Boehringer Ingelheim has announced new data analyses from the pivotal Phase III TONADO® 1&2 studies.
Data showed tiotropium/olodaterol Respimat® provided lung function benefit to patients with chronic obstructive pulmonary disease (COPD) from the start of maintenance therapy, with greatest benefit shown in the early stages of the disease. These data were presented yesterday at the American Thoracic Society Congress 2015.
The analyses showed:
- Tiotropium/olodaterol Respimat provided over 100% numerical improvement in Trough FEV1 compared to Spiriva® (tiotropium) Respimat in 24 weeks treatment in patients who had no prior maintenance bronchodilator therapy at baseline (148ml vs 72ml)
- Tiotropium/olodaterol Respimat provided improvement in lung function compared to Spiriva Respimat in patients across all COPD stages. Greater improvements were seen in patients at GOLD 2.
- Tiotropium/olodaterol Respimat had a comparable safety profile to Spiriva Respimat or Striverdi (olodaterol) Respimat alone
Respimat inhaler helps patients inhale medication deep into the lungs
Roland Buhl, Professor of Medicine and Head of the Pulmonary Department at Mainz University Hospital, Germany said, “These new data analyses for tiotropium/olodaterol Respimat are encouraging. When the majority of patients first see their doctor, their lung function has already greatly decreased.
“In COPD, decreasing lung function causes shortness of breath which can lead to a downward spiral of reduced physical activity, worsening of symptoms and even further inactivity. The new analyses suggest that tiotropium/olodaterol Respimat may help improve lung function from the early stages of the disease when patients are likely to be beginning maintenance therapy.”
Tiotropium/olodaterol is administered via Respimat, the platform inhaler for Boehringer Ingelheim’s respiratory therapies, including approved and investigational therapies. It is the only inhaler available that actively delivers a unique mist which is slow-moving, long lasting and consists of fine droplets. These features of the mist help patients inhale the medication deep into the lungs.
Welcoming the news Dr Charles de Wet, Medical Director UK and Ireland said, “Boehringer Ingelheim has long been an industry leader in the discovery and development of therapies for respiratory diseases, including COPD.
“Tiotropium/olodaterol Respimat builds on years of experience with tiotropium. We will continue to work with regulatory authorities and hope to make this treatment available for patients and their healthcare providers soon.”
New analyses show tiotropium/olodaterol Respimat effective irrespective of inhaled corticosteroid (ICS) use
A further new analysis from the TONADO studies showed that almost 40% of patients with less severe COPD (GOLD A/B) were taking ICS at the start of the trials. GOLD guidelines recommend the use of ICS only in patients with more severe lung function impairment and at high risk of exacerbations (GOLD C/D).
Irrespective of whether patients were taking ICS at the start of the trials data showed that tiotropium/olodaterol Respimat significantly improved lung function over Spiriva Respimat (133ml improvement in patients with ICS usage (p<0.001 vs. Tio 5μg) vs. 149ml in patients with no ICS usage (p<0.001 vs. Tio 5μg)).
