New Data: Stiolto Respimat inhalation spray significantly improved exercise capacity in people with COPD
Tiotropium+olodaterol Respimat along with exercise training and behavior modification significantly increased exercise capacity compared to placebo.
Boehringer Ingelheim has announced the first results from the Phase IIIb/IV PHYSACTO trial that showed Stiolto Respimat, combined with exercise training, helps people with chronic obstructive pulmonary disease (COPD) walk for longer periods of time compared with those receiving placebo. All participants of the trial were also enrolled in a self-management behaviour modification programme, which provided health education and skills to help better manage COPD. These data were presented today at the European Respiratory Society (ERS) International Congress 2016 in London.
In the PHYSACTO trial, exercise capacity was measured by the length of time people with COPD could walk in an Endurance Shuttle Walking Test, which measures how far someone can walk at a standard speed without stopping for a rest.
After 8 weeks, in the tiotropium+olodaterol Respimat combined with exercise training arm, exercise capacity in people with moderate-to-severe COPD significantly increased by 45.8%, compared to those receiving placebo with no exercise training (356 vs. 244 seconds respectively). Furthermore, tiotropium+olodaterol Respimat was shown to reduce shortness of breath (dyspnea) associated with physical activity, compared to placebo.
Long-acting beta(2)-adrenergic agonists, such as olodaterol, one of the active ingredients in Stiolto Respimat, increase the risk of asthma-related death. Stiolto Respimat is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms. Stiolto Respimat is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product. As with other inhaled medicines, Stiolto Respimat may cause paradoxical bronchospasm that may be life-threatening. The most common adverse reactions were nasopharyngitis, cough and back pain.
"It is vital for people with COPD to stay active as this may help slow the progression of disease burden," said study investigator Professor Thierry Troosters, Head, Research Group for Cardiovascular and Respiratory Rehabilitation, University of Leuven, Belgium. "This new study is the first to demonstrate that a holistic approach to COPD management, which includes behaviour modification enriched with exercise training and effective long acting bronchodilator therapy, can improve exercise capacity and reduce shortness of breath."
Related News
-
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. -
News CPHI Podcast Series: Why we need to consider women in clinical trials
The latest episode of the CPHI Podcast Series with Lucy Chard covers women's health, specifically women's representation in clinical trials, the associated bias, and the impacts on health for this population. -
News US FDA does not approve MDMA therapy for PTSD, requests more data
The MDMA-based therapeutic developed by Lykos Therapeutics, a California-based Public Benefit Corporation (PBC), has been reviewed and unapproved by the US FDA. The regulator has requested additional phase III trial data for further safety and efficacy... -
News Novartis and Viatris latest facing lawsuit over HeLa cell misuse
Global pharmaceutical companies Novartis and Viatris are the latest hit with a lawsuit claim pertaining to alleged misuse of the ‘HeLa’ cell line from the estate of woman whose cancerous tissue cells were taken without consent. -
News Sanofi invests billions into Frankfurt insulin production site
French pharmaceutical company Sanofi have announced an investment of EUR1.3 billion at their existing BioCampus site in Frankfurt am Main for the expansion of insulin production. -
News Novel oral Type 1 diabetes drug gains US FDA IND designation
A University of Alabama at Birmingham startup has gained FDA clearance for Investigational New Drug clinical trials for an oral Type 1 diabetes drug, a milestone for diabetes treatment. -
News A Day in the Life of a Vice President in R&D & Engineering
In the Day in the Life of Series, we've already had the chance to get to know a range of people in various roles in the pharma industry. In the latest interview we get a glimpse into the R&D side of things from Jennifer Sorrells, Vice Presiden...
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