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Boehringer Ingelheim to Present Latest Data from Robust Respiratory Portfolio at American College of Chest Physicians (ACCP) Annual Meeting

October 24, 2013

Eleven presentations on investigational compounds and an approved product will be presented at the CHEST 2013 meeting

RIDGEFIELD, Conn., Oct. 24, 2013 /PRNewswire/ — Boehringer Ingelheim today announced the upcoming presentation of data from 11 abstracts, including 6 oral presentations, across the company’s respiratory portfolio at the 2013 American College of Chest Physicians (ACCP) annual meeting, CHEST 2013, taking place October 26 – 31 in Chicago. These data exemplify Boehringer Ingelheim’s continued commitment to lung health and to discovering new therapies for patients and physicians where unmet needs exist.

These data will highlight ongoing research from the company’s development programs for asthma and chronic obstructive pulmonary disease (COPD), and provide additional information on the once-daily COPD maintenance therapy, Spiriva(®) HandiHaler(®) (tiotropium bromide inhalation powder). Data from the TIOSPIR(TM) (Tiotropium Safety and Performance in Respimat) trial, one of the largest international COPD trials conducted to date, will also be presented.

Tiotropium in Asthma
The CHEST program includes a session titled “Tiotropium and Asthma”, which will feature four oral presentations from from the tiotropium development program for adults with severe persistent asthma, including one Phase 2 study and analyses from the PrimoTinA-asthma(®) Phase 3 trials. The presentations focus on new analyses and data, including expanded analyses of safety and exacerbation data. The PrimoTinA-asthma(®) studies are designed to evaluate once-daily tiotropium delivered via the Respimat(®) inhaler as add-on therapy to inhaled corticosteroid/long-acting beta agonists (ICS/LABA) in symptomatic patients with severe persistent asthma. Tiotropium delivered via the Respimat(®) inhaler is being investigated to determine its efficacy and safety in treating patients with asthma and is not approved for this indication.

    Title*                                 Presenting Author               Presentation Details
    -----                                  -----------------               --------------------

    Improvements in lung
     function with
     tiotropium as add-on
     controller therapy to
     ICS+LABA for patients
     with symptomatic
     severe asthma                         D. E. Doherty                   Session: Tiotropium and Asthma (Slides; ID 10747)

                                                                           Date: Monday, October 28

                                                                           Time: 1:45pm - 3:15pm CT
    ---                                    ---                                  ------------------------

    Once-daily tiotropium
     is well tolerated as
     add-on to standard
     treatment for
     patients with
     symptomatic asthma
     despite receiving
     inhaled
     corticosteroids and
     long-acting beta 2
     agonists                              J. Bernstein                    Session: Tiotropium and Asthma (Slides; ID 10747)

                                                                           Date: Monday, October 28

                                                                           Time: 1:45pm - 3:15pm CT
    ---                                    ---                                  ------------------------

    Once-daily tiotropium
     reduces risk of
     exacerbations and
     asthma worsening in
     patients with
     symptomatic asthma
     despite treatment
     with inhaled
     corticosteroids and
     long-acting beta 2
     agonists                              D. Tashkin                      Session: Tiotropium and Asthma (Slides; ID 10747)

                                                                           Date: Monday, October 28

                                                                           Time: 1:45pm - 3:15pm CT
    ---                                    ---                                  ------------------------

    Tiotropium as add-on
     therapy to ICS+LABA
     in patients with
     symptomatic severe
     asthma: spirometric
     assessment over 24
     hours                                 J. Corren                       Session: Tiotropium and Asthma (Slides; ID 10747)

                                                                           Date: Monday, October 28

                                                                           Time: 1:45pm - 3:15pm CT
    ---                                    ---                                  ------------------------

    *Data will remain under embargo until 12:00am CT on Monday, October 28

Olodaterol
Among the abstracts scheduled for presentation are results from a Phase 3 analysis assessing the effects of once-daily olodaterol on exercise endurance in COPD patients. Olodaterol is not currently approved and is being investigated to determine the drug’s efficacy and safety as a bronchodilator maintenance treatment for patients with COPD.

