RIDGEFIELD, Conn., May 5, 2015 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that 29 abstracts from the company’s respiratory portfolio will be presented at the 2015 American Thoracic Society (ATS) International Conference taking place May 15-20 in Denver, including data on investigational therapies for chronic obstructive pulmonary disease (COPD) and asthma, and on approved products for idiopathic pulmonary fibrosis (IPF) and COPD. Of the 29 accepted abstracts, 19 are on COPD, including key data from the Phase III TONADO trials of late-stage, investigational tiotropium/olodaterol Respimat®.
“We are proud of our long-standing commitment to ongoing innovation in discovering and developing new treatments for serious lung conditions where there is an unmet need,” said Danny McBryan, MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “We look forward to sharing our asthma, IPF and late-stage COPD data at ATS, as we continue to advance our portfolio of respiratory products.”
Boehringer Ingelheim’s abstracts can be accessed through the ATS conference website, http://conference.thoracic.org. The data will remain under embargo until the date and time of presentation (details below). The breadth of data being presented at the meeting showcases the company’s latest contributions to respiratory research.
In addition to the data presentations, Boehringer Ingelheim will provide attending healthcare professionals with several educational opportunities, including an Industry Theater Presentation, “The Role of Bronchodilators in the Long-Term Maintenance Treatment of Patients With COPD: A Review of the Data” (May 18 at 11:45 am MT), and a dinner symposium featuring a panel of experts, “Selection of Long-Term Maintenance Therapy for Patients With COPD” (May 19 at 6:30 pm MT).
Chronic Obstructive Pulmonary Disease (COPD) Presentations
Sub-analyses from the TONADO trials investigating the safety and efficacy of tiotropium/olodaterol RESPIMAT in patients with COPD will be presented.
Tiotropium/olodaterol RESPIMAT is an investigational maintenance treatment for patients with COPD and includes tiotropium, the active ingredient in SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray and Spiriva® HandiHaler® (tiotropium bromide inhalation powder), combined with olodaterol. Tiotropium/olodaterol RESPIMAT is not currently approved and its efficacy and safety is being evaluated. Additional analyses will also be presented from the ANHELTO studies of SPIRIVA HandiHaler and olodaterol RESPIMAT versus SPIRIVA HandiHaler alone, as well as the WISDOM trial evaluating the stepwise withdrawal of inhaled corticosteroids (ICS) in COPD. Also being presented are further analyses from the TIOSPIR trial comparing SPIRIVA RESPIMAT and SPIRIVA HandiHaler.
Title | Lead / Presenting Author | Presentation Details |
Stepwise Withdrawal Of Inhaled Corticosteroids In COPD Patients Receiving Dual Bronchodilators: Lung Function Reduction In The WISDOM Study | H. Watz | Oral Presentation #B95 Date: Monday, May 18, 2015 Session Time: 2:15pm 4:15pm MT |
Withdrawal Of Inhaled Corticosteroids And Exacerbations Of COPD: The WISDOM Phenotyping Substudy | E.D. Bateman | Poster #616 Date: Tuesday, May 19, 2015 Session Time: 9:30am 11:30am MT |
Effects Of 6 Weeks’ Treatment With Once-Daily Tiotropium And Olodaterol Fixed-Dose Combination On Inspiratory Capacity And Exercise Endurance In Patients With COPD: The MORACTO Studies | D. O’Donnell | Poster #609 Date: Tuesday, May 19, 2015 Session Time: 9:30am 11:30am MT |
Validation of a Patient-Level Markov Model of Bronchodilator Maintenance Treatment In Chronic Obstructive Pulmonary Disease | C. Selya-Hammer | Poster #109 Date: Tuesday, May 19, 2015 Session Time: 2:15pm 4:15pm MT |
Pooled Safety Analysis Of Adjudicated Serious Adverse Events With The Fixed-Dose Combination Of Tiotropium + Olodaterol | R. Buhl | Poster #P523 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Analysis Of The Efficacy And Safety Of The Fixed-Dose Combination Of Tiotropium + Olodaterol In Patients With COPD By Initial Disease Severity | S. Korn | Poster #P519 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Analysis Of The Efficacy And Safety Of The Fixed-Dose Combination Of Tiotropium + Olodaterol In Patients With COPD By Previous Usage Of Inhaled Corticosteroids | S. Korn | Poster #P522 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Tiotropioum + Olodaterol Fixed Dose Combination Therapy Provides Lung Function Benefits When Compared With Tiotropium Alone, Irrespective Of Prior Treatment With A