FDA approves Combivent Respimat Inhalation Spray for patients with COPD

October 10, 2011

FDA has approved ipratropium bromide and albuterol (Combivent Respimat Inhalation Spray, Boehringer Ingelheim) for patients using a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

FDA has approved ipratropium bromide and albuterol (Combivent Respimat Inhalation Spray, Boehringer Ingelheim), a propellant-free product, for patients with chronic obstructive pulmonary disease (COPD) using a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Combivent Respimat uses a slow-moving mist to deliver the same active ingredients found in Combivent Inhalation Aerosol in a metered-dose inhaler (Combivent MDI).

In a 12-week, randomized, double-blind, placebo- and active-controlled clinical trial, Combivent Respimat was shown to be clinically comparable to Combivent MDI, in terms of FEV1. FEV1 is the maximal amount of air that can be forcefully exhaled in 1 second. In the study, treatment was adminstered to patients with COPD 4 times a day.

Combivent MDI and Combivent Respimat are the only short-acting bronchodilator products that offer 2 different medications in a single inhaler. Clinical studies of patients with COPD have shown that the combination of ipratropium bromide and albuterol sulfate provides patients with significantly greater improvement in lung function than either component does alone.

Combivent Respimat uses a new type of inhaler with a propellant-free delivery mechanism to produce a slow-moving mist. Combivent Respimat requires 1 inhalation per dose, compared to Combivent MDI, which requires 2 inhalations per dose.Combivent Respimat also offers a dose indicator to inform patients of the amount of medication remaining in the inhaler.

“Combivent Respimat is a testament to our company’s dedication and focus on making meaningful developments in respiratory medicine,” said Greg Behar, president and CEO, Boehringer Ingelheim. “Leveraging our extensive respiratory therapeutic experience and a long history of bringing innovative medicines to patients, we continue to expand our strong clinical program examining the potential of several late-stage investigational compounds also delivered by the Respimat inhaler.”

Combivent Respimat was developed in response to the Montreal Protocol, an international treaty requiring the phase-out of inhalers that use chlorofluorocarbons (CFCs) as propellants, such as Combivent MDI. Combivent Respimat uses a spring mechanism to release the medication, rather than a propellant, so it does not release CFCs or hydrofluoroalkane (HFA) propellants.

COPD is also known as chronic bronchitis and emphysema. As many as 24 million Americans may have COPD, even those who haven't smoked in years, and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills 1 person every 4 minutes, resulting in more deaths each year than from breast cancer and diabetes combined.

Common symptoms of COPD include coughing, with or without mucus, or shortness of breath. These symptoms are often confused with normal signs of aging. As COPD progresses, symptoms tend to get worse and more damage occurs in the lungs. Breathing gradually becomes more difficult, until people with COPD feel as if they are inhaling and exhaling through a small straw.

Combivent Inhalation Aerosol and Combivent Respimat are contraindicated in patients hypersensitive to any components of the drug product or to atropine or its derivatives. Combivent Inhalation Aerosol is also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut.

Combivent Inhalation Aerosol and Combivent Respimat can produce paradoxical bronchospasm that can be life-threatening. If it occurs, the Combivent therapy should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister of Combivent Inhalation Aerosol.

Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after administration of ipratropium bromide or albuterol sulfate. If such a reaction occurs, therapy with Combivent should be stopped at once and alternative treatment should be considered.