As the highly-competitive chronic obstructive pulmonary disease market expands, a study has been published which claims to show that Novartis' new treatment Onbrez provides improved clinical benefits compared with Boehringer Ingelheim/Pfizer's blockbuster Spiriva.

The study, published in the European Respiratory Journal, shows that once-daily Onbrez Breezhaler (indacaterol) was as effective as Spiriva (tiotropium) in improving lung function in COPD patients. It also demonstrates that the Novartis treatment provides "significantly greater clinical benefit in terms of reduced shortness of breath, lower use of reliever medication and improved capacity for day-to-day activities," the Swiss major says.

The study, INTENSITY, is the first, blinded, head-to-head study whose primary aim was to compare indacaterol with tiotropium. About 1,600 patients with moderate-to-severe COPD were enrolled in the study and they received once-daily treatment with either 150mcg indacaterol or 18mcg tiotropium. Top-line results were presented last November.

The study met its primary endpoint by demonstrating non-inferiority of Onbrez to Spiriva after 12 weeks in terms of lung function measured by forced expiratory volume of breath in one second (FEV1). However in terms of secondary endpoints, indacaterol won out in terms of improvements in shortness of breath (2.01 vs 1.43 using the transition dyspnoea index), a higher proportion of days without reliever medication (46.1% vs 41.4%) and improved quality-of-life (mean change of -5.1 vs -3.0 in St George’s Respiratory Questionnaire).

The INTENSITY study found that both treatments were well-tolerated, with similar incidence of adverse events reported (39.7% versus 37.2% of patients using indacaterol and tiotropium respectively). The most common adverse event in this study was COPD worsening, cough and nasopharyngitis.

Novartis quoted Paul Jones at St George's Hospital, Tooting as saying that patients who received indacaterol in routine practice "are also more likely to experience an improvement in their wellbeing and symptoms, particularly shortness of breath, than with tiotropium". He added that "this represents a significant advance".