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Indacaterol Improves Day and Nigh Symptoms in Patients With COPD: Presented at ERS

By Evelyn Harvey

VIENNA, Austria -- September 22, 2009 -- Once-daily indacaterol improves day and nighttime symptoms associated with chronic obstructive pulmonary disorder (COPD), according to a study presented here on September 14 the 19th Annual Congress of the European Respiratory Society (ERS).

In addition, results of the Indacaterol vs Tiotropium to Help Achieve New COPD Treatment Excellence (INHANCE) study also showed that the use of rescue medication declined in patients who received indacaterol, when compared with tiotropium or placebo.

The results of the INHANCE study were presented as a series of poster presentations during the meeting. The current study by Jan Lötvall, University of Gothenburg, Gothenburg, Sweden, and colleagues, focused on the safety and efficacy of indacaterol on day and night symptoms of COPD, compared with tiotropium or placebo.

The study included patients aged 40 years and older with moderate to severe COPD and a smoking history of >=20 packs per year. Patients were randomised to receive double-blind, once-daily indacaterol 150 mcg (n = 416), open-label indacaterol 300 mcg (n = 416), tiotropium 18 mcg (n = 415), or placebo (n = 418) for 26 weeks. Rescue therapy was permitted as needed.

Patients recorded symptoms and related variables in daily diary cards. Bronchodilator efficacy was also measured. The primary endpoint was trough forced expiratory volume in 1 second (FEV₁) after 12 weeks.

Both doses of indacaterol were significantly superior to placebo and tiotropium in increasing trough FEV₁ in patients after 1 day, 12 weeks, and 26 weeks of treatment (P < .05 for all).

Diary card data indicated that indacaterol significantly improved day and night symptoms of COPD, with patients on both indacaterol doses reporting fewer night awakenings, more days able to perform normal activities, and reduced daytime symptoms than patients on placebo or tiotropium.

Significant reductions in the use of rescue mediations were seen in patients on either dose of indacaterol compared with placebo or tiotropium (P < .001 vs placebo or tiotropium).

The incidence of adverse events was similar across the 4 groups in the study.

Funding for this study was provided by Novartis Pharma AG.

[Presentation title: Indacaterol Once-Daily Improves Day and Night-Time Symptom Control in COPD Patients: A 26-Week Study Versus Placebo and Tiotropium. Abstract P2029]

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