Treatment Goals

Treatment Goal 1: Lung Function (FEV1)

You can reach twice the improvement in lung function with STIOLTO RESPIMAT vs SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray1*

Significant improvement in patient lung function vs SPIRIVA RESPIMAT1*

 FEV1 Lung Function Improvement, Stiolto and Spiriva
 

Select results in patients with GOLD 2-4 (TONADO 1). Similar results confirmed in a replicate trial (TONADO 2).

Co-primary endpoints at 24 weeks in patients with GOLD 2–4: in TONADO 1, 71-mL improvement in trough FEV1 response vs SPIRIVA RESPIMAT (P≤0.0001), and an 82-mL improvement vs STRIVERDI RESPIMAT (olodaterol) Inhalation Spray (P≤0.0001). 117-mL improvement in FEV1 AUC 0-3h vs SPIRIVA RESPIMAT (P≤0.0001) and a 123-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001). In TONADO 2, trough FEV1 50-mL improvement vs SPIRIVA RESPIMAT (P≤0.0001); 88-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001), FEV1 AUC 0-3h 103-mL improvement vs SPIRIVA RESPIMAT (P≤0.0001); 132-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001).1,2

Patients on STIOLTO achieved superior improvement in lung function compared with SPIRIVA RESPIMAT1,3

TONADO Clinical Trials, FEV1 Response Improvement ChartTONADO Clinical Trials, FEV1 Response Improvement Chart

  • TONADO 1: Significant 117-mL increase in FEV1 AUC0-3h vs SPIRIVA RESPIMAT (P≤0.0001) and 123-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001)1,2
  • TONADO 2: Significant 103-mL improvement in FEV1 AUC0-3h vs SPIRIVA RESPIMAT (P≤0.0001) and 132-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001)1,2

AUC0-3h = area under the curve from 0-3 h.

The increased bronchodilator effects of STIOLTO compared with tiotropium 5 mcg and olodaterol 5 mcg were maintained throughout the 52-week treatment period.1

*Select results in patients with GOLD 2–4 (TONADO 1). Similar results confirmed in a replicate trial (TONADO 2). Co-primary endpoints at 24 weeks in patients with GOLD 2–4: in TONADO 1, 71-mL improvement in trough FEV1 response vs SPIRIVA RESPIMAT (P≤0.0001), and an 82-mL improvement vs STRIVERDI RESPIMAT (olodaterol) Inhalation Spray (P≤0.0001). 117-mL improvement in FEV1 AUC0-3h vs SPIRIVA RESPIMAT (P≤0.0001) and a 123-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001). In TONADO 2, trough FEV1 50-mL improvement vs SPIRIVA RESPIMAT (P≤0.0001); 88-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001 ), FEV1 AUC0-3h 103-mL improvement vs SPIRIVA RESPIMAT (P≤0.0001); 132-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001).1,2

STIOLTO starts working in 5 minutes and lasts a full 24 hours1,4

STIOLTO starts working within 5 minutes of the first dose and improves lung function for 24 hours.1

STIOLTO is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

COPD Symptom Management, 24-hour duration

Increases in lung function were observed within 5 minutes of first dosing with STIOLTO1

STIOLTO RESPIMAT helps patients reach therapeutic levels and stay there for 24 hours.

STIOLTO is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

STIOLTO may help the majority of your COPD patients1

STIOLTO can be used as an upgrade for patients on SPIRIVA who have persistent symptoms, when lung function (FEV1) and health-related quality of life matter most.1,3

Patients with stages 2-4 COPD may5,6

  • Experience loss of lung function over time
  • Often report COPD-related issues and challenges, including diminished health-related quality of life
  • Overuse rescue medication

Reduce the need for rescue medication with STIOLTO vs SPIRIVA RESPIMAT

Daytime and nighttime rescue medication use was lower for patients on STIOLTO vs SPIRIVA RESPIMAT.1

Rescue medication use was reduced at 52 weeks.1

  • Less need for rescue medication in both daytime and nighttime1

Median daytime puffs per day at 52 weeks:
STIOLTO® RESPIMAT® vs SPIRIVA® RESPIMAT® (Trial 1)1