    Title*                               Presenting Author                  Presentation Details
    -----                                -----------------                  --------------------

    Evaluation of the
     effects of
     olodaterol on
     exercise endurance
     in patients with
     COPD: results from
     two 6-week studies                  F. Maltais                         Session: New Treatments for COPD (Slides; ID 10730)

                                                                            Date: Monday, October 28

                                                                            Time: 1:45pm - 3:15pm CT
    ---                                  ---                               ------------------------

    The 24-hour FEV1
     time profile of
     olodaterol once
     daily (QD) via
     Respimat(R) and
     formoterol twice
     daily (BID) via
     Aerolizer(R) in
     patients with COPD:
     results from two
     6-week studies                      G. J. Feldman                      Session: New Treatments for COPD (Slides; ID 10730)

                                                                            Date: Monday, October 28

                                                                            Time: 1:45pm - 3:15pm CT
    ---                                  ---                               ------------------------

    Efficacy of
     olodaterol once
     daily (QD) via
     Respimat(R) in GOLD
     2/3 COPD patients
     not receiving
     background therapy:
     pooled data from
     48-week studies                     G. T. Ferguson                     Poster Board # 2485

                                                                            Session: COPD Safety of Treatment (Poster; ID 10702)

                                                                            Date: Wednesday, October 30

                                                                            Time: 1:30pm - 2:30pm CT
    ---                                  ---                               ------------------------

    Pooled cardiac
     safety analysis of
     48-week
     administration of
     olodaterol once
     daily (QD) via
     Respimat(R) versus
     placebo and
     formoterol twice
     daily (BID) in
     patients with COPD                  P. Sachs                           Poster Board # 2479

                                                                            Session: COPD Safety of Treatment (Poster; ID 10702)

                                                                            Date: Wednesday, October 30

                                                                            Time: 1:30pm - 2:30pm CT
    ---                                  ---                               ------------------------

    Pooled safety
     analysis of                          adverse events
     olodaterol QD via
     Respimat(R) versus
     placebo and
     formoterol BID in
     patients with COPD:
     independently
     adjudicated
     respiratory-
     related severe                                                         Poster Board # 2470

                                                                            Session: COPD Safety of Treatment (Poster; ID 10702)

                                                                            Date: Wednesday, October 30

                                                                            Time: 1:30pm - 2:30pm CT
    ---                                  ---                               ------------------------

    *Data will remain under embargo until 12:00am CT on Monday, October 28

Tiotropium Bromide Inhalation Powder
New data from the TIOSPIR(TM) trial comparing the safety and efficacy of once-daily tiotropium delivered via two inhalers — Respimat(®) and HandiHaler(®) — was accepted as a late-breaker presentation. The abstracts below present data from the TIOSPIR(TM) trial and a separate post-hoc analysis of sex differences in physical activity in individuals with untreated mild-to-moderate COPD.

Spiriva(® )HandiHaler(®) (tiotropium bromide inhalation powder) 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 delivered via the Respimat(®) inhaler is under clinical development and is not yet approved in the United States.

    Title*                               Presenting Author                 Presentation Details
    -----                                -----------------                 --------------------

    The Tiotropium                       A. Anzueto                         Session: COPD Original
     Safety                                                                 Investigations (Slides; ID 11134)

    and Performance in Respimat                                              Date: Wednesday, October 30

    (TIOSPIR) trial: bronchodilator                                          Time: 2:45pm - 4:15pm CT

    efficacy in a spirometry substudy
    ---------------------------------                                                                        ---

    Sex differences in
     physical                            J. Guenette                       Poster Board # 2455

    activity levels and dyspnea in                                          Session: COPD Diagnosis & Evaluation
                                                                            (Poster; ID 10703)

    mild-to-moderate COPD                                                  Date: Wednesday, October 30

                                                                           Time: 1:30pm - 2:30pm CT
    ---                                  ---                                  ------------------------

    *Data will remain under embargo until 12:00am CT on Monday, October 28

About Tiotropium in Asthma
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. 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.

About Olodaterol
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 each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. 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).

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 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.

Click here for full Spiriva Prescribing Information, including Patient Information and Instructions for Use.

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.

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.

Social responsibility is a central element of Boehringer Ingelheim’s culture. 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). R&D 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

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.


Source: PR Newswire