RIDGEFIELD, Conn., May 17, 2013 /PRNewswire/ — Boehringer Ingelheim will contribute to advancing the scientific discussion in respiratory disease at the American Thoracic Society International Conference (ATS 2013) in Philadelphia, PA, May 17 – 22. Data will highlight research conducted with a product approved for the treatment of chronic obstructive pulmonary disease (COPD) [Spiriva® HandiHaler® (tiotropium bromide inhalation powder)], as well as investigational compounds for asthma, idiopathic pulmonary fibrosis (IPF) and COPD.
The breadth of Boehringer Ingelheim data at ATS 2013, one of the largest gatherings of pulmonary clinicians and researchers in the world, reinforces the company’s commitment to lung health and to finding solutions for physicians and patients where unmet needs exist.
Boehringer Ingelheim’s abstracts in respiratory research can be accessed through the ATS website, http://conference.thoracic.org. The data will remain under embargo until the date and time that the data are presented (details below).
Tiotropium is being investigated to determine its efficacy and safety in treating patients with asthma and is not approved for this indication.
Nintedanib is being investigated to determine its efficacy and safety in treating patients with IPF and is not approved for this indication.
Olodaterol and tiotropium + olodaterol
Olodaterol and the combination of tiotropium plus olodaterol are being investigated to determine their efficacy and safety in treating patients with COPD and are not approved for this indication.
Tiotropium bromide inhalation powder
Tiotropium bromide inhalation powder, which is marketed as Spiriva® HandiHaler® in the U.S. by Boehringer Ingelheim and Pfizer, Inc., is a once-daily long-acting inhaled muscarinic antagonist (LAMA) indicated for both the maintenance treatment of bronchospasm (narrowing of the airways) associated with COPD, including chronic bronchitis and emphysema, and to reduce exacerbations.
Tiotropium is a long-acting anticholingeric bronchodilator currently being studied as a once-daily treatment in asthma patients who remain symptomatic despite use of maintenance therapy, including inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). Boehringer Ingelheim is developing the drug in a robust Phase 3 clinical trial program, UniTinA-asthma™, to evaluate its potential across a wide range of asthma patients. Despite current treatment options, approximately 40 percent of patients with asthma remain symptomatic. The UniTinA-asthma Phase 3 clinical trial program is designed to help address the unmet needs of appropriate patients who remain symptomatic despite current therapies.
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for IPF. It targets three growth factors: the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR). These receptors have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis. By blocking these signaling pathways that are involved in fibrotic processes, it is hypothesized that there may be potential to reduce disease progression, and thereby slow the decline of lung function. Nintedanib is also in clinical development and under evaluation as a possible treatment option for cancer, including non-small cell lung cancer, ovarian cancer, colorectal cancer and hepatocellular carcinoma.
Olodaterol is an investigational long-acting beta2-agonist (LABA) currently being studied as a once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Olodaterol’s efficacy as a once-daily bronchodilator in patients with COPD is being investigated in a robust clinical trial program, which has been conducted in a patient population representative of those seen in clinical practice.
About Spiriva® HandiHaler® (tiotropium bromide inhalation powder)
SPIRIVA HandiHaler is a prescription medicine used once every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing airways. COPD includes chronic bronchitis, emphysema or both.
SPIRIVA HandiHaler also reduces the likelihood of flare-ups (exacerbations), which are worsening of COPD symptoms (COPD exacerbations). A COPD exacerbation or flare-up is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath and wheezing that requires medicine beyond your rescue medicine.
Important Safety Information for Spiriva® HandiHaler® (tiotropium bromide inhalation powder)
Do not use SPIRIVA HandiHaler if you are allergic to tiotropium or ipratropium (e.g., Atrovent®) or any of the ingredients in SPIRIVA. If your breathing suddenly worsens, your face, throat, lips or tongue swells, you get hives, itching or rash, stop taking SPIRIVA and seek immediate medical help.
Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is not a rescue medicine and should not be used for treating sudden breathing problems.
Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HandiHaler device.
If you have vision changes or eye pain or if you have difficulty passing urine or painful urination, stop taking Spiriva® HandiHaler® (tiotropium bromide inhalation powder) and call your doctor right away.
Tell your doctor if you have glaucoma, problems passing urine or an enlarged prostate, as these may worsen with SPIRIVA. Tell your doctor if you have kidney problems or are allergic to milk proteins. Ask your doctor if you are not sure. Also discuss with your doctor all the medicines you take, including eye drops.
The most common side effect with SPIRIVA is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.
Do not let the powder from the SPIRIVA capsule get into your eyes.
Dizziness and blurred vision may occur with SPIRIVA. Should you experience these symptoms, you should use caution when engaging in activities such as driving a car or operating appliances or other machines.
Read the Patient Information and the step-by-step Instructions for Use for SPIRIVA before you use your inhaler.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For full prescribing information, please visit www.spiriva.com, or call 1-800-542-6257 option #4.
Click here for full Spiriva Prescribing Information, Patient Information and Instructions for Use.
Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company’s cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company’s goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.
In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). RD expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
For more information please visit www.us.boehringer-ingelheim.com