COPD Rescue Medication Reduction in Daytime, Stiolto and SpirivaCOPD Rescue Medication Reduction in Daytime, Stiolto and Spiriva

Median nighttime puffs per day at 52 weeks:
STIOLTO® RESPIMAT® vs SPIRIVA® RESPIMAT® (Trial 1)1

COPD Rescue Medication Reduction in Nighttime, Stiolto and SpirivaCOPD Rescue Medication Reduction in Nighttime, Stiolto and Spiriva

Weekly mean daily rescue medication use was shown to be lower over the course of 52 weeks with STIOLTO vs tiotropium or olodaterol alone.4

Lung function declines most rapidly earlier in the course of COPD7,8

LAMA/LABA Dual Therapy Efficacy for GOLD 2 COPDLAMA/LABA Dual Therapy Efficacy for GOLD 2 COPD

 

Although no therapy has been shown to reduce the annual rate of decline in FEV1 in patients with COPD, it is important to consider treatment options to improve lung function.

As a LAMA/LABA, STIOLTO can effectively help improve lung function (FEV1) in many of your patients.1

Clinical data have demonstrated that STIOLTO provided significant improvements in lung function (FEV1) over SPIRIVA RESPIMAT.

ICS-containing regimens are NOT recommended as initial maintenance treatment for COPD of any severity.5

STIOLTO can make a significant improvement in FEV1 across a range of disease severities1

Greater lung function improvement across a range of disease severities using STIOLTO vs SPIRIVA RESPIMAT1,4

Efficacy of Stiolto and Spiriva for Treating GOLD 2 COPDEfficacy of Stiolto and Spiriva for Treating GOLD 2 COPD

  • Trough FEV1 response at 24 weeks in a prespecified pooled subgroup analysis1,4

STIOLTO effectively combines two long-acting COPD medicines that work in two different ways—tiotropium and olodaterol. Both of these medications have a similar adverse event profile.1,3

Remember, STIOLTO can double the improvement in lung function (FEV1) vs SPIRIVA RESPIMAT for many of your patients.1*

Based on results in patients with GOLD 2-4 (TONADO 1). Similar results confirmed in a replicate trial (TONADO 2).

Tiotropium and Olodaterol as a Dual Treatment for COPD

*Co-primary endpoints at 24 weeks in patients with GOLD 2–4: in TONADO 1, 71-mL improvement in trough FEV1 response vs SPIRIVA RESPIMAT (P≤0.0001), and an 82-mL improvement vs STRIVERDI RESPIMAT (olodaterol) Inhalation Spray (P≤0.0001). 117-mL improvement in FEV1 AUC0-3h vs SPIRIVA RESPIMAT (P≤0.0001) and a 123-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001). In TONADO 2, trough FEV1 50-mL improvement vs SPIRIVA RESPIMAT (P≤0.0001); 88-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001), FEV1 AUC0-3h 103-mL improvement vs SPIRIVA RESPIMAT (P≤0.0001); 132-mL improvement vs STRIVERDI RESPIMAT (P≤0.0001).1,2

STIOLTO is an option for any COPD patients.4 It can also be used as an upgrade for patients on SPIRIVA who have persistent symptoms, when lung function (FEV1) and health-related quality of life matter most.1,3

Patients with stages 2-4 COPD may5,6

  • Experience loss of lung function over time
  • Often report COPD-related issues and challenges, including diminished health-related quality of life
  • Overuse rescue medication

References: 1. STIOLTO RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2016. 2. Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2–4). Eur Respir J. 2005;45(4): 869–871. 3. SPIRIVA RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2016. 4. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. 5. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/. Updated January 2017. Accessed February 22, 2017. 6. Chronic obstructive pulmonary disease – quick-relief drugs. National Institutes of Health Medline Plus Web site. https://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000026.htm. Updated February 2, 2016. Accessed January 26, 2017. 7. Tantucci C, Modina D. Lung function decline in COPD. Int J COPD. 2012;7:95–99. 8. Vestbo J, Edwards LD, Scanlon PD, Yates JC. Changes in forced expiratory volume in 1 second over time in COPD. NEJM. 2011;365(13):1184–1192.

