Using Asmanex Twisthaler 220 mcg (mometasone furoate inhalation powder) has resulted in substantial improvement in lung function, decreased use of rescue medication, decreased incidence of nighttime awakenings and significant improvements in daytime symptoms, such as coughing and wheezing, says Schering-Plough Corporation (NYSE: SGP), the drug's manufacturer.

Substantial Symptomatic Improvement

"Asmanex is a highly effective first-line therapy that offers health care professionals and their patients a once daily therapy to help prevent persistent asthma symptoms," said Harold Nelson MD, Professor of Medicine, Department of Medicine, National Jewish Medical and Research Center, University of Colorado Health Science Center in Denver, Colorado.

In a clinical trial, Asmanex showed substantial improvement in lung function and decreased albuterol (rescue medication) use compared with placebo. The 12-week, multicenter, randomized, double-blind, placebo-controlled study involved 400 patients with persistent asthma who previously were dependent on inhaled corticosteroid therapy.

At the endpoint, patients who received Asmanex had a significant improvement both in nighttime awakenings and daytime symptoms.

Growing Public Health Problem

Treatment guidelines of the National Asthma Education and Prevention Program, or NAEPP , recommend single-ingredient, low-dose inhaled corticosteroid as the foundation of therapy for mild persistent asthma management.

Asthma is a chronic inflammatory lung disease that affects a growing number of Americans each year. The number of cases has grown steadily in the past 20 years, making it one of the leading public health problems in the US.

As many as 20 million people suffer from asthma. On an annual basis, this leads to at least two million emergency room visits and more than 5,000 deaths. Additionally, this accounts for an annual direct cost of treatment of $9.4 billion and approximately 14.5 million missed work days, according to Schering-Plough.

Asthma symptoms, such as coughing, wheezing and shortness of breath, occur during the day and night, impacting multiple aspects of patients' lives. Daytime symptoms can affect activities ranging from exercise to going to school or work. Nighttime symptoms interfere with patients' ability to sleep.

Mild to Moderate Side Effects

Asmanex was discovered and developed by Schering-Plough Research Institute and icurrently is approved for asthma treatment in more than 40 countries. Mometasone furoate, the active ingredient in Asmanex, first was introduced in the US in 1987 as the dermatologic ointment, Elocon (mometasone furoate ointment) and in 1997 as the nasal spray Nasonex (mometasone furoate monohydrate).

The following incidence of common adverse experiences is based on double-blind data from ten placebo-controlled clinical trials involving a total of 2,809 patients previously maintained on inhaled steroids and/or bronchodilators (1,140 males, 1,669 females, age 12-83 years), who were treated for up to 12 weeks with the Asmanex product, an active comparator, or placebo.

Adverse events generally were mild to moderate in severity and included headache, allergic rhinitis, pharyngitis, upper respiratory infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, dyspepsia, myalgia, abdominal pain and nausea.

Easu-to-Use Inhalation Device

Asmanex offers an effective inhaled corticosteroid to control asthma symptoms in an easy-to-use device. The Asmanex Twisthaler employs an inhalation-driven device that does not use a propellant, thus eliminating the need for hand-breath coordination, and it provides patients with a numeric dose counter that provides a visual indication of the remaining doses.

Recommended starting dose of Asmanex is one inhalation daily in the evening for patients previously treated with bronchodilators alone or inhaled corticosteroids. For patients previously maintained on oral corticosteroids, the recommended starting dose of Asmanex is two inhalations twice daily.

Asmanex is expected to be available in the US in the autumn of 2005.