Here’s a scenario that may sound familiar:
A patient on ICS/LABA tells you they have been using their rescue inhaler more than
twice a week and have been experiencing symptoms like coughing or wheezing.

It could mean that their asthma may not be under control.1

Consider the signs:

  • Shortness of Breath, IconIncrease in symptoms,

    such as coughing,
    wheezing, chest tightness,
    or
    shortness of breath2
  • Rescue Inhaler Use, IconUses rescue inhaler more
    than twice a week2
  • Impact on Daily Life, IconMissed days of work
    or school
    because of asthma2,3
  • Nighttime Awakenings, IconNighttime
    awakenings2,4
  • Unscheduled Office Visits, IconUnscheduled
    office visits2

Consider the risk:

Patients with uncontrolled asthma, as defined by their Asthma Control Test (ACT) score, reported

2x more exacerbations during the previous year versus patients with controlled asthma5*

*A survey on asthma and its associated symptoms was sent via mail to 1 household member who provided responses for up to 5 household members. Participants included 10,139 asthma patients in the United States aged ≥18 years. Participants were asked (1) if they had ever been diagnosed with asthma by a doctor or health care professional and (2) if they had asthma symptoms such as coughing, wheezing, or shortness of breath in the past year. If they answered yes to both questions, they were asked to complete the ACT, which asks about asthma impairment over the previous 4 weeks in relation to impact on work, home, or school; frequency of shortness of breath; frequency of nighttime awakenings; frequency of rescue medication use; and (self-graded) level of asthma control. Participants with an ACT score of ≤19 were considered to be uncontrolled, while those with an ACT score of >19 were considered to be controlled.5

You might consider increasing
the dose of ICS.

But—increasing the dose of ICS may not be enough to achieve control6

Asthma treatment goals Achieved by increasing
the dose of ICS?
Fewer exacerbations requiring oral steroids6 No
Prevent unscheduled office visits6 No
Prevent acute care, ED, or hospital visits6 No

And, doubling the ICS dose may not significantly improve lung function.

Doubling the ICS Dose May Not Significantly Improve Lung Function

A comprehensive review of RCTs demonstrated that doubling the dose of ICS was not sufficient to significantly improve FEV1.7

Why increase the dose of ICS?

Take on asthma from another angle

ICS=inhaled corticosteroid; LABA=long-acting beta2-agonist; ED=emergency department; RCTs=randomized clinical trials; FEV1=forced expiratory volume in 1 second.

A systematic review of 8 RCTs, involving 1,669 participants with mild to moderate asthma, compared the clinical effectiveness and safety of increased versus stable doses of ICS for patients with mild to moderate asthma. If participants’ symptoms worsened, they were provided with an inhaler to use that contained extra doses of ICS or placebo. For 6 months to a year, participants were followed to determine whether higher doses of ICS helped more than those taking placebo during an attack. This meta-analysis showed a lack of strong clinical evidence supporting increasing the dose of ICS.6

Fifty-five randomized studies compared fluticasone at different nominal daily doses for the treatment of chronic asthma in both children and adults. Double-, single-, and unblinded studies were eligible for inclusion with participants aged 2 years and older who had a diagnosis of chronic asthma. Diagnosis was based on physician opinion, as well as criteria related to asthma symptoms, airway reversibility, and all bronchial hyper-responsiveness. Although improvements in FEV1 were seen in the 200 mcg vs 800-1000 mcg comparison, significant improvements in FEV1 were not seen in the following comparisons: 100 mcg vs 200 mcg, 100 mcg vs 400-500 mcg, or 400-500 mcg vs 800-1000 mcg.7

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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 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 including Instructions for Use and SPIRIVA HANDIHALER, including Patient Information and 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 is not indicated for relief of acute bronchospasm.

Please see full Prescribing Information for SPIRIVA RESPIMAT including Instructions for Use and SPIRIVA HANDIHALER, including Patient Information and 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 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 including Instructions for Use and SPIRIVA HANDIHALER, including Patient Information and 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 is not indicated for relief of acute bronchospasm.

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

References

  1. Murphy KR, Meltzer EO, Blaiss MS, Nathan RA, Stoloff SW, Doherty DE. Asthma management and control in the United States: results of the 2009 Asthma Insight and Management Survey. Allergy Asthma Proc. 2012;33(1):54-64.
  2. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program, National Institutes of Health, US Department of Health and Human Services. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: National Heart, Lung, and Blood Institute; 2007.
  3. Peters SP, Jones CA, Haselkorn T, Mink DR, Valacer DJ, Weiss ST. Real-world Evaluation of Asthma Control and Treatment (REACT): findings from a national Web-based survey. J Allergy Clin Immunol. 2007;119(6):1454-1461.
  4. Kaiser Permanente. Kaiser Foundation Health Plan of Washington. Asthma diagnosis and treatment guideline. https://wa.kaiserpermanente.org/static/pdf
    /public/guidelines/asthma.pdf
    . Updated July 2015. Accessed October 26, 2017.
  5. Fuhlbrigge A, Reed ML, Stempel DA, Ortega HO, Fanning K, Stanford RH. The status of asthma control in the U.S. adult population. Allergy Asthma Proc. 2009;30(5):529-33.
  6. Kew KM, Quinn M, Quon BS, Ducharme FM. Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children. Cochrane Database Syst Rev. 2016;6:CD007524. doi:10.1002/14651858.CD007524.pub4
  7. Adams NP, Bestall JC, Jones P, Lasserson TJ, Griffiths B, Cates CJ. Fluticasone at different doses for chronic asthma in adults and children. Cochrane Database Syst Rev. 2008;4:CD003534. doi:10.1002/14651858.CD003534.pub3.