Glycopyrronium Bromide Powder Inhaler Helpful in COPD

August 14, 2012

By David Douglas

NEW YORK (Reuters Health) Aug 10 - For patients with moderate to severe chronic obstructive pulmonary disease (COPD) in the phase III GLOW2 trial, the antimuscarinic glycopyrronium bromide (NVA237) did significantly better than placebo and at least as well as tiotropium bromide (Spiriva).

"With its rapid efficacy (within five minutes on day one), good safety profile, and excellent 0-24 hour forced expiratory volume in one second (FEV1) performance similar or superior to tiotropium, NVA237 50 mcg looks to be beneficial for patients with COPD, and may help reduce moderate and severe exacerbations," lead investigator Dr. Edward M. Kerwin told Reuters Health by email.

Last fall, Novartis announced that in two other phase III studies (GLOW 1 and GLOW 3), patients taking NVA237 had superior bronchodilation and exercise endurance compared to those in a placebo group. NVA237 also prolonged time to first moderate to severe COPD exacerbation and reduced associated hospitalizations. Based on the results, Novartis submitted NVA237 last year for approval in Europe and Japan.

The GLOW-2 data, announced in May at the American Thoracic Society meeting, are detailed in a July 26 paper in the European Respiratory Journal by Dr. Kerwin of the Clinical Research Institute of Southern Oregon in Medford and colleagues.

Participants were randomly assigned to receive dry-powder NVA237 50 mcg, placebo or open-label tiotropium 18 mcg. In all, 810 patients completed the 52-week study.

The primary end-point -- trough lung function (forced expiratory volume in one second, or FEV1) at 12 weeks -- increased significantly from baseline compared to placebo in both the NVA237 (by 97 mL) and tiotropium groups (by 83 mL).

In fact, Dr. Kerwin said, the agent provides substantial airway improvements over placebo (ranging from 91-134 mL), which were sustained from day one until week 52. Also, he said, "dyspnea, health status and albuterol use were significantly improved by NVA237 versus placebo, and moderate-severe exacerbations risk was reduced by 34%."

Safety profiles were similar. More patients in the placebo group discontinued (28.3%), compared to those in the NVA237 (22.3%) and tiotropium groups (23.1%).

Long-acting muscarinic antagonists (LAMAs) "have been very successful in controlling COPD symptoms, improving airway function, and reducing exacerbations, but until recently there has been only a single LAMA, tiotropium, widely marketed," Dr. Kerwin said.

This new LAMA, he concluded, "whether as a monotherapy, or potentially combined with other COPD medicines such as indacaterol, shows considerable promise as a simple, clinically beneficial once-daily treatment for COPD."

Commenting on the U.S. status of the agent, Christina Clinton, global head of franchise communications at Novartis Pharmaceuticals in Basel, Switzerland, told Reuters Health by email the company expects to file for approval of NVA237 early in 2014.

The study was sponsored by Novartis Pharma AG, and six of the eight authors are with Novartis in the UK or US.

In Europe, the company hopes to market the product as Seebri Breezhaler.

SOURCE: http://bit.ly/OXA2IN

Eur Respir J 2012.

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