K Richter1, U Hartmann, P Metzenauer, H Magnussen. 1. Pulmonary Research Institute at Hospital Grosshansdorf, Center for Pneumology and Thoracic Surgery, Woehrendamm 80, 22927 Grosshansdorf, Germany.
Abstract
PURPOSE: 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. CONCLUSION: 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.
RCT Entities:
PURPOSE: 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. CONCLUSION: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.