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Dual Bronchodilation That Provides Superior Improvement in FEV1 Over Either of the 2 Components Alone1

Studies Conducted With CFC Metered-Dose Inhalers (MDIs)
Results from two 12-week, randomized, double-blind, active-controlled clinical trials: 1,067 patients with chronic obstructive pulmonary disease (COPD) were evaluated for the bronchodilator efficacy of COMBIVENT in a CFC inhaler (358 patients) in comparison to its components, ipratropium bromide (362 patients) and albuterol sulfate (347 patients). Mean FEV1 adjusted for test-day baseline FEV1, center, and treatment-by-center interaction.1
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More Patients Achieved a 15% Improvement in FEV1 After 15 Minutes With the Combination of Albuterol and Ipratropium Than With the Individual Components Alone2

Studies Conducted With CFC MDIs
A retrospective analysis of results from two 12-week, randomized, double-blind, active-controlled clinical trials: 1,067 patients with COPD were evaluated for the bronchodilator efficacy of COMBIVENT in a CFC inhaler (358 patients) in comparison to its components, ipratropium bromide (362 patients) and albuterol sulfate (347 patients). Percentage of patients demonstrating a 15% or greater increase in FEV1 (by time) compared with baseline values on 3 or more test days.2
  • This graph shows that the percentage of patients with an increase in FEV1 of at least 15% was greater with the combination therapy than monotherapy at all time points on the various testing days (P<0.05 at all time points)2
  • In a 12-week clinical trial in patients with COPD, COMBIVENT RESPIMAT was shown to be clinically comparable (statistically noninferior) to ipratropium bromide plus albuterol in a CFC inhaler in terms of mean FEV1 AUC0-63
    • In that clinical trial, the median time to onset of bronchodilation, defined as an FEV1 increase of 15% or greater from test-day baseline, for the COMBIVENT RESPIMAT group occurred at 13 minutes postdose on Day 13

*COPD = chronic obstructive pulmonary disease.

FEV1 = forced expiratory volume in 1 second.

CFC = chlorofluorocarbon.

References:
  1. Combivent Inhalation Aerosol Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2012.
  2. Dorinsky PM, Reisner C, Ferguson GT, et al. The combination of ipratropium and albuterol optimizes pulmonary function reversibility testing in patients with COPD. Chest. 1999;115(4):966-971.
  3. COMBIVENT RESPIMAT Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2014.

Indication for Use

COMBIVENT RESPIMAT is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Important Safety Information

COMBIVENT RESPIMAT is contraindicated in patients hypersensitive to any of the ingredients of the drug product or to atropine or its derivatives.

COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life-threatening. If it occurs, therapy with COMBIVENT RESPIMAT should be discontinued immediately and alternative therapy instituted.

The albuterol sulfate contained in COMBIVENT RESPIMAT can produce a clinically significant cardiovascular effect in some patients. If cardiovascular symptoms occur, COMBIVENT RESPIMAT may need to be discontinued.

COMBIVENT RESPIMAT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

COMBIVENT RESPIMAT contains ipratropium bromide and may increase intraocular pressure which may result in precipitation or worsening of narrow-angle glaucoma.

Patients should avoid spraying the aerosol into their eyes as this may cause acute eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos, or colored images in association with red eyes from conjunctival or corneal congestion. Advise patients to consult their physician immediately if any of these symptoms develop while using COMBIVENT RESPIMAT.

Ipratropium bromide also may cause urinary retention.

COMBIVENT RESPIMAT should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.

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

Do not exceed recommended dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.

Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur. If such a reaction occurs, therapy with COMBIVENT RESPIMAT should be stopped at once and alternative treatment should be considered.

COMBIVENT RESPIMAT contains albuterol and should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines. Albuterol may produce significant hypokalemia in some patients.

In clinical trials, the most common adverse reactions reported for COMBIVENT RESPIMAT were upper respiratory tract infection, nasopharyngitis, cough, bronchitis, headache, and dyspnea.

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

Caution is advised in co-administration of other beta-adrenergic agents, beta-receptor blocking agents, and non-potassium sparing diuretics. Extreme caution is advised with monoamine oxidase inhibitors or tricyclic antidepressants.

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Indication for Use

COMBIVENT RESPIMAT is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Important Safety Information

COMBIVENT RESPIMAT is contraindicated in patients hypersensitive to any of the ingredients of the drug product or to atropine or its derivatives.