New Data Analyses on Investigational Tiotropium/Olodaterol Respimat® Showed Greater Lung Function Improvement Compared to Tiotropium and Olodaterol Alone
New data analyses further examine efficacy and safety across all GOLD categories, as well as COPD patients beginning or already on a maintenance therapy, including inhaled corticosteroids (ICS)
DENVER, May 20, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced new data analyses from the pivotal Phase III TONADO™ 1&2 studies (NCT01431274/NCT01431287), which explored the efficacy and safety of investigational tiotropium/olodaterol delivered via the Respimat® inhaler for chronic obstructive pulmonary disease (COPD) compared to the individual components (tiotropium and olodaterol delivered by the RESPIMAT inhaler) alone. These data analyses were presented today at the American Thoracic Society (ATS) 2015 International Conference in Denver.
“Because lung function can be substantially reduced by the time most COPD patients first see a physician, maintenance treatment should be considered at the time of diagnosis,” said Gary T. Ferguson, MD, Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan, and study investigator. “In these analyses, we saw that tiotropium/olodaterol RESPIMAT demonstrated a statistically significant improvement in lung function compared to tiotropium and olodaterol alone for COPD patients across all stages of the disease (A-D).”
The analyses presented at ATS showed:
- After 24 weeks of treatment, tiotropium/olodaterol RESPIMAT 5/5 μg improved lung function, as measured by trough FEV1, compared to tiotropium RESPIMAT 5 μg in patients who were untreated and previously treated with maintenance bronchodilator therapy (mean increase 76 mL and mean increase 48 mL, respectively)
- Tiotropium/olodaterol RESPIMAT 5/5 μg provided statistically significant improvements in lung function, as measured by trough FEV1 and FEV1AUC0-3, compared to tiotropium RESPIMAT 5 μg and olodaterol RESPIMAT 5 μg alone in patients across all COPD stages
- Tiotropium/olodaterol RESPIMAT 5/5 μg demonstrated statistically significant improvement of lung function over tiotropium RESPIMAT 5 μg and olodaterol RESPIMAT 5 μg irrespective of whether patients were taking inhaled corticosteroids (ICS) at the start of the trials
- Tiotropium/olodaterol RESPIMAT 5/5 μg had a comparable safety profile to tiotropium RESPIMAT 5 μg or olodaterol RESPIMAT 5 μg alone
TONADO™ 1&2 were 52-week, double-blind, parallel-group studies in which patients with moderate to very severe COPD were randomized to receive olodaterol 5 μg, tiotropium 2.5 μg, tiotropium 5 μg, tiotropium/olodaterol 2.5/5 μg or tiotropium/olodaterol 5/5 μg, all delivered via the RESPIMAT inhaler. These studies are part of a large Phase III clinical trial program (TOviTO®) for tiotropium/olodaterol RESPIMAT, which includes more than 15,000 people with varying severities of COPD worldwide.
Tiotropium/olodaterol is administered via RESPIMAT, the platform inhaler for the Boehringer Ingelheim respiratory therapies, including approved and investigational therapies. RESPIMAT is the only inhaler that actively delivers a slow-moving mist that helps patients inhale the medication. It also delivers medication independent of inspiratory effort*, or how much air a person can breathe into their lungs.
“Boehringer Ingelheim has had an unwavering commitment to the COPD community in the U.S. for more than 40 years,” said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “We’re encouraged by these new data from the pivotal tiotropium/olodaterol RESPIMAT trials, and are working with regulatory authorities to bring this treatment to patients and their healthcare providers soon.”
