Sustained 24-hour efficacy of once daily indacaterol (300 μg) in patients with chronic obstructive pulmonary disease: a randomized, crossover study.

Abstract

PURPOSE:

Indacaterol is a novel, once daily, inhaled ultra-long-acting β₂-agonist for the treatment of chronic obstructive pulmonary disease (COPD). Here we compared the 24-h spirometry profile of once daily indacaterol 300 μg with that of placebo and twice daily salmeterol 50 μg in patients with COPD.

METHODS:

This randomized, multicenter, placebo-controlled, crossover study comprised three 14-day treatment periods (with 14-day washouts). Patients (male/female ≥ 40 years) with moderate-to-severe COPD were randomized to receive double-blind indacaterol 300 μg or placebo once daily, or open-label salmeterol 50 μg twice daily. The primary outcome measure was 24-h post-dose (trough) FEV₁ (mean of FEV₁ at 23 h 10 min and 23 h 45 min post-indacaterol dose) after 14 days. FEV₁ was assessed at multiple time points on Days 1 and 14 of each treatment period. Safety and tolerability were also monitored.

RESULTS:

Of 68 randomized patients, 61 completed. Trough FEV₁ (primary endpoint) on Day 14 for indacaterol was 200 mL higher than placebo (p < 0.001), exceeding the prespecified minimum clinically important difference (120 mL), and was 90 mL higher than for salmeterol (p = 0.011). After Day 1, trough FEV(1) for indacaterol was 150 mL higher than placebo (p < 0.001). Indacaterol provided superior bronchodilation compared with placebo (p < 0.001) across the full 24-h assessment period on Days 1 and 14. In addition, on both days, indacaterol provided superior FEV₁ compared with salmeterol (p < 0.05) at many post-baseline time points, including 5 min post-dose. All treatments were well tolerated.

CONCLUSIONS:

Once daily indacaterol 300 μg produced effective sustained 24-h bronchodilation from the first dose, an efficacy profile superior to placebo and twice daily salmeterol. Given its effective bronchodilation with once daily dosing, indacaterol is likely to be a useful treatment option for patients with moderate-to-severe COPD.

• Authors: Craig Laforce, Joseph Aumann, Luis de Teresa Parreño, Amir Iqbal, David Young, Roger Owen, Mark Higgins, Benjamin Kramer, INTEGRAL Study Investigators
• Journal: Pulmonary pharmacology & therapeutics (Pulm Pharmacol Ther) Vol. 24 Issue 1 Pg. 162-8 (Feb 2011) ISSN: 1522-9629 [Electronic] England
• PMID: 20619353 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Elsevier Ltd. All rights reserved.

Chemical References

• Adrenergic beta-2 Receptor Agonists
• Indans
• Quinolones
• indacaterol

Topics

• Adrenergic beta-2 Receptor Agonists (administration & dosage)
• Aged
• Cross-Over Studies
• Double-Blind Method
• Female
• Forced Expiratory Volume (drug effects)
• Humans
• Indans (administration & dosage, adverse effects)
• Male
• Middle Aged
• Pulmonary Disease, Chronic Obstructive (drug therapy, physiopathology)
• Quinolones (administration & dosage, adverse effects)