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SPIRIVA RESPIMAT 2.5mcg is the only LAMA indicated to reduce exacerbations1

In a 1-year, randomized, double-blind, parallel-group study, SPIRIVA RESPIMAT reduced the risk of COPD exacerbations by 31%.2

Graph showing that SPIRIVA RESPIMAT reduced the risk of exacerbations by 31% when compared to a placebo

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SPIRIVA RESPIMAT reduces the risk of exacerbation-related hospitalizations1,2

SPIRIVA RESPIMAT significantly reduced the risk of exacerbation-related hospitalizations by 27%.2

Graph showing that SPIRIVA RESPIMAT significantly reduced the risk of exacerbation related hospitalizations by 27% when compared to a placebo

STUDY DESIGN

In a 1-year, randomized, double-blind, parallel-group study, 3991 patients with COPD were evaluated to compare SPIRIVA RESPIMAT and placebo on coprimary endpoints: change in trough FEV1 from treatment Day 1 to Day 337 and time to first COPD exacerbation. Secondary endpoints were changes in trough FEV1 at Days 29 and 169 and in trough FVC at Days 29, 169, and 337, the number of exacerbations per patient, the number of patients with ≥1 exacerbation, and the time to first exacerbation-related hospitalization. Exacerbations were defined as a complex of respiratory events or symptoms that lasted ≥3 days and required treatment with antibiotics and/or systemic corticosteroids, or prompted the investigator to change the patient’s regular respiratory medication. Major inclusion criteria included patients with a diagnosis of COPD, 40 years of age or over, a prebronchodilator FEV1 of ≤60% of predicted normal and a ratio of FEV1 to FVC of ≤70%, and a smoking history of 10 pack-years or more.2

FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity. 

Chart reprinted from Respir Med. 104(10):1460-1472. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium RESPIMAT® plus usual therapy in COPD patients. ©2010, with permission from Elsevier.

  • LAMA, long-acting muscarinic antagonist; HR, hazard ratio; CI, confidence interval.

FAQs

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SPIRIVA RESPIMAT has been shown to help reduce exacerbations in patients with COPD. In a 1-year, randomized, double-blind, parallel group study involving 3991 patients with COPD, SPIRIVA RESPIMAT reduced the risk of COPD exacerbations by 31% compared to placebo. [HR=0.69 (95% CI, 0.625, 0.769); P<0.0001 (log-rank test)]2

In a 1-year, randomized, double-blind, parallel group study involving 3991 patients with COPD, SPIRIVA RESPIMAT significantly reduced the risk of exacerbation-related hospitalizations by 27% compared to placebo. [HR=0.73 (95% CI, 0.589, 0.901); P<0.0191 (log-rank test)]2

INDICATIONS

SPIRIVA RESPIMAT, 2.5mcg, is 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.

SPIRIVA RESPIMAT, 1.25mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.

SPIRIVA RESPIMAT is not indicated for relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any component of this product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.

SPIRIVA RESPIMAT is intended as a once-daily maintenance treatment for COPD and asthma, and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2-agonist should be used.

Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA RESPIMAT. If such a reaction occurs, discontinue SPIRIVA RESPIMAT at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA RESPIMAT.

Inhaled medicines, including SPIRIVA RESPIMAT, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short-acting beta2-agonist, such as albuterol. Treatment with SPIRIVA RESPIMAT should be stopped and other treatments considered.

SPIRIVA RESPIMAT should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Since dizziness and blurred vision may occur with the use of SPIRIVA RESPIMAT, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.

SPIRIVA RESPIMAT should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) treated with SPIRIVA RESPIMAT should be monitored closely for anticholinergic side effects.

The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in COPD trials were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

The most common adverse reactions >2% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in asthma trials in adults were pharyngitis 15.9% (12.4%), headache 3.8% (2.7%), bronchitis 3.3% (1.4%), and sinusitis 2.7% (1.4%). The adverse reaction profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

SPIRIVA RESPIMAT may interact additively with concomitantly used anticholinergic medications. Avoid administration of SPIRIVA RESPIMAT with other anticholinergic-containing drugs.

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

CL-SVR-100065 2.15.2017

Please see full Prescribing Information, including Instructions for Use, for SPIRIVA RESPIMAT.

References

  1. SPIRIVA RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; January 2025.

  2. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium RESPIMAT® plus usual therapy in COPD patients. Respir Med. 2010;104(10):1460-1472.