A twelve-week comparison of salmeterol and salbutamol in the treatment of mild-to-moderate asthma: a Canadian multicenter study

J Allergy Clin Immunol. 1997 Jan;99(1 Pt 1):13-21. doi: 10.1016/s0091-6749(97)70295-1.


Background: A long-acting inhaled bronchodilator that is both well tolerated and effective could allow for improved control of both daytime and nighttime symptoms in patients with asthma who use frequent as-needed short-acting bronchodilators despite antiinflammatory treatment.

Objective and methods: We compared the efficacy and safety of inhaled salmeterol, 50 micrograms twice daily, with inhaled salbutamol, 200 micrograms four times daily, delivered through a metered-dose inhaler for 3 months in a multicenter, randomized, double-blind, parallel-group study of 228 patients (aged 12 to 76 years) with mild-to-moderate asthma.

Results: A single morning dose of salmeterol produced improvement in FEV1 that was significantly greater (p < or = 0.012) than that produced by two doses of salbutamol (taken 6 hours apart) when patients were assessed 3 to 6 hours and 10 to 12 hours after the dose. This greater bronchodilation was present on day 1 of the study and after 4, 8, and 12 weeks of regular treatment. Over the 12 weeks, compared with salbutamol, salmeterol treatment was associated with a greater mean improvement in morning peak expiratory flow (35 L/min vs -3 L/min, p < 0.001), a higher percentage of days with no symptoms (29% vs 15%; p = 0.012), and a higher percentage of nights with no awakenings (14% vs -1%; p < 0.001). Adverse events were similar for both treatments.

Conclusions: In this study salmeterol, 50 micrograms twice daily, was well tolerated and more effective than salbutamol, 200 micrograms four times daily, in improving symptoms and lung function in patients with mild-to-moderate asthma.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-Agonists / adverse effects
  • Adrenergic beta-Agonists / therapeutic use*
  • Adult
  • Albuterol / adverse effects
  • Albuterol / analogs & derivatives*
  • Albuterol / therapeutic use*
  • Asthma / drug therapy*
  • Bronchodilator Agents / adverse effects
  • Bronchodilator Agents / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Electrocardiography
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Middle Aged
  • Respiratory Function Tests
  • Salmeterol Xinafoate


  • Adrenergic beta-Agonists
  • Bronchodilator Agents
  • Salmeterol Xinafoate
  • Albuterol