SPIRIVA RESPIMAT 1.25 mcg has proven efficacy for uncontrolled asthma symptoms
The only LAMA proven to significantly reduce exacerbation rates when added to ICS/LABA in adults1,2
*Not statistically significant.
An asthma exacerbation was defined as an episode of progressive increase in ≥1 asthma symptom(s),
eg, shortness of breath, cough, wheezing, chest tightness, or a combination of these symptoms; or a 30% decrease in best morning PEF for ≥2 consecutive days that required initiation or increase in treatment with systemic steroids for ≥3 days.1
Add SPIRIVA RESPIMAT to improve lung function in adults with asthma1,2
In adult patients with moderate asthma taking medium-dose ICS at 24 weeks. Improvements were independent of underlying allergic status.2
LAMA, long-acting antimuscarinic agent; ICS, inhaled corticosteroid; LABA, long-acting beta₂-agonist; RR, rate ratio; CI, confidence interval; PEF, peak expiratory flow;
FEV1 (0-3h), forced expiratory volume in 1 second within 3 hours post dosing; FEV1, forced expiratory volume in 1 second.
Study Design
Trials 2 and 3 were randomized, double-blind, placebo-controlled, parallel-group comparisons of SPIRIVA RESPIMAT 1.25 mcg/puff (2 puffs, once daily) maintenance treatment on a background of at least medium-dose ICS, SPIRIVA RESPIMAT 2.5 mcg/puff (2 puffs, once daily), medium-dose ICS (400 mcg to 800 mcg budesonide or equivalent), salmeterol 50 mcg (twice daily), with background treatment of at least medium-dose ICS, or placebo with background treatment of at least medium-dose ICS for 24 weeks. Co-primary endpoints included peak FEV1 response (0-3h) and trough FEV1 response, measured at the end of the dosing interval (24h after dose). Study participants were non-current smokers aged 18-75 years with symptomatic asthma despite use of medium-dose ICS. Additional efficacy measures included the mean rate of asthma exacerbations (events), Asthma Control Questionnaire (ACQ), and Asthma Quality of Life Questionnaire (AQLQ). In Trial 2, the mean rate of events for exacerbations in SPIRIVA RESPIMAT 2.5 mcg + ICS (n=259) and placebo + ICS (n=265) were 0.08 and 0.24, respectively. In Trial 3, the mean rate of events for exacerbations in SPIRIVA RESPIMAT 2.5 mcg + ICS (n=256) and placebo + ICS (n=253) were 0.13 and 0.18, respectively. These trials were not powered to demonstrate noninferiority of SPIRIVA RESPIMAT to salmeterol, and comparisons between SPIRIVA RESPIMAT and salmeterol cannot be made. Salmeterol efficacy was assessed against placebo on a background of ICS.1,2
ICS, inhaled corticosteroid; FEV1, forced expiratory volume in 1 second.
SPIRIVA RESPIMAT, 1.25 mcg, 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.
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 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 >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.
Please see full Prescribing Information, including Instructions for Use, for SPIRIVA RESPIMAT.
CL-SVR-0044 2.15.2017
REFERENCES
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SPIRIVA RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; November 2021.
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Kerstjens HAM, Casale TB, Bleecker ER, et al. Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials. Lancet Respir Med. 2015;3(5):367-376.
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Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.