New Data Show Stiolto Respimat Provides Clinically Meaningful Improvements in COPD Health-Related Quality of Life Measure
Boehringer Ingelheim has announced the publication of new data from the Phase IIIb OTEMTO 1&2 trials, which show Stiolto Respimat provided clinically meaningful improvements in SGRQ total score, compared with placebo, in patients with chronic obstructive pulmonary disease (COPD). These data are published online in the journal, Respiratory Medicine.
COPD, which includes chronic bronchitis and emphysema, is a serious but treatable lung disease that can negatively impact a patient's ability to breathe. Along with improving lung function, another major goal of treatment is improving health-related quality of life.
In COPD, health-related quality of life is commonly measured using the SGRQ, a disease-specific patient-reported instrument that evaluates symptoms, activity limitation and the social and emotional impact of the disease. A reduction in SGRQ score represents an improvement, while a reduction of 4 points or more compared with placebo is considered clinically meaningful. In the OTEMTO trials, patients taking Stiolto Respimat reported a reduction in SGRQ total score of 4.67* points compared with placebo.
"In the recent publication of the OTEMTO trials, Stiolto Respimat improved the SGRQ scores by more than 4 points which is considered the minimum clinically important difference for this measure of health-related quality of life among COPD patients," said Gary T. Ferguson, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan, and study investigator. "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."
Data from the OTEMTO studies are included in an sNDA currently under review by the FDA.
Stiolto Respimat was approved in May 2015 for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Stiolto Respimat is not indicated to treat asthma or acute deterioration of COPD.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance