STUDY OBJECTIVES: To examine and compare the efficacy and safety of salmeterol xinafoate, a long-acting inhaled beta2-adrenergic agonist, with inhaled ipratropium bromide and inhaled placebo in patients with COPD. DESIGN: A stratified, randomized, double-blind, double-dummy, placebo-controlled, parallel group clinical trial. SETTING: Multiple sites at clinics and university medical centers throughout the United States. PATIENTS: Four hundred eleven symptomatic patients with COPD with FEV1 <; or = 65% predicted and no clinically significant concurrent disease. INTERVENTIONS: Comparison of inhaled salmeterol (42 microg twice daily), inhaled ipratropium bromide (36 microg four times a day), and inhaled placebo (2 puffs four times a day) over 12 weeks. RESULTS:Salmeterol xinafoate was significantly (p < 0.0001) better than placebo and ipratropium in improving lung function at the recommended doses over the 12-week trial. Both salmeterol and ipratropium reduced dyspnea related to activities of daily living compared with placebo; this improvement was associated with reduced use of supplemental albuterol. Analyses of time to first COPD exacerbation revealed salmeterol to be superior to placebo and ipratropium (p < 0.05). Adverse effects were similar among the three treatments. CONCLUSIONS: These collective data support the use of salmeterol as first-line bronchodilator therapy for the long-term treatment of airflow obstruction in patients with COPD.
RCT Entities:
STUDY OBJECTIVES: To examine and compare the efficacy and safety of salmeterol xinafoate, a long-acting inhaled beta2-adrenergic agonist, with inhaled ipratropium bromide and inhaled placebo in patients with COPD. DESIGN: A stratified, randomized, double-blind, double-dummy, placebo-controlled, parallel group clinical trial. SETTING: Multiple sites at clinics and university medical centers throughout the United States. PATIENTS: Four hundred eleven symptomatic patients with COPD with FEV1 < or = 65% predicted and no clinically significant concurrent disease. INTERVENTIONS: Comparison of inhaled salmeterol (42 microg twice daily), inhaled ipratropium bromide (36 microg four times a day), and inhaled placebo (2 puffs four times a day) over 12 weeks. RESULTS:Salmeterol xinafoate was significantly (p < 0.0001) better than placebo and ipratropium in improving lung function at the recommended doses over the 12-week trial. Both salmeterol and ipratropium reduced dyspnea related to activities of daily living compared with placebo; this improvement was associated with reduced use of supplemental albuterol. Analyses of time to first COPD exacerbation revealed salmeterol to be superior to placebo and ipratropium (p < 0.05). Adverse effects were similar among the three treatments. CONCLUSIONS: These collective data support the use of salmeterol as first-line bronchodilator therapy for the long-term treatment of airflow obstruction in patients with COPD.
Authors: M Decramer; R Gosselink; P Bartsch; C-G Löfdahl; W Vincken; R Dekhuijzen; J Vestbo; R Pauwels; R Naeije; T Troosters Journal: Thorax Date: 2005-04 Impact factor: 9.139
Authors: Wendy C Moore; Eugene R Bleecker; Douglas Curran-Everett; Serpil C Erzurum; Bill T Ameredes; Leonard Bacharier; William J Calhoun; Mario Castro; Kian Fan Chung; Melissa P Clark; Raed A Dweik; Anne M Fitzpatrick; Benjamin Gaston; Mark Hew; Iftikhar Hussain; Nizar N Jarjour; Elliot Israel; Bruce D Levy; James R Murphy; Stephen P Peters; W Gerald Teague; Deborah A Meyers; William W Busse; Sally E Wenzel Journal: J Allergy Clin Immunol Date: 2007-02 Impact factor: 10.793
Authors: Dheeraj Gupta; Ritesh Agarwal; Ashutosh Nath Aggarwal; V N Maturu; Sahajal Dhooria; K T Prasad; Inderpaul S Sehgal; Lakshmikant B Yenge; Aditya Jindal; Navneet Singh; A G Ghoshal; G C Khilnani; J K Samaria; S N Gaur; D Behera Journal: Lung India Date: 2013-07