Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: A 12-week study

• Published in: Respiratory medicine Vol. 105; no. 5; pp. 719 - 726
• Main Authors: Korn, Stephanie, Kerwin, Edward, Atis, Sibel, Amos, Carolynn, Owen, Roger, Lassen, Cheryl
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.05.2011; Elsevier; Elsevier Limited
• Subjects: Albuterol - administration & dosage; Albuterol - analogs & derivatives; beta2-agonist; Biological and medical sciences; Bronchodilator; Bronchodilator Agents - administration & dosage; Chronic obstructive pulmonary disease, asthma; Confidence intervals; COPD; Diabetes; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug therapy; Female; Forced Expiratory Volume - drug effects; Forced Expiratory Volume - physiology; Humans; Indacaterol; Indans - administration & dosage; Male; Medical sciences; Middle Aged; Pharmaceutical industry; Pneumology; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Pulmonary/Respiratory; Quinolones - administration & dosage; Respiratory Function Tests - methods; Salmeterol; Salmeterol Xinafoate; Treatment Outcome; Germany; Indacaterol; Bronchodilator; Salmeterol; beta2-agonist; COPD; Lung disease; Agonist; Respiratory disease; Chronic; Daily; Efficiency; Bronchus disease; Chronic obstructive pulmonary disease; Obstructive pulmonary disease; Pneumology
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2011.02.008

Summary Background Indacaterol is a novel, inhaled once-daily ultra-long-acting β2 -agonist for the treatment of COPD. Methods This 12-week randomised, parallel-group study compared the efficacy of indacaterol 150 μg once-daily to salmeterol 50 μg twice-daily in patients with moderate-to-severe COPD. Assessments included FEV1 standardised area under curve (AUC) from 5 min to 11 h 45 min at Week 12 (primary endpoint), 24-h trough FEV1 (mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (key secondary endpoint), FEV1 and FVC measured over 24-h, transition dyspnoea index (TDI) and rescue medication use. Results Of 1123 patients randomised 92.1% completed. Mean ± SD age was 62.8 ± 8.78 years, post-bronchodilator FEV1 51.8 ± 12.32% predicted, FEV1 /FVC 50.6 ± 9.54%. At Week 12, FEV1 AUC5 min–11 h 45 min for indacaterol was statistically superior ( p  < 0.001) to salmeterol (adjusted mean difference [95% CI] 57 [35, 79] mL), as was 24-h trough FEV1 (60 [37, 83] mL, p  < 0.001). Indacaterol also showed statistical superiority over salmeterol in terms of FEV1 and FVC measured over 24-h at Week 12. For TDI at Week 12, the mean total score was statistically superior for indacaterol versus salmeterol (difference 0.63 [0.30, 0.97], p  < 0.001), as was the percentage of patients with a clinically relevant (i.e., ≥1 point) change from baseline (69.4% vs 62.7%, p  < 0.05). For rescue medication, patients on indacaterol used fewer puffs/day (difference −0.18 [–0.36, 0.00] puffs/day, p  < 0.05) and had a greater percentage of days with no rescue use (difference 4.4 [0.6, 8.2], p  < 0.05). Conclusion Once-daily indacaterol provided statistically superior bronchodilation with an improvement in breathlessness and rescue use compared with twice-daily salmeterol. ClinicalTrials.gov NCT00821093