A new asthma treatment available in the US starting yesterday may change the way many of the 17 million(2) Americans with asthma manage their condition.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is the first product that allows people to effectively treat the two main components of asthma, inflammation and bronchoconstriction, with one easy-to-use device. Both components play crucial roles in causing asthma symptoms such as shortness of breath, wheezing, chest tightness, and coughing. Patients take one inhalation of Advair twice each day from the Diskus device, a breath-activated powder inhaler. (Advair Diskus does not replace fast-acting inhalers for the treatment of sudden symptoms).

"Advair Diskus offers two major benefits to patients -- it's very effective and it's easy to use," said Stuart Stoloff, MD, a member of the expert medical panel that helped the National Institutes of Health develop current asthma treatment guidelines, and an associate clinical professor at the University of Nevada in Reno. "It gets to the root of the problem, making it easy for people to treat the two main components of asthma, literally in the same breath."

Research has established that the two main causes of asthma symptoms are inflammation, or swelling and irritation inside the airways, and bronchoconstriction, tightening of the muscles that surround the airways. Optimal therapy for many asthma patients requires treatment of both of these components. Advair Diskus contains both an inhaled corticosteroid (fluticasone propionate) to reduce inflammation and an inhaled long-acting bronchodilator (salmeterol) to