New phase-II data show that NVA237 (glycopyrronium bromide), a novel inhaled long-acting muscarinic antagonist (LAMA), provides sustained 24-hour bronchodilation in patients with moderate-to-severe COPD. NVA237 showed similar efficacy and duration of action to tiotropium with potentially a more rapid onset of action.

In addition, studies lasting up to 28 days showed that NVA237 was safe and well tolerated with no clinically relevant cardiovascular findings. The results were presented at the annual congress of the European Respiratory Society (ERS) in Berlin, Germany.

Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that currently affects 210 million people worldwide and is projected to be the third leading cause of death by 2030. While there is no cure, bronchodilators such as LAMAs make breathing easier by enlarging the patient's airways, and are recognized in international guidelines as first-line treatment for COPD.

"COPD is a complex and debilitating disease that can have a devastating impact on patients and their families," said Prof Claus Vogelmeier of the University Hospital Giessen and Marburg, Germany. "There is a need for new therapies that give instant relief from debilitating symptoms such as shortness of breath, and provide a sustained benefit that can help to improve patients' quality of life."

Novartis is developing a comprehensive range of therapies for patients with respiratory diseases. NVA237 is an important element in the portfolio of once-daily inhaled drugs and is also being investigated as a possible fixed-dose combination with the novel once-daily long-acting beta2-agonist QAB149, currently in phase-III development.

One of the randomized, double-blind, placebo-controlled studies compared NVA237 (12.5, 25, 50 and 100µg once-daily) with placebo and open-label tiotropium. In the study involving 83 patients, all doses of NVA237 showed rapid onset of action and sustained 24-hour bronchodilation over the seven-day treatment period.

Clinically relevant improvements (i.e. >120mL more than placebo) in forced expiratory volume in one second (FEV1), a standard measure of lung function, were observed with both the 50 and 100µg doses of NVA237. Early post-dose spirometry data suggested a more rapid onset of action than tiotropium. During the study, NVA237 was well tolerated with a good overall safety profile.

The other study evaluated the safety and tolerability of NVA237 (100 and 200µg once-daily) in 250 patients during 28 days of treatment. In this study both doses were safe and well tolerated, with no clinically significant changes seen in vital signs or other cardiac monitoring. NVA237 provided sustained 24-hour bronchodilation over the study period. The authors concluded that NVA237 should be further evaluated for the treatment of COPD.

The results of the latest studies are consistent with previous clinical studies with NVA237 which demonstrated a potentially faster onset of action than tiotropium (five minutes versus 20-30 minutes) and a good overall safety and tolerability profile.

"Novartis is committed to the development of innovative, once-daily inhaled products that provide immediate and sustained bronchodilation to relieve the symptoms of airway obstruction," said Trevor Mundel, head of Global Development Functions at Novartis Pharma AG. "Our extensive late-stage portfolio of once-daily and fixed-dose combination inhaled products is designed to address the unmet need in respiratory diseases, and we look forward to moving forward with the development of these therapies as rapidly as possible."

NVA237 was licensed to Novartis in 2005 by Sosei Group Corporation and Vectura Group plc.