Long-acting Bronchodilator: Post-hoc Analyses Of 2 One-year Studies | R. Buhl | Poster #P522 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Tiotropioum + Olodaterol Fixed Dose Combination Therapy Provides Lung Function Benefits Compared With Tiotropium Alone In Patients with GOLD A/B And C/D Chronic Obstructive Pulmonary Disease: Post-hoc Analyses Of 2 One-year Studies | R. Buhl | Poster #P524 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Inhaled Corticosteroid Plus Long-acting beta2-agonist Therapy Is Overused In The Treatment of Patients With Chronic Obstructive Pulmonary Disease: Post-hoc Analyses Of 2 One-year Studies | H. Watz | Poster #P554 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Characteristics Of COPD Patients With And Without Maintenance Treatment At Baseline, By GOLD Stage: TONADO | S. Korn | Poster #P520 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
High Level Of Agreement Between Home-Based And In-Clinic Spirometry Results In The WISDOM COPD Study | H. Magnussen | Poster #P576 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Predictors Of Response To Treatment From Two Randomized, Double-Blind, Active-Controlled Studies Combining Olodaterol Respimat® And Tiotropium HandiHaler® In Patients With COPD | R. Abrahams | Poster #P511 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Safety Of Combining Olodaterol Respimat® And Tiotropium HandiHaler® In African-American Patients With COPD: Results Of Pooled Data From Two Randomized, Double-Blind, Active-Controlled Studies | R. Abrahams | Poster #P534 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
The Influence Of Log Transformation In Analyzing Exercise Endurance Time Data In COPD: Results From Two Olodaterol Trials | F. Maltais | Poster #P504 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Development Of A Deterministic Patient-Level Markov Model Of Bronchodilator Maintenance Treatment In Chronic Obstructive Pulmonary Disease | C. Selya-Hammer | Poster #211 Date: Wednesday, May 20, 2015 Session Time: 1:30pm 3:30pm MT |
Tiotropium Safety and Performance In Respimat® (TIOSPIR): Safety And efficacy In Patients With Tiotropium HandiHaler® Use At Baseline | P. Calverley | Poster #P513 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Effect Of The Lower Limit Of Normal Classification Of Patients On Results From The TIOSPIR Trial | P. Calverley | Poster #P1105 Date: Tuesday, May 19, 2015 Session Time: 9:30am 4:15pm MT |
Cardiac Safety Of Tiotropium In Patients With Cardiac Events: A Retrospective, Combined Analysis Of The UPLIFT® And TIOSPIR Trials | D. Tashkin | Poster #P537 Date: Wednesday, May 20, 2015 Session Time: 9:30am 3:30pm MT |
Asthma Presentations
Phase III data from the UniTinA-asthma® program of investigational tiotropium RESPIMAT will also be presented at ATS; specifically data from the PrimoTinA-, MezzoTinA-, and GraziaTinA-asthma® trials in adult patients with severe, moderate and mild symptomatic asthma. Tiotropium RESPIMAT is being studied as a once daily, add-on treatment in asthma patients who continue to experience symptoms (e.g., wheezing, shortness of breath, chest tightness and cough) despite the use of maintenance therapy, including inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA). Tiotropium RESPIMAT is being investigated to determine its efficacy and safety in treating asthma patients and is not currently approved in the U.S. for this indication.
Title | Lead / Presenting Author | Presentation Details |
Once-daily Tiotropium Respimat® Add-on Therapy Improves Symptom Control Across Severities Of Symptomatic Asthma, Independent Of Allergic Status | J.M. FitzGerald | Poster #P290 Date: Tuesday, May 19, 2015 Session Time: 9:30am 4:15pm MT |
Tiotropium Respimat® Add-on Therapy Improves Lung Function, As Measured By Peak Expiratory Flow, In Adult Patients Across Severities Of Symptomatic Asthma | D.E. Doherty | Poster #P285 Date: Tuesday, May 19, 2015 Session Time: 9:30am 4:15pm MT |
Tiotropium Respimat® Add-on Therapy Reduces Exacerbation Risk In Patients With Symptomatic Moderate To Severe Asthma, Independent Of T Helper 2 Inflammatory Status | T.B. Casale | Poster #P209 Date: Tuesday, May 19, 2015 Session Time: 9:30am 4:15pm MT |
Idiopathic Pulmonary Fibrosis (IPF) Presentations
Boehringer Ingelheim is presenting new analyses from clinical trials of OFEV capsules including pooled subgroup analyses of Phase III trials, safety data beyond 52 weeks from the Phase III INPULSIS® trials, and safety and efficacy data through 76 weeks from the Phase II TOMORROW® trial.
