Boehringer Ingelheim announced the publication of new data from the phase IIIb OTEMTO 1 and 2 trials (NCT01964352/NCT02006732), which show Spiolto Respimat (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with chronic obstructive pulmonary disease (COPD). These data are published online in the journal Respiratory Medicine.
For COPD patients, breathlessness, among other symptoms, limits their ability to keep active and has a negative impact on their daily lives. As there is no cure for COPD, improving quality of life is a major goal of treatment. In COPD, quality of life is measured using the SGRQ; a reduction in SGRQ score of 4 points or more is deemed clinically meaningful. The OTEMTO trials show Spiolto Respimat provides a reduction in SGRQ total score of 4.67 versus placebo.
“The improvement in quality of life provided by Spiolto Respimat in these trials could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life,” said Dave Singh, professor of clinical pharmacology and respiratory medicine, University of Manchester and lead investigator of the OTEMTO trials. “For example, this could mean that patients are able to walk up stairs without stopping, go out to socialise with friends or find it easier to wash and dress. Essentially, the data show that patients feel much better.”
Further data from the 1,600 patient OTEMTO trials show Spiolto Respimat provides clinically meaningful improvements in breathlessness compared to placebo (measured by a 1.62 point improvement in TDI focal score), reflecting the meaningful quality of life benefits. It also provides consistent improvements in lung function, breathlessness and quality of life compared to Spiriva (tiotropium) as well as a safety profile similar to Spiriva or placebo. Incidence of adverse events was broadly similar across treatment groups, with a higher incidence of AEs leading to discontinuation in the placebo groups compared to the treatment groups.
OTEMTO 1&2 build on the pivotal phase III TONADO trials that demonstrated Spiolto Respimat provides significant improvements in lung function, breathlessness, quality of life and reduction in rescue medication use over Spiriva Respimat right from the initial disease stages when patients first need maintenance therapy. OTEMTO 1&2 are part of the >15,000 patient TOviTO phase III clinical trial programme, one of the largest trial programmes conducted in COPD.
US FDA recently accepted for review a Supplemental New Drug Application (sNDA) to include the OTEMTO quality of life data in the Stiolto Respimat label.
To date, Spiolto Respimat has gained approval in more than 20 EU/EEA countries, the US, Canada and Australia for use in the treatment of patients with COPD. Spiolto Respimat is built on tiotropium, the active ingredient in Spiriva - the world’s most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities. It is enhanced by olodaterol, a unique and effective long-acting beta2-agonist with a fast onset of action, specifically designed to complement the efficacy of Spiriva. Spiolto is delivered by Respimat, the only inhaler available that actively delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.
COPD is a chronic, progressive, treatable, but incurable lung disease that affects 210 million people worldwide. It is a growing world health priority and the WHO predicts it will become the 3rd leading cause of death by 2030.
For people with COPD, decreasing lung function causes breathlessness and stops them from being active. This can lead to a downward spiral of worsening symptoms and even further inactivity,16 contributing to an increased risk of disability and death.
When the majority of patients first go to see their doctor, their disease has already progressed to a point when they need maintenance treatment. For most patients at this point, lung function is declining at its fastest rate – quicker than in the later stages of the disease. Optimal management right from the start of maintenance therapy may give patients the best opportunity to manage their symptoms, stay active and maintain a good quality of life for as long as possible.