SPIRIVA RESPIMAT 1.25 mcg/puff—for uncontrolled asthma in patients ages 6 and older! OPEN

An expanded indication adds new expectations for SPIRIVA RESPIMAT—now for the treatment of asthma in patients ages 6 and older!

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SPIRIVA RESPIMAT |
1.25 mcg/Puff (2 Puffs, Once Daily)

Efficacy in Asthma Patients

For uncontrolled asthma in patients ≥6 years taking ICS or ICS + LABA, SPIRIVA RESPIMAT (tiotropium bromide) is an add-on treatment for asthma with proven efficacy.

In clinical trials, lung function was defined using peak FEV1, 0-3hr (forced expiratory volume in 1 second within 3 hours post-dosing) and trough (predose) FEV1 values.¹

In the treatment of asthma, the maximum benefits in lung function may take up to 4 to 8 weeks of dosing.

Improved lung function in patients on an ICS

In 2 pivotal trials, SPIRIVA RESPIMAT significantly increased peak FEV1, 0-3hr and trough FEV1 vs placebo at 24 weeks. All patients in these trials were on ICS background therapy.¹

TRIAL 2
SPIRIVA RESPIMAT + ICS and Salmeterol + ICS Increased Peak FEV1, 0-3hr and Trough FEV1 as Measured vs Placebo at 24 Weeks in Trial 21-3

TRIAL 3
SPIRIVA RESPIMAT + ICS and Salmeterol + ICS Increased Peak FEV1, 0-3hr and Trough FEV1 as Measured vs Placebo at 24 Weeks in Trial 31-3

Medium-dose ICS = 400 mcg to 800 mcg budesonide or equivalent.¹
CI = Confidence Interval
mL = Milliliters


Study participants were adult patients with moderate asthma taking medium-dose ICS.¹

This trial was not designed to test the noninferiority of SPIRIVA RESPIMAT to salmeterol. Salmeterol efficacy was assessed between salmeterol + ICS versus placebo + ICS.²

Improvements in peak FEV1, 0-3hr and trough FEV1 were independent of underlying allergic status.²

Study Design

Trials 2 and 3 were 2 randomized, double-blind, placebo-controlled, parallel-group comparisons of maintenance treatment on SPIRIVA RESPIMAT, 1.25 mcg/puff (2 puffs, once daily), with background treatment of at least medium-dose ICS (400 mcg to 800 mcg budesonide or equivalent in all arms); SPIRIVA RESPIMAT, 2.5 mcg/puff (2 puffs, once daily), with background treatment of at least medium-dose ICS; salmeterol, 50 mcg (twice daily), with background treatment of at least medium-dose ICS; and placebo with background treatment of at least medium-dose ICS, for 24 weeks. The coprimary efficacy endpoints were change from pretreatment baseline in peak FEV1, 0-3hr and change from pretreatment baseline in trough FEV1 at week 24. Study participants were not current smokers, aged 18–75 years, who had symptomatic asthma despite use of medium-dose ICS.¹

Improved lung function in patients on an ICS + LABA
Significantly Increased Peak FEV1, 0-3hr as Measured at 12 Weeks in Adolescent Patients Aged 12–17 Years1,2

Medium-dose ICS = 400 mcg to 800 mcg budesonide or equivalent, high-dose ICS = 800 mcg to 1600 mcg budesonide or equivalent.²
CI = Confidence Interval
mL = Milliliters


Key Secondary Endpoint

In the same pivotal trial, SPIRIVA RESPIMAT showed a 115-mL (p=0.0509 [95% CI: 0, 231 mL]) greater change in trough FEV1 vs placebo (345 mL vs 230 mL, respectively) at 12 weeks in adolescent patients with severe asthma.²*

83% of patients in the adolescent trial were on medium- or high-dose ICS + LABA.3

*This result was not statistically significant.

Study Design

The 12-week adolescent trial was a randomized, double-blind, parallel-group comparison of SPIRIVA RESPIMAT 1.25 mcg/puff (2 puffs, once daily) with background treatment of medium- or high-dose ICS plus ≥1 controller medications (eg, LABA); and placebo with background treatment of medium- or high-dose ICS plus ≥1 controller medications (eg, LABA), over 12 weeks. The primary efficacy endpoint was change from pretreatment baseline in peak FEV1, 0-3hr. Study participants were aged 12–17 years and had severe asthma despite use of ICS plus ≥1 controller medications (eg, LABA).¹,²

Reduced risk of asthma exacerbations
Delayed the Time to First Exacerbation Over 24 Weeks in Trials 2 and 3 (Additional Efficacy Measure)¹

Reduced the Rate of Exacerbations Over 24 Weeks in Trials 2 and 3 (Additional Efficacy Measure)¹

Medium-dose ICS = 400 mcg to 800 mcg budesonide or equivalent.¹
HR = hazard ratio
RR = rate ratio

*This result was not statistically significant.


