Document Detail

Inhaled salmeterol in the treatment of patients with moderate to severe reversible obstructive airways disease--a 3-month comparison of the efficacy and safety of twice-daily salmeterol (100 micrograms) with salmeterol (50 micrograms).
MedLine Citation:
PMID:  1361068     Owner:  NLM     Status:  MEDLINE    
Three-hundred and fifty patients with moderate to severe reversible obstructive airways disease (forced expiratory volume in 1 s or peak expiratory flow rate < or = 50% predicted, a 15% reversibility to inhaled salbutamol and symptomatic) were recruited into a multi-centre, multinational, double-blind, parallel-group randomized study. Two-hundred and eighty-three patients were randomized to receive 50 micrograms salmeterol twice daily or 100 micrograms salmeterol twice daily administered from a metered-dose inhaler for 3 months. Salbutamol (100 micrograms per metered actuation) was provided for symptomatic relief. Morning and evening peak expiratory flow rate (PEFR), day-time and night-time asthma symptoms and additional bronchodilator usage were recorded by the patient on a daily basis. Lung function and patient/physician assessment of treatment efficacy were recorded at scheduled clinic visits. Safety was determined by monitoring adverse events and standard biochemical, haematological and cardiovascular parameters. Salmeterol 100 micrograms twice daily was consistently superior to salmeterol 50 micrograms twice daily in morning and evening PEFR measurements (mean differences between the treatments: 10-14 l min-1 for morning, 95% CI-0, 22 l min-1, P = 0.047; and 10-15 l min-1 for evening, 95% CI 2, 22 l min-1, P = 0.023). The improvement in PEFR was independent of concurrent steroid usage, with the most marked improvement being seen in the more severe asthmatics requiring concurrent oral corticosteroids (mean differences between the treatments: 27-31 l min-1, 95% CI: 3,55 l m-1, P = 0.027).(ABSTRACT TRUNCATED AT 250 WORDS)
J B Palmer; A M Stuart; G L Shepherd; K Viskum
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Respiratory medicine     Volume:  86     ISSN:  0954-6111     ISO Abbreviation:  Respir Med     Publication Date:  1992 Sep 
Date Detail:
Created Date:  1993-01-08     Completed Date:  1993-01-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8908438     Medline TA:  Respir Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  409-17     Citation Subset:  IM    
Clinical Research, Glaxo Inc., Research Triangle Park, North Carolina.
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MeSH Terms
Administration, Inhalation
Adrenergic beta-Antagonists / administration & dosage*,  adverse effects
Aged, 80 and over
Albuterol / administration & dosage,  adverse effects,  analogs & derivatives*
Double-Blind Method
Drug Administration Schedule
Lung Diseases, Obstructive / drug therapy*
Middle Aged
Reg. No./Substance:
0/Adrenergic beta-Antagonists; 18559-94-9/Albuterol; 89365-50-4/salmeterol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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