Title | Lead / Presenting Author | Presentation Details |
Safety And Tolerability Of Nintedanib In Patients With IPF: Interim Analysis From An Open-Label Extension Of The INPULSIS® trials (INPULSIS®-ON) | B. Crestani | Oral Presentation #A15 Date: Sunday, May 17, 2015 Session Time: 9:30am - 11:30am MT |
Consistent Effect Of Nintedanib On Decline In FVC In Patients Across Subgroups Based On HRCT Diagnostic Criteria: Results From The INPULSIS® Trials In IPF | G. Raghu | Oral Presentation #A15 Date: Sunday, May 17, 2015 Session Time: 9:30am - 11:30am MT |
Effect Of Baseline FVC On Decline In Lung Function With Nintedanib In Patients With IPF: Results From The INPULSIS® Trials | M. Kolb | Oral Presentation #A15 Date: Sunday, May 17, 2015 Session Time: 9:30am - 11:30am MT |
Efficacy And Safety Of Nintedanib In Patients With IPF Beyond Week 52: Data From The Phase II TOMORROW Trial | L. Richeldi | Oral Presentation #A15 Date: Sunday, May 17, 2015 Session Time: 9:30am - 11:30am MT |
The Effect Of Nintedanib Compared To Pirfenidone On Serum-Stimulated Proliferation Of Human Primary Lung Fibroblasts At Clinically Relevant Concentrations | J. Schuett | Poster #P370 Date: Tuesday, May 19, 2015 Session Time: 9:30am 4:15pm MT |
Effects Of Nintedanib On The Microvascular Architecture In A Bleomycin-Induced Pulmonary Fibrosis Model | M. Ackermann | Poster #P31 Date: Tuesday, May 19, 2015 Session Time: 9:30am 4:15pm MT |
Vasorelaxant Properties Of Nintedanib In The Murine Pulmonary Circulation | A. Rieg | Poster #P504 Date: Sunday, May 17, 2015 Session Time: 9:30am 4:15pm MT |
About Spiriva® HandiHaler® (tiotropium bromide inhalation powder) and SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray
INDICATION
SPIRIVA HandiHaler and SPIRIVA RESPIMAT are indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.
IMPORTANT SAFETY INFORMATION
SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any component of either product.
SPIRIVA is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.
Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. Additionally, inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA should be stopped and other treatments considered.
Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to SPIRIVA.
SPIRIVA HandiHaler should be used with caution in patients with severe hypersensitivity to milk proteins.
SPIRIVA should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction occur.
Since dizziness and blurred vision may occur with the use of SPIRIVA, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.
Patients with moderate to severe renal impairment (creatinine clearance of </= 50 mL/min for SPIRIVA HandiHaler) and (creatinine clearance of < 60 mL/min for SPIRIVA RESPIMAT) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.
SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.
The most common adverse reactions >5% incidence and exceeded placebo by >/=1% with SPIRIVA HandiHaler (placebo) were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction >/=3% incidence and higher than placebo from the 4-year trial with SPIRIVA HandiHaler (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).
The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).
SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device and the HandiHaler device should not be used for administering other medications.
Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.
Please click for full Prescribing Information for SPIRIVA HandiHaler and for SPIRIVA RESPIMAT.
For full prescribing information, please visit www.SPIRIVA.com, or call 1-800-542-6257 option #4.
About OFEV® (nintedanib) capsules
Indication and Usage
OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Elevated Liver Enzymes
- The safety and efficacy of OFEV has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Treatment with OFEV is not recommended in patients with moderate or severe hepatic impairment.
- In clinical trials, administration of OFEV was associated with elevations of liver enzymes (ALT, AST, ALKP, and GGT) and bilirubin. Liver enzyme increases were reversible with dose modification or interruption and not associated with clinical signs or symptoms of liver injury. The majority (94%) of patients with ALT and/or AST elevations had elevations <5 times ULN. The majority (95%) of patients with bilirubin elevations had elevations <2 times ULN.
- Conduct liver function tests (ALT, AST, and bilirubin) prior to treatment with OFEV, monthly for 3 months, and every 3 months thereafter, and as clinically indicated. Dosage modifications, interruption, or discontinuation may be necessary for liver enzyme elevations.
Gastrointestinal Disorders
Diarrhea
- Diarrhea was the most frequent gastrointestinal event reported in 62% versus 18% of patients treated with OFEV and placebo, respectively. In most patients, the event was of mild to moderate intensity and occurred within the first 3 months of treatment. Diarrhea led to permanent dose reduction in 11% of patients treated with OFEV compared to 0 placebo-treated patients. Diarrhea led to discontinuation of OFEV in 5% of the patients compared to <1% of placebo-treated patients.
- Dosage modifications or treatment interruptions may be necessary in patients with adverse reactions of diarrhea. Treat diarrhea at first signs with adequate hydration and antidiarrheal medication (e.g., loperamide), and consider treatment interruption if diarrhea continues. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If severe diarrhea persists despite symptomatic treatment, discontinue treatment with OFEV.
Nausea and Vomiting
- Nausea was reported in 24% versus 7% and vomiting was reported in 12% versus 3% of patients treated with OFEV and placebo, respectively. In most patients, these events were of mild to moderate intensity. Nausea led to discontinuation of OFEV in 2% of patients. Vomiting led to discontinuation of OFEV in 1% of the patients.
- For nausea or vomiting that persists despite appropriate supportive care including anti-emetic therapy, dose reduction or treatment interruption may be required. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If severe nausea or vomiting does not resolve, discontinue treatment with OFEV.
Embryofetal Toxicity
OFEV is Pregnancy category D. It can cause fetal harm when administered to a pregnant woman.
To read full press release, please click here.
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