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Steroid-sparing SPIRIVA RESPIMAT can improve lung function in children with asthma1-5

Symptomatic Moderate Asthma Age 6 to 11

For children aged 6-11 years with symptomatic moderate asthma, studies showed a statistically significant improvement vs placebo in peak FEV₁ response, with an adjusted mean difference of 170 mL.

Symptomatic Severe Asthma Age 6 to 11

For children aged 6-11 years with symptomatic severe asthma, studies showed an improvement vs placebo in peak FEV₁ response, with an adjusted mean difference of 35 mL.

Symptomatic Severe Asthma Age 12 to 17

For adolescents aged 12-17 years with symptomatic severe asthma, studies showed a statistically significant improvement vs placebo in peak FEV₁ response, with an adjusted mean difference of 111 mL.

FEV₁ (0-3h), forced expiratory volume in 1 second within 3 hours post dosing; CI, confidence interval; FEV₁, forced expiratory volume in 1 second.

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Study Design

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The 48-week pediatric trial was a randomized, double-blind, parallel-group comparison of SPIRIVA RESPIMAT, 1.25 mcg/puff

(2 puffs, once daily), with background treatment of at least ICS, and placebo with background treatment of at least ICS, over 48 weeks. The primary efficacy endpoint was change from pretreatment baseline in peak FEV₁ (0-3h) at week 24. Study participants were aged 6-11 years, had moderate asthma, and were on background maintenance therapy of either ICS alone or ICS with a leukotriene receptor antagonist (LTRA).1,2

ICS, inhaled corticosteroid; FEV₁ (0-3h), forced expiratory volume in 1 second within 3 hours post dosing.

The 12-week pediatric trial was a randomized, double-blind, parallel-group comparison of SPIRIVA RESPIMAT, 1.25 mcg/puff 
(2 puffs, once daily), with background treatment of ICS plus ≥1 controller medications, and placebo with background treatment of ICS plus ≥1 controller medications, over 12 weeks. The primary efficacy endpoint was change from pretreatment baseline in peak FEV₁ (0-3h). Study participants were aged 6 to 11 years and had severe asthma despite use of ICS plus ≥1 controller medication(s).1,3

ICS, inhaled corticosteroid; FEV₁ (0-3h), forced expiratory volume in 1 second within 3 hours post dosing.

Trial 1 was a 12-week, randomized, double-blind, parallel-group comparison of SPIRIVA RESPIMAT 1.25 mcg/puff (2 puffs once daily) on a background of medium-dose ICS (200-400 mcg budesonide or equivalent in patients aged 12-14 years and 400-800 mcg budesonide or equivalent in patients aged 15-17 years) or high-dose ICS (>400 mcg budesonide or equivalent in patients aged 12-14 years and 800-1600 mcg budesonide or equivalent in patients aged 15-17 years) + ≥1 (with high-dose ICS) or ≥2 (with medium-dose ICS) controller medications (eg, LABA) and placebo on a background of medium- or high-dose ICS + ≥1 controller medications (eg, LABA). The primary endpoint was change in FEV1 (0-3h) from baseline. Study participants were aged 12-17 years with severe symptomatic asthma despite use of ICS + ≥1 controller medication.4

ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; FEV1 (0-3h), forced expiratory volume in 1 second within 3 hours post dosing.

INDICATION

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.

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 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

  1. SPIRIVA RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; November 2021.

  2. Vogelberg C, Engel M, Laki I, et al. Tiotropium add-on therapy improves lung function in children with symptomatic moderate asthma. J Allergy Clin Immunol Pract. 2018;6(6):2160-2162.e9.

  3. Szefler SJ, Murphy K, Harper T III, et al. A phase III randomized controlled trial of tiotropium add-on therapy in children with severe symptomatic asthma. J Allergy Clin Immunol. 2017;140(5):1277-1287.

  4. Hamelmann E, Bernstein JA, Vandewalker M, et al. A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma. Eur Respir J. 2017;49(1):1601100.

  5. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.