The effect of salmeterol on nocturnal symptoms, airway function, and inflammation in asthma.
OBJECTIVE
To determine the efficacy of salmeterol alone in a group of patients with moderate asthma with nocturnal worsening of symptoms.


METHODS
Double-blind, randomized, placebo-controlled crossover study.


METHODS
Tertiary care hospital specializing in respiratory diseases.


METHODS
Ten patients with nocturnal asthma.


METHODS
Subjects were randomized to salmeterol, 100 micrograms twice daily, or placebo for 6 weeks with a 1-week washout between treatment periods. Symptoms, nocturnal awakenings, and beta 2-agonist use were recorded daily. Spirometry was performed at weeks 1 and 6 of each period at bedtime and at 4 AM, and methacholine challenge was performed at 4 AM followed by bronchoscopy with BAL. BAL fluid analysis included cell count and differential count, eosinophil cationic protein, Charcot-Leyden crystal protein, leukotriene B4, and thromboxane B2.


RESULTS
The percentage of nights with awakenings decreased significantly with salmeterol (69.8 +/- 8.7% vs 30.6 +/- 10.8% for placebo and salmeterol, respectively; p = 0.02). The percentage of 24-h days with supplemental inhaled beta 2-agonist use significantly decreased with salmeterol (85.9 +/- 9.4% vs 70.4 +/- 10.1% for placebo and salmeterol, respectively; p = 0.04). There were no significant differences in bronchial reactivity, 4 AM FEV1, overnight percentage change in FEV1, or indexes of airway inflammation.


CONCLUSIONS
Salmeterol alone improves the number of nocturnal awakenings and supplemental 24-h beta 2-agonist use in nocturnal asthma without significantly altering lung function and airway inflammation.
Kraft
M
M
Department of Medicine, National Jewish Center for Immunology and Respiratory Medicine, Denver, CO 80206, USA.
Wenzel
S E
SE
Bettinger
C M
CM
Martin
R J
RJ
D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001798:Blood Proteins / Q000032:analysis; D001992:Bronchoalveolar Lavage Fluid / Q000737:chemistry / Q000166:cytology; D016085:Bronchoconstrictor Agents; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001999:Bronchoscopy; D002452:Cell Count; D002940:Circadian Rhythm; D018592:Cross-Over Studies; D004311:Double-Blind Method; D047091:Eosinophil Granule Proteins; D004804:Eosinophils / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects; D006023:Glycoproteins / Q000032:analysis; D006801:Humans; D007249:Inflammation; D018836:Inflammation Mediators / Q000032:analysis; D007975:Leukotriene B4 / Q000032:analysis; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008245:Lysophospholipase / Q000032:analysis; D008297:Male; D016210:Methacholine Chloride; D010919:Placebos; D012260:Ribonucleases; D000068299:Salmeterol Xinafoate; D012890:Sleep / Q000187:drug effects; D013147:Spirometry; D013929:Thromboxane B2 / Q000032:analysis
D000318:Adrenergic beta-Agonists; D001798:Blood Proteins; D016085:Bronchoconstrictor Agents; D001993:Bronchodilator Agents; D047091:Eosinophil Granule Proteins; D006023:Glycoproteins; D018836:Inflammation Mediators; D010919:Placebos; D016210:Methacholine Chloride; D007975:Leukotriene B4; D013929:Thromboxane B2; D000068299:Salmeterol Xinafoate; D012260:Ribonucleases; D008245:Lysophospholipase; C011711:lysolecithin acylhydrolase; D000420:Albuterol