August 20, 2015
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Stiolto Respimat helps improve QOL in patients with COPD

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Stiolto Respimat helped improve quality of life and lung function in patients with COPD, according to study results.

Gary T. Ferguson, MD, the director of Pulmonary Research Institute of Southeast Michigan, and colleagues conducted two replicate, double blind, placebo-controlled, parallel-group phase 3b trials to assess the efficacy of Stiolto Respimat on lung function and health-related quality of life compared with placebo in patients with moderate to severe COPD.

The analysis included 812 adults aged 40 years and older in the first trial and 809 adults in the second trial.

Participants received one of four treatments once a day for 12 weeks, all delivered by the Respimat inhaler. Participants either received placebo, tiotropium 5 µg, Stiolto Respimat (tiotropium bromide and olodaterol, Boehringer Ingelheim) 2.5/5 µg or Stiolto Respimat 5/5 µg.

The highest dose of the drug significantly improved patient quality of life as assessed by St. George’s Respiratory Questionnaire (SGRQ). The combination drug improved SGRQ score at 12 weeks by 4.89 units in the first trial group and 4.56 units in the second vs. placebo (P < .0001 for both).    

The highest dose also improved trough forced expiratory volume in 1 second after 12 weeks by 0.162 L in the first trial and 0.166 L in the second trial compared with placebo (P < .0001 for both).

The combination drug is beneficial for patients with moderate to severe COPD, according to Ferguson.

“In the recent publication of the [phase 3b] trials, Stiolto Respimat improved the SGRQ scores by more than four points, which is considered the minimum clinically important difference for this measure of health-related quality of life among COPD patients,” he said in a press release. “These data add to the growing body of evidence for Stiolto Respimat, which has been clinically proven to significantly improve lung function compared to tiotropium Respimat, olodaterol Respimat and placebo with a similar safety profile.” – by Ryan McDonald  

Disclosure: Ferguson reports receiving grants, personal fees and non-financial support from Boehringer Ingelheim. Please see the full study for a list of Ferguson’s and all other researchers’ relevant financial disclosures.