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Indacaterol: in chronic obstructive pulmonary disease.

¹Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz

|November 18, 2010

Summary

Indacaterol, a once-daily maintenance treatment for chronic obstructive pulmonary disease (COPD), demonstrated significant bronchodilation and improved lung function in patients. It also showed benefits in reducing exacerbations and improving quality of life compared to placebo and other treatments.

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Area of Science:

Pharmacology
Respiratory Medicine
Clinical Trials

Background:

Chronic obstructive pulmonary disease (COPD) is a major cause of airflow obstruction.
Long-acting bronchodilators are essential for COPD maintenance therapy.
Indacaterol is a novel long-acting beta2-adrenoceptor agonist (LABA).

Purpose of the Study:

To evaluate the efficacy and safety of indacaterol in adult patients with COPD.
To assess the bronchodilatory effect and duration of action of indacaterol.
To compare indacaterol with placebo and other bronchodilators in COPD management.

Main Methods:

Four large, randomized, double-blind, placebo-controlled, multicentre phase III trials were conducted.
Patients with moderate to severe COPD received indacaterol (150 or 300 μg once daily), placebo, formoterol, salmeterol, or tiotropium.
Primary endpoint was mean trough forced expiratory volume in 1 second (FEV1) after 12 weeks.

Main Results:

Indacaterol significantly improved mean trough FEV1 compared to placebo (130-180 mL difference).
Improvements in FEV1 exceeded the clinically relevant threshold of 120 mL in all trials.
Indacaterol showed superior FEV1 compared to formoterol, salmeterol, and tiotropium.
Significant improvements in COPD exacerbations, symptoms, and quality of life were observed with indacaterol versus placebo in some studies.
Indacaterol was generally well tolerated.

Conclusions:

Indacaterol provides rapid and sustained 24-hour bronchodilation for once-daily COPD maintenance therapy.
Indacaterol demonstrates significant and clinically relevant improvements in lung function compared to placebo and other bronchodilators.
Indacaterol is a well-tolerated treatment option for patients with moderate to severe COPD.