Spiolto Respimat in COPD

Spiolto® Respimat® (tiotropium/olodaterol) is Boehringer Ingelheim’s new advance in COPD maintenance therapy.

Spiolto® Respimat® (tiotropium/olodaterol) is Boehringer Ingelheim’s new advance in COPD maintenance therapy.

Spiolto® Respimat® provides significant improvements in lung function, breathlessness, quality of life and reduction of rescue medication use over Spiriva® Respimat®; right from the initial stages when patients need maintenance therapy.1

Spiolto® is administered via Respimat®, which actively** delivers a unique mist, meaning the patient just needs to take a slow deep breath.2-8

Built on tiotropium, the active ingredient in Spiriva® HandiHaler® and Spiriva® Respimat® - the world’s most prescribed COPD maintenance treatment with over 40 million patient-years* of real life experience across all COPD severities

Enhanced by Striverdi® (olodaterol) which was specifically designed to complement the efficacy of Spiriva®
 

The clinical course of COPD and the TOviTO® clinical trial programme

In COPD, decreasing lung function causes breathlessness and leads to a downward spiral of reduced physical activity, worsening symptoms and further inactivity.9 Decreasing exercise capacity reduces quality of life and increases the risk of disability and death.10

The >15,000 patient TOviTO® Phase III clinical trial programme has been designed to evaluate the effect of Spiolto® Respimat® on many of these important elements in the clinical course of COPD.
 

 

Efficacy and safety results from TONADO® 1&2: the pivotal Phase III trials for Spiolto® Respimat®

Data from the pivotal Phase III TONADO® trials show Spiolto® Respimat® provides1*… The importance of immediate COPD management

The importance of immediate COPD management

Further data from TONADO®1&2

A post-hoc analysis shows that Spiolto® Respimat® more than doubles the improvement in lung function§ compared to Spiriva® Respimat® in patients who had no prior long-acting bronchodilator (LABD) at baseline13 ¶

Footnotes

‡ Figure adapted from Tantucci C, Modina D. Int J Chron Obstruct Pulmon Dis 2012 § Improvement in trough FEV1 after 24 weeks of treatment ¶ Results are derived from a post-hoc subgroup analysis of patients by GOLD stages in the TONADO® 1&2 studies (combined dataset). The primary endpoints of the TONADO® studies were: FEV1 AUC0–3, trough FEV1 and SGRQ total score in patients with a history of moderate-to-very severe COPD (GOLD 2–GOLD 4).

Referências

  1. Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD2-4). Eur Respir J 2015; 45(4):969-79.
  2. Newman SP, Brown J, Steed KP, Reader SJ, Kladders H. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: Comparison of Respimat® with conventional metered-dose inhalers with and without spacer devices. Chest 1998; 113: 957-963.
  3. Pitcairn G, Reader S, Pavia D, Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med 2005; 18(3): 264-272.
  4. Peterson JB, Prisk GK, Darquenne C. Aerosol deposition in the human lung periphery is increased by reduced-density gas breathing. J Aerosol Med Pulm Drug Deliv. 2008; 21(2): 159–168.
  5. Dalby R, Spallek M, Voshaar T. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004; 283: 1-9.
  6. Zierenberg B. Optimising the in vitro performance of the Respimat®. J Aerosol Med 1999; 12 (Suppl 1): S19-S24.
  7. Dalby RN, Eicher J, Zierenberg B. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155.
  8. Anderson P. Use of Respimat® Soft Mist™ Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006:1(3) 251–259.
  9. Reardon JZ, Lareau SC, ZuWallack R. Functional status and quality of life in chronic obstructive pulmonary disease. Am J Med 2006; 119 (10 Suppl 1): 32-7.
  10. Casaburi R. Activity promotion: a paradigm shift for chronic obstructive pulmonary disease therapeutics. Am Thorac Soc 2011; 8(4):334-7.
  11. Mapel DW, et al. Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims. Int J COPD 2011:6 573–581
  12. Tantucci C, Modina D. Lung function decline in COPD. Int J Chron Obstruct Pulmon Dis 2012; 7:95-9.
  13. Buhl R, Abrahams R, Grönke L, et al. 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 Two 1-Year Studies. ATS 2015 congress Abstract 64799
  14. Korn S, Buhl R, Grönke L, et al. Analysis of the Efficacy and Safety of the Fixed-Dose Combination of Tiotropium + Olodaterol in Patients with COPD by Initial Disease Severity. ATS 2015 congress Abstract 64575 ERS 2015 abstract information: 1. D. Singh, Tiotropium + olodaterol fixed-dose combination shows clinically meaningful improvements in quality of life versus placebo. Poster PA2958 presented at the European Respiratory Society International Congress, Amsterdam, Monday, 28 September 2015, 14:45-16:45. 2. K.M. Beeh, ENERGITO: efficacy and safety of once-daily combined tiotropium + olodaterol versus twice-daily combined fluticasone propionate + salmeterol. Poster PA4366 presented at the European Respiratory Society International Congress, Amsterdam, Tuesday, 29 September 2015; 12:50-14:40