Abstracts Presented at ATS
Tiotropium Plus 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 [Abstract 64799]
- Analysis of the Efficacy and Safety of the Fixed-Dose Combination of Tiotropium + Olodaterol in Patients with COPD by Initial Disease Severity [Abstract 64575]
- Analysis of the Efficacy and Safety of the Fixed-Dose Combination of Tiotropium + Olodaterol in Patients with COPD by Previous Usage of Inhaled Corticosteroids [Abstract 64646]
- Pooled Safety Analysis of Adjudicated Serious Adverse Events with the Fixed-Dose Combination of Tiotropium + Olodaterol [Abstract 64788]
Additional Information on the Data Presented at ATS
Analysis of the Efficacy and Safety of the Fixed-Dose Combination of Tiotropium + Olodaterol in Patients with COPD by Initial Disease Severity [Abstract 64575]
| Trough FEV1, L Adjusted mean (SE) change |
FEV1AUC0-3, L Adjusted mean (SE) change |
|
|---|---|---|
| GOLD 2 | ||
| T/O 5/5 μg | 0.151 (0.010) | 0.296 (0.009) |
| T 5 μg | 0.083 (0.009) | 0.177 (0.009) |
| O 5 μg | 0.068 (0.009) | 0.164 (0.009) |
| GOLD 3 | ||
| T/O 5/5 μg | 0.142 (0.009) | 0.247 (0.009) |
| T 5 μg | 0.083 (0.010) | 0.135 (0.010) |
| O 5 μg | 0.054 (0.010) | 0.120 (0.010) |
| GOLD 4 | ||
| T/O 5/5 μg | 0.081 (0.012) | 0.157 (0.012) |
| T 5 μg | 0.061 (0.011) | 0.095 (0.012) |
| O 5 μg | 0.012 (0.012) | 0.052 (0.012) |
Analysis of the Efficacy and Safety of the Fixed-Dose Combination of Tiotropium + Olodaterol in Patients with COPD by Previous Usage of Inhaled Corticosteroids [Abstract 64646]
| Trough FEV1, L Adjusted mean (SE) change |
FEV1AUC0-3, L Adjusted mean (SE) change |
|||
|---|---|---|---|---|
| ICS Usage | No ICS Usage |
ICS Usage | No ICS Usage |
|
| T/O 5/5 μg | 0.133 (0.009) | 0.149 (0.009) | 0.260 (0.008) |
0.263 (0.009) |
| T 5 μg | 0.088 (0.009) | 0.073 (0.009) | 0.147 (0.009) |
0.155 (0.008) |
| O 5 μg | 0.046 (0.009) | 0.067 (0.009) | 0.129 (0.009) |
0.139 (0.009) |
Pooled Safety Analysis of Adjudicated Serious Adverse Events with the Fixed-Dose Combination of Tiotropium + Olodaterol [Abstract 64788]
| T/O 5/5 μg n (%) |
T 5 μg n (%) |
O 5 μg n (%) |
|
| Total # of patients | 1029 | 1033 | 1038 |
| Any adjudicated SAEs | 161 (15.6) | 162 (15.7) | 171 (16.5) |
| Any respiratory-related SAEs | 91 (8.8) | 84 (8.1) | 85 (8.2) |
| Key respiratory-related SAEs | 83 (8.1) | 70 (6.8) | 78 (7.5) |
| COPD-related SAEs | 71 (6.9) | 65 (6.3) | 67 (6.5) |
| Pneumonia-related SAEs | 18 (1.7) | 9 (0.9) | 15 (1.4) |
| Other respiratory-related SAEs | 11 (1.1) | 17 (1.6) | 7 (0.7) |
| Cardio vascular-related SAEs | 19 (1.8) | 19 (1.8) | 15 (1.4) |
| Any cerebrovascular SAEs | 5 (0.5) | 5 (0.5) | 6 (0.6) |
| Stroke-related SAEs | 2 (0.2) | 5 (0.5) | 3 (0.3) |
| Other cerebrovascular-related SAEs | 3 (0.3) | 0 | 4 (0.4) |
| Non-respiratory, non-CV, non-cerebrovascular- related SAEs |
71 (6.9) | 74 (7.2) | 78 (7.5) |
About COPD
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.
The most common symptom of COPD is shortness of breath. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.
Leading Respiratory Forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. 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 help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
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Footnotes
*As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration should be at least as long as the spray duration (1.5 seconds).