title: Randomised trial comparing as-needed versus regular treatment with formoterol in patients with persistent asthma.
abstract: OBJECTIVE
  The aim of this study was to demonstrate the equivalent efficacy of inhaled formoterol in asthmatic patients, either given as-needed or on a regular twice-daily schedule.
  
  
  METHODS
  Randomised, open 12-week study in patients with mild to moderate asthma not adequately controlled with inhaled glucocorticosteroids alone. Patients received inhaled formoterol as needed or on a regular schedule (2x2 puffs/day with 6 microg formoterol per puff). Patients in the twice-daily formoterol group could use salbutamol as a rescue medication. The primary endpoint was the number of patients with asthma exacerbations in each group.
  
  
  RESULTS
  Thirty-nine centres randomised 359 patients. The number of patients with asthma exacerbations showed neither a clinically relevant nor a statistically significant difference between groups: formoterol as-needed: 3.95% (7 of 177); twice daily: 3.45% (6 of 174). Patients in the formoterol as-needed group used significantly less formoterol (-1.5 puffs per day; P<0.0001). Including the saved rescue medication (up to one puff per day), total beta-2 agonist use in the formoterol as-needed group decreased by approximately 2-2.5 puffs per day. Both formoterol treatment schedules were well tolerated. Musculoskeletal pain and tremor were less frequent in the formoterol as-needed group: headaches were slightly more frequent.
  
  
  CONCLUSIONS
  Formoterol given as needed and without additional beta-2 agonist, and formoterol given on a regular basis twice daily, supplemented by salbutamol as a rescue medication, appeared equally effective in this clinical study. Drug consumption was markedly lower in the former group.
authors.affiliation: Pulmonary Research Institute at Hospital Grosshansdorf, Center for Pneumology and Thoracic Surgery, Woehrendamm 80, 22927 Grosshansdorf, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Richter
authors.forename: U
authors.initials: U
authors.lastname: Hartmann
authors.forename: P
authors.initials: P
authors.lastname: Metzenauer
authors.forename: H
authors.initials: H
authors.lastname: Magnussen
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D010349:Patient Compliance; D013147:Spirometry / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D000420:Albuterol; D000068759:Formoterol Fumarate