Effectiveness and tolerability of high-dose salmeterol in cystic fibrosis

Pediatr Pulmonol. 2002 Oct;34(4):287-96. doi: 10.1002/ppul.10162.


The efficacy and tolerability of high-dose salmeterol (100 mcg, BID) and albuterol (2.5 mg, BID) were compared with those of albuterol (2.5 mg, BID) in outpatients with cystic fibrosis in a randomized, double-blind, double-dummy, placebo-controlled, crossover study with both short- (4 weeks of each) and long-term (24 weeks of each) treatment periods. The primary outcome measure was the difference in mean change in forced expired volume in 1 sec (FEV(1)) from baseline to the end of each treatment, and secondary measures included changes in forced vital capacity (FVC), forced expiratory flow between 25-75% of FVC (FEF(25-75)), patient-rated weekly symptom scores, number of extra (rescue) albuterol treatments, and number of antibiotic treatments. Tolerability was evaluated by changes in vital signs and adverse events.Thirty-six out of 44 patients enrolled finished the short-term treatment period, and 19 out of 23 who continued the study also finished the long-term treatment period. There was no significant difference in the mean % change in FEV(1) from baseline to completion of 4 weeks with each drug in the short-term treatment period (0.1% vs. 0.06%, albuterol vs. salmeterol; respectively). In the long-term treatment period, there was a significant decrease from baseline in FEV(1) with albuterol vs. salmeterol, as measured after both 12 and 24 weeks of each treatment (-6.2% vs. 1.8%, P = 0.013 after 12 weeks, and -6.5% vs. 1.7%, P = 0.002, after 24 weeks, respectively). In both treatment periods, salmeterol was well-tolerated. While there were more rescue treatments per patient per week with albuterol than with salmeterol treatment in both the short- and long-term periods (0.67 vs. 0.40 and 1.76 vs. 0.74, respectively), rescue treatments were needed significantly more often for only the long-term period with albuterol compared to salmeterol (P = 0.022). Also, there were more antibiotic interventions with albuterol than with salmeterol treatment in both the short- and long-term periods (25 vs. 10 and 56 vs. 42, respectively); however, antibiotics were needed significantly more often for only the short-term period (P = 0.011). In addition, there was a significantly higher symptom score with albuterol vs. salmeterol treatment during the second half of the long-term period (1.24 vs. 0.89, P = 0.001).In conclusion, long-term high-dose salmeterol was equally safe and was associated with better pulmonary function, fewer interventions, and fewer respiratory symptoms compared to standard therapy with albuterol in a population of outpatients with mild to moderate CF.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Albuterol / administration & dosage*
  • Albuterol / analogs & derivatives*
  • Anti-Bacterial Agents / therapeutic use
  • Blood Pressure / drug effects
  • Blood Pressure / physiology
  • Bronchodilator Agents / administration & dosage*
  • Cross-Over Studies
  • Cystic Fibrosis / drug therapy*
  • Cystic Fibrosis / physiopathology
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume / drug effects
  • Forced Expiratory Volume / physiology
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Pulse
  • Reference Values
  • Salmeterol Xinafoate
  • Spirometry
  • Time Factors
  • Vital Capacity / drug effects
  • Vital Capacity / physiology


  • Anti-Bacterial Agents
  • Bronchodilator Agents
  • Salmeterol Xinafoate
  • Albuterol