Respimat® delivers drug actively without the need of COPD patients to forcefully inhale

Document ID: PC-SG-100252

01/04/2019

Author: Boehringer Ingelheim


Dry powder inhalers are breath actuated and require forceful inhalation to release the active drug from carrier particles1,4,5. More than 50% patients have sub-optimal PIFR and cannot forcefully inhale leading to a paradoxical situation.2-12

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References

1. Pitcairn G et al. J Aerosol Med 2005;3:264-272.
2. Anderson A. Int J Chron Obstruct Pulmon Dis 2006;1:251-259.
3. Dalby R et al. Med Devices: Evidence and Research 2011;4:145-155.
4. Ghosh S, Ohar JA, Drummond MB. Peak inspiratory flow rate in chronic obstructive pulmonary disease: implications for dry powder inhalers. J Aerosol Med Pulm Drug Deliv. 2017;30(5):381-387
5. Loh CH, Peters SP, Lovings TM, Ohar JA. Suboptimal inspiratory flow rates are associated with chronic obstructive pulmonary disease and all-cause readmissions. Ann Am Thorac Soc. 2017;14(8):1305-1311.
6. Yang J, Wu C-Y, Adams M. Three-dimensional DEM-CFD analysis of air-flow-induced detachment of API particles from carrier particles in dry powder inhalers. Acta Pharmaceutica Sinica B. 2014;4(1):52-59
7. Telko M J, Hickey A J. Dry powder inhaler formulation. Respir Care. 2005;50(9):1209-1227.
8. Jarvis S, Ind PW, Shiner JR. Inhaled therapy in elderly COPD patients; time for re-evaluation? Age Ageing. 2007;36(2):213-218.
9. Wachtel H, Kattenbeck S, Dunne S, Disse B. The Respimat® development story: patient-centered innovation. Pulm Ther. 2017;3(1):1-12
10. Dalby RN, Eicher J, Zierenberg B. Development of Respimat® Soft MistTM Inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl). 2011;4:145-155.
11. SPIRIVA® RESPIMAT® [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2018.
12. 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.
13. Dalby R, et al. A review of the development of Respimat® Soft Mist Inhaler. Int J Pharm 2004; 283:1-9.
14. Janssens W at al. Inspiratory Flow rates at different levels of resistance in elderly CORD patients.
15. Sharma G. et al. Prevalence of low peak inspiratory flow rate at discharge in patients hospitalized for COPD exacerbation. Chronic Obstr Pulm Dis 2017;4:217-224.

PC-SG-100210
Production date: Apr 2019

What is Spiolto® Respimat® (tiotropium/olodaterol)?

Tiotropium/olodaterol is approved as once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. It is built on tiotropium, the active ingredient in Spiriva® and is enhanced by olodaterol which was specifically designed to complement the efficacy of tiotropium. Tiotropium/olodaterol provides significant improvements in lung function, COPD symptoms and quality of life over tiotropium – right from the initial stages when suitable patients need maintenance therapy.[1-4]

Tiotropium/olodaterol is administered via Respimat®, the only inhaler available that actively delivers a unique mist. This means the patient just needs to take a slow deep breath to get the medication deep into the lungs.*[5-9]
 

What is the safety profile of Spiolto® Respimat® (tiotropium/olodaterol)?

Spiolto® Respimat® (tiotropium/olodaterol) has a comparable adverse event profile to the component monotherapies.[10]

Adverse event incidence was generally balanced across all treatment groups, with the majority being mild to moderate in severity.[10]

Spiolto® Respimat® safety and tolerability profile was established in patients treated for up to 52 weeks.[10]

The proportion of patients who discontinued due to adverse events with Spiolto® Respimat® was comparable to that of Spiriva® (tiotropium) and Striverdi® (olodaterol).[10]

The percentage of patients reporting an adverse event with Spiolto® Respimat® was comparable to that of Spiriva®.[10]

For full safety profile, please refer to the Local Prescribing Information.

What are the contraindications of Spiolto® Respimat® (tiotropium/olodaterol)?[4]

Spiolto® Respimat® is contraindicated in patients with hypersensitivity to tiotropium or olodaterol or to any of the excipients.

Spiolto® Respimat® is also contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium.

For information on warnings and precautions, please refer to the Local Prescribing Information.
 
References

[1] Maltais F et al. Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD. Thorax 2014;69:A186-A187

[2] Ferguson F et al. Efficacy of tiotropium+olodaterol in patients with COPD by initial disease severity and treatment intensity: a post hoc analysis. Adv Ther. 2015; 32(6): 523-526

[3] Singh D et al. Tiotropium+olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015; 10: 1312-1319

[4] Spiolto® Respimat® Summary of Product Characteristics, February 2017

[5] Newman SP et al. 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

[6] Pitcairn G et al. 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

[7] Dalby R et al. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004; 283: 1-9

[8] Dalby RN et al. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155

[9] Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis 2006; 1(3): 251–259

[10] Buhl R, et al. Eur Respir J. 2015;45:969-979.

[11] Spiriva® Respimat® Summary of Product Characteristics January 2017.

[12] Striverdi® Respimat® Summary of Product Characteristics March 2016.