Kate Johnson

November 09, 2015

MONTREAL — For patients with moderate to severe chronic obstructive pulmonary disease (COPD), the dual bronchodilator combination of tiotropium plus olodaterol improves quality of life better than either therapy alone, according to an analysis of data from the Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) (TONADO) studies ( Eur Respir J. 2015;45:969-997).

The global assessment rate was significantly better with the combination than with monotherapy, which is "consistent with improvements seen in lung function, quality of life, and dyspnea," said investigator François Maltais, MD, from the Research Centre at the Institute of Cardiology and Pneumology at Laval University in Quebec City, Quebec, Canada.

"Although the magnitude of difference between the combination and monotherapy was slight, it was statistically significant," he added. "Overall, patients were feeling slightly better."

The secondary analysis of data from the phase 3 TONADO 1 and TONADO 2 studies was presented during a late-breaking session here at CHEST 2015: American College of Chest Physicians Meeting.

The subanalysis involved 3100 patients with COPD: 1033 were randomly assigned to once-daily tiotropium 5 μg, 1038 to olodaterol 5 μg, and 1029 to a combination of both drugs for 52 weeks.

"On average, baseline characteristics were well balanced," Dr Maltais reported. Three quarters of the population was male, mean age was about 64 years, and about one third of the patients were current smokers with a mean forced expiratory volume in 1 second of about 1.3 to 1.4 L.

Patients completed a questionnaire at weeks 12, 24, 40, and 52 of treatment and were asked to rate their global health assessment on a 7-point Likert scale.

The average patient global rating score was significantly lower with the combination than with monotherapy (P < .0001) after 24 and 52 weeks, said Dr Maltais.

Overall Health, Perceived Well-Being

The St. George's Respiratory Questionnaire of overall health, daily life, and perceived well-being demonstrated that the combination therapy was significantly better than monotherapy, as did the Mahler Baseline Dyspnea Index.

Girolamo Pelaia, MD, from the University Magna Græcia of Catanzaro in Italy, told Medscape Medical News that more effective dual bronchodilation makes it possible to achieve further improvements in subjective symptoms, lung function, and overall quality of life.

The rapidly acting and long-lasting beta2-agonist olodaterol "represents the ideal partner for tiotropium, the most studied and tested long-acting muscarinic antagonist in both controlled trials and clinical practice," Dr Pelaia said.

"The addition of olodaterol to tiotropium overcomes the only limit of such a highly valuable long-acting muscarinic antagonist: its relatively late onset of action," he said. "Once-daily delivery of tiotropium with olodaterol via a very efficient and simple-to-use inhaler device like Respimat [Boehringer Ingelheim] significantly contributes to enhance the therapeutic efficacy of dual bronchodilation, as well as to increase patient adherence to inhaled treatment."

Dr Maltais reports financial relationships with Altana Pharma, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Grifols, Merck, Novartis, Nycomed, and Pfizer and holds the Canadian Institutes of Health Research GlaxoSmithKline Research Chair on COPD.

CHEST 2015: American College of Chest Physicians Meeting. Presented October 27, 2015.

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