    Chest 118:2 2000 Aug pg 313-20

    MeSH

    Acute Disease
    Administration, Inhalation
    Adolescent
    Adrenergic beta-Agonists
    Adult
    Aerosols
    Albuterol
    Asthma
    Cholinergic Antagonists
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Glucocorticoids
    Humans
    Inpatients
    Length of Stay
    Male
    Middle Aged
    Oximetry
    Prospective Studies
    Respiratory Function Tests
    Safety
    Salmeterol Xinafoate
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    10936118

    Citation

    Peters, J I., et al. "A Randomized, Placebo-controlled Study to Evaluate the Role of Salmeterol in the In-hospital Management of Asthma." Chest, vol. 118, no. 2, 2000, pp. 313-20.
    Peters JI, Shelledy DC, Jones AP, et al. A randomized, placebo-controlled study to evaluate the role of salmeterol in the in-hospital management of asthma. Chest. 2000;118(2):313-20.
    Peters, J. I., Shelledy, D. C., Jones, A. P., Lawson, R. W., Davis, C. P., & LeGrand, T. S. (2000). A randomized, placebo-controlled study to evaluate the role of salmeterol in the in-hospital management of asthma. Chest, 118(2), pp. 313-20.
    Peters JI, et al. A Randomized, Placebo-controlled Study to Evaluate the Role of Salmeterol in the In-hospital Management of Asthma. Chest. 2000;118(2):313-20. PubMed PMID: 10936118.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A randomized, placebo-controlled study to evaluate the role of salmeterol in the in-hospital management of asthma. AU - Peters,J I, AU - Shelledy,D C, AU - Jones,A P,Jr AU - Lawson,R W, AU - Davis,C P, AU - LeGrand,T S, PY - 2000/8/11/pubmed PY - 2000/9/9/medline PY - 2000/8/11/entrez SP - 313 EP - 20 JF - Chest JO - Chest VL - 118 IS - 2 N2 - STUDY OBJECTIVES: To assess the safety and efficacy of salmeterol xinafoate as an adjunct to conventional therapy for the in-hospital management of acute asthma. DESIGN: A prospective, double-blind, randomized placebo-controlled trial. SETTING: Medical wards of a large university-based hospital. PATIENTS: Forty-three patients admitted for an acute exacerbation of asthma. INTERVENTIONS: Salmeterol (42 microg) or two puffs of placebo every 12 h in addition to standard therapy (short-acting beta-agonists, corticosteroids, and anticholinergic agents). RESULTS: No clinically adverse effects were seen with the addition of salmeterol to conventional therapy. After salmeterol, there was no difference in pulse, respiratory rate, oxygen saturation by pulse oximetry, severity of symptoms, or dyspnea score. Patients receiving salmeterol had greater FEV(1) percent improvements than the placebo group at 12, 24, 36, and 48 h. These findings were not statistically significant. By paired Student's t tests, there were significant improvements in FEV(1) (p = 0.03) and FVC (p = 0.03) in the salmeterol group after 48 h of treatment with no comparable improvement in the placebo group. In a subgroup analysis of patients with an initial FEV(1) < or = 1.5 L, the absolute FEV(1) percent improvement for salmeterol vs placebo was 51% vs 16% at 24 h and 54% vs 40% at 48 h. The relative FEV(1) percent improvement for salmeterol vs placebo was 17% vs 8% at 24 h and 18% vs 14% at 48 h. CONCLUSION: The addition of salmeterol to conventional therapy is safe and may benefit hospitalized patients with asthma. Further studies are needed to clarify its role in the treatment of acute exacerbation of asthma. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/10936118/A_randomized_placebo_controlled_study_to_evaluate_the_role_of_salmeterol_in_the_in_hospital_management_of_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)51785-6 DB - PRIME DP - Unbound Medicine ER -