Improved Lung Function (FEV1), COPD Patient

Treatment Goal 2: Health-Related Quality of Life1,2

More activity, engagement, and time without symptoms1,2

Significantly improve health-related quality of life (HRQoL) for more patients with STIOLTO RESPIMAT vs SPIRIVA RESPIMAT as measured by the St. George's Respiratory Questionnaire (SGRQ).1,2

Compared to SPIRIVA RESPIMAT, the once-daily dose of STIOLTO allows more patients to feel the difference in their lives, including1,2

  • more time without symptoms
  • more activity
  • more engagement
COPD Health-Related Quality of Life (HQoL) ImprovementCOPD Health-Related Quality of Life (HQoL) Improvement 

Clinically meaningful improvements in health-related quality of life (HRQoL) with STIOLTO vs placebo and SPIRIVA RESPIMAT vs placebo1,3

  • Among patients in this study achieving these improvements, 53% did not use an ICS for maintenance (and 90% did not use xanthines)1

COPD St. George's Respiratory Questionnaire (SGRQ) Total Score ImprovementCOPD St. George's Respiratory Questionnaire (SGRQ) Total Score Improvement

STIOLTO demonstrated a clinically meaningful change (≥4 units) in health-related quality of life (HRQoL) in 2 studies as measured by improvement from baseline in mean St George’s Respiratory Questionnaire (SGRQ) total score2,3

  • 4.89-unit difference vs 2.40 for SPIRIVA RESPIMAT in OTEMTO 1
  • 4.56-unit difference vs 2.85 for SPIRIVA RESPIMAT in OTEMTO 2

Clinically meaningful improvement in the majority of patients with STIOLTO3,4

  • In OTEMTO 1, SGRQ responder rates at week 12 (defined as an improvement in score of 4 or more as a threshold) were 53%, 42%, and 31% for STIOLTO, SPIRIVA, and placebo, respectively; results were similar in OTEMTO 2

*Two replicate, multinational, double-blind, parallel-group, placebo-controlled studies (OTEMTO 1 and 2) evaluated the effect of STIOLTO RESPIMAT on health-related quality of life and lung function. Patients were randomized to three treatment arms: STIOLTO RESPIMAT, SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray, placebo.3

Reduced the need for rescue medication with STIOLTO vs SPIRIVA RESPIMAT5

Over the course of 52 weeks, the weekly mean daily rescue medication use was shown to be lower with STIOLTO vs tiotropium or olodaterol alone.5

  • This study endpoint is descriptive in nature.

Rescue medication use throughout the 52-week trial (Trial 1)5

COPD Rescue Medication Reduction, Stiolto and Spiriva

COPD Rescue Medication Reduction, Stiolto and Spiriva

References: 1. STIOLTO RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2016. 2. Jones PW, Forde Y. St George’s Respiratory Questionnaire Manual. London, UK: St George’s, University of London; 2009. 3. Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015;109(10):1312–1319. 4. Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19:398–404. 5. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

Treatment Goal 3: Improved Delivery

Deliver the medicine deep into the patients’ lungs with STIOLTO RESPIMAT 1-3

STIOLTO is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

STIOLTO RESPIMAT is engineered specifically for patients who need inhaled therapy. It starts working in 5 minutes and lasts a full 24 hours1,4,5.

RESPIMAT can help your patients with:

  • Lung deposition: The mist is composed of highly respirable, small particle-sized droplets1
  • Inhalation effort: RESPIMAT inhaler delivers medicine independent of inspiratory effort and helps get medication deep into patients’ lungs
  • Coordination: RESPIMAT inhaler may help facilitate actuation and inhalation

As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds).

Improved Delivery and Slow-Moving Mist, STIOLTO RESPIMAT

Consider once-daily STIOLTO to help your COPD patients reach key treatment goals.

References: 1. Brand P, Hederer B, Austen G, Dewberry H, Meyer T. Higher lung deposition with Respimat Soft Mist Inhaler than HFA MDI in COPD patients with poor technique. Int J COPD. 2008;3(4):763–770. 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(4):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. Dalby RN, Eicher J, Zierenberg B. Development of Respimat Soft Mist Inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl). 2011;4:145–155. 5. STIOLTO RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2016.

 

Efficacy, COPD Patient