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Second Phase II Study of Lidocaine Solution in Asthma Initiated
The double-blind, randomized, placebo-controlled study with 92 subjects will be conducted in approximately 20 asthma centers in two countries (Germany and Poland) and to evaluate efficacy, tolerability and safety of nebulized lidocaine. The study’s primary endpoint will assess the efficacy in reducing the need for oral corticosteroids. The drug will be delivered to study subjects via the PARI eFLOW™ electronic nebulizer twice daily.
“We are optimistic about this trial due to the strength of the existing clinical data on the product,” comments A. Bruce Montgomery, M.D., CEO of Corus Pharma. “The open label studies conducted at Mayo Clinic showed good efficacy in these patients which we would like to confirm in a placebo-controlled study. These patients clearly need an alternative to chronic oral steroids.”
Asthma is a chronic disease characterized by constriction and inflammation of the lungs. Constriction is caused by a tightening of airway muscles, while inflammation is a swelling of the airway, usually due to irritation. Both of these components cause airways to narrow and may result in wheezing, coughing, chest tightness or shortness of breath.
There are more than 20 to 25 million asthmatics in the United States, with more than 60 percent treated with drugs. Five to ten percent of patients are considered severe asthmatics and require moderate to high doses of inhaled steroids, concomitant long-acting bronchodilators and sometimes oral steroids.
Source: Corus Pharma