COPD fixed-dose combo enhances lung function

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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.

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 FEV1AUC0-3, 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.

Related:Study details problems with COPD drug

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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