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Once-Daily Ultibro Breezhaler Superior to Twice-Daily Seretide Accuhaler in Reducing COPD Flare-Ups

Exacerbations reduced by 31%

Once-daily Ultibro Breezhaler (indacaterol/glycopyrronium bromide, Novartis) has been shown to be superior in reducing exacerbations (flare-ups) and in improving lung function compared with twice-daily Seretide Accuhaler (salmeterol/fluticasone [SFC], GlaxoSmithKline) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

The new data were presented at the European Respiratory Society (ERS) International Congress, held September 6–10 in Munich, Germany.

The LANTERN trial was a randomized, double-blind, parallel-group, 26-week study involving 744 patients in China, Taiwan, Argentina, and Chile. The study’s primary objective was to demonstrate the non-inferiority of Ultibro Breezhaler 110/50 mcg to SFC 50/500 mcg in terms of lung function (trough forced expiratory volume in 1 second [FEV1]) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year. Ultibro Breezhaler demonstrated non-inferiority and superior efficacy compared with SFC for the primary objective.

The Ultibro device significantly reduced the rate of moderate-to-severe exacerbations by 31% compared with SFC. In addition, patients treated with Ultibro Breezhaler had significantly increased lung function (trough FEV1 = 0.075 L [P 0–4h] = 0.122 L [P

According to the product’s developer (Novartis), the new findings support the use of Ultibro Breezhaler as a steroid-free alternative to SFC in patients with moderate-to-severe COPD. This approach is consistent with the Global Initiative for Chronic Obstructive Lung Disease 2014 guidelines.

Clinical trials have shown that Ultibro Breezhaler offers statistically significant improvements in bronchodilation compared with treatments widely used as current standards of care, including SFC 50/500 mcg and open-label tiotropium (18 mcg). The inhaler is currently approved for use in more than 40 countries, including E.U. members, Japan, Canada, countries in Latin America, and Australia.

COPD symptoms can have a major negative effect on a patient’s ability to breathe and function, reducing his or her quality of life. Essential daily activities, such as climbing stairs, can become difficult as the condition gradually worsens. Many patients remain symptomatic despite medical therapy.

Source: Novartis; September 7, 2014.

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