COPD fixed-dose combo enhances lung function

Because lung function can be substantially reduced by the time most chronic obstructive pulmonary disease (COPD) patients first see a physician, maintenance treatment should be considered at the time of diagnosis, according to new data analyses presented at the American Thoracic Society (ATS) 2015 International Conference.

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In the pivotal phase 3 TONADO 1 and 2 studies, which explored the efficacy and safety of investigational tiotropium/olodaterol delivered via the Respimat inhaler for COPD, compared to the individual components alone, tiotropium/olodaterol Respimat demonstrated a statistically significant improvement in lung function compared to tiotropium and olodaterol alone for COPD patients across all stages of the disease (A-D).

The analyses presented at ATS showed that in comparison to tiotropium Respimat 5 μg and olodaterol Respimat 5 μg, tiotropium/olodaterol Respimat 5/5 μg:

• Improved lung function, as measured by trough FEV₁, in patients who were untreated and/or previously treated with maintenance bronchodilator therapy

• Provided statistically significant improvements in lung function, as measured by trough FEV₁ and FEV₁AUC_0-3, in patients across all COPD stages

• Demonstrated statistically significant improvement of lung function irrespective of whether patients were taking inhaled corticosteroids (ICS) at the start of the trials

A safety analysis found tiotropium/olodaterol Respimat 5/5 μg had a comparable safety profile to tiotropium Respimat 5 μg or olodaterol Respimat 5 μg alone.

NEXT: TONADO 1 and 2 studies

TONADO 1 and 2 were 52-week, double-blind, parallel-group studies in which patients with moderate to very severe COPD were randomly assigned to receive olodaterol 5 μg, tiotropium 2.5 μg, tiotropium 5 μg, tiotropium/olodaterol 2.5/5 μg or tiotropium/olodaterol 5/5 μg, all delivered via the Respimat inhaler. These studies are part of a large phase 3 clinical trial program (TOviTO) for tiotropium/olodaterol Respimat, which includes more than 15,000 people with varying severities of COPD worldwide.

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Dr McBryan“Because lung function can be substantially reduced by the time most COPD patients first see a physician, maintenance treatment should be considered at the time of diagnosis,” said Boehringer Ingelheim's vice president of respiratory clinical development & medical affairs Danny McBryan, MD.

“While no treatment slows the rate of decline, these analyses showed that tiotropium/olodaterol Respimat demonstrated a statistically significant improvement in lung function compared to tiotropium and olodaterol alone for COPD patients across all stages of the disease [A-D],” Dr McBryan said.

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