Dual Bronchodilation of COMBIVENT RESPIMAT Is Proven Clinically Effective1
Results from a randomized, double-blind, double-dummy parallel-group, 12-week trial of 1460 adult patients conducted to demonstrate the efficacy and safety of COMBIVENT RESPIMAT (20/100 mcg) in COPD. Patients were randomized to one of the following active treatments: COMBIVENT RESPIMAT (20/100 mcg) (n=486), CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg) (n=491), and ipratropium bromide delivered by the RESPIMAT inhaler (20 mcg) (n=483) administered 4 times a day.1
The 3 primary efficacy comparisons were: (i) non-inferiority of COMBIVENT RESPIMAT to CFC-propelled COMBIVENT Inhalation Aerosol for the FEV1 AUC0-6h on Test Day 85; (ii) superiority of COMBIVENT RESPIMAT to ipratropium RESPIMAT for the FEV1 AUC0-4h on Test Day 85, to demonstrate the contribution of albuterol in the combination product, and (iii) non-inferiority of COMBIVENT RESPIMAT in comparison to ipratropium RESPIMAT for FEV1 AUC4-6h on Test Day 85, to demonstrate the contribution of ipratropium in the combination product.1
*COPD=chronic obstructive pulmonary disease.
†FEV1=forced expiratory volume in 1 second.
- COMBIVENT RESPIMAT Prescribing Information. Ridgefield CT; Boehringer Ingelheim Pharmaceuticals, Inc; 2016.
- Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
- Wachtel H, Kattenbeck S, Dunne S, Disse B. The RESPIMAT® development story: patient-centric innovation. Pulm Ther. 2017;3(1):1-12.
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.