Study participants were adult patients with moderate asthma taking medium-dose ICS³

Mean rate of exacerbations per patient year¹

An asthma exacerbation was defined as an episode of progressive increase in ≥1 asthma symptom(s) (like shortness of breath, cough, wheezing, chest tightness, or some combination of these symptoms) or a decrease of a patient’s best morning peak expiratory flow (PEF) of 30% from a patient’s mean morning PEF for ≥2 consecutive days that required the initiation or increase in treatment with systemic steroids for ≥3 days.¹

Study Design

Trials 2 and 3 were 2 randomized, double-blind, placebo-controlled, parallel-group comparisons of maintenance treatment on SPIRIVA RESPIMAT, 1.25 mcg/puff (2 puffs, once daily), with background treatment of at least medium-dose ICS (400 mcg to 800 mcg budesonide or equivalent in all arms); SPIRIVA RESPIMAT, 1.25 mcg/puff (2 puffs, once daily), with background treatment of at least medium-dose ICS; salmeterol, 50 mcg (twice daily), with background treatment of at least medium-dose ICS; and placebo with background treatment of at least medium-dose ICS, for 24 weeks. The coprimary efficacy endpoints were change from pretreatment baseline in peak FEV1, 0-3hr and change from pretreatment baseline in trough FEV1 at week 24. Study participants were not current smokers, aged 18–75 years, who had symptomatic asthma despite use of medium-dose ICS.¹

Effective for patients aged 12–17 years

In a 48-week pivotal trial, SPIRIVA RESPIMAT showed a greater change in peak FEV1 vs placebo at week 24 (primary endpoint) in adolescent patients (aged 12–17 years) with moderate asthma. All patients in these trials were on ICS background therapy.¹

Significantly Increased Peak FEV1, 0-3hr as Measured at 24 Weeks in Adolescent Patients Aged 12–17 Years¹,²

CI = Confidence Interval
mL = Milliliters


Key Secondary Endpoint

In the same pivotal trial, SPIRIVA RESPIMAT showed an 84-mL (p=0.1307 [95% CI: -2.5, 194 mL]) greater change in trough FEV1 vs placebo (367 mL and 283 mL, respectively) at week 24 in adolescent patients (aged 12–17 years) with moderate asthma.³*

*This result was not statistically significant.¹,³

Medium-dose ICS = 400 mcg to 800 mcg budesonide or equivalent, high-dose ICS = 800 mcg to 1600 mcg budesonide or equivalent.³

Study Design

The 48-week adolescent 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 medium-dose ICS (400 mcg to 800 mcg or equivalent for all arms) and placebo with background treatment of at least medium-dose over 48 weeks. The primary efficacy endpoint was change from pretreatment baseline in peak FEV1, 0-3hr at week 24. Secondary endpoints included trough (predose) FEV1 at week 24. Study participants were 12–17 years and had moderate asthma despite use of at least ICS.¹,²

SPIRIVA RESPIMAT is a once-daily maintenance bronchodilator and should not be used for immediate relief of breathing problems. In the event of an attack, a rapid-acting beta2-agonist should be used.¹

SPIRIVA RESPIMAT Works Differently

to Address Bronchoconstriction

Learn more

IMPORTANT SAFETY INFORMATION for SPIRIVA HANDIHALER and SPIRIVA RESPIMAT

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INDICATIONS

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

SPIRIVA is not indicated for relief of acute bronchospasm.

Important Safety Information

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

SPIRIVA is intended as a once-daily maintenance treatment 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.

More Important Safety Information

Important Safety Information (continued)

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA 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.

SPIRIVA HANDIHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

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

SPIRIVA 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, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.

SPIRIVA 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) and treated with SPIRIVA 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.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HANDIHALER (placebo) in COPD trials were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4-year trial with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HANDIHALER device. The HANDIHALER device should not be used for administering other medications.

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 for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER, including Instructions for Use.

INDICATIONS

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

SPIRIVA is not indicated for relief of acute bronchospasm.

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

IMPORTANT SAFETY INFORMATION for SPIRIVA HANDIHALER and SPIRIVA RESPIMAT

SEE MORE

INDICATIONS

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

SPIRIVA is not indicated for relief of acute bronchospasm.

Important Safety Information

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

SPIRIVA is intended as a once-daily maintenance treatment 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.

More Important Safety Information

Important Safety Information (continued)

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA 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.

SPIRIVA HANDIHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

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

SPIRIVA 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, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.

SPIRIVA 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) and treated with SPIRIVA 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.

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HANDIHALER (placebo) in COPD trials were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4-year trial with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HANDIHALER device. The HANDIHALER device should not be used for administering other medications.

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 for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER, including Instructions for Use.

INDICATIONS

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

SPIRIVA is not indicated for relief of acute bronchospasm.

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

References

  1. SPIRIVA [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2016.
  2. Kerstjens HA, 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.
  3. Data on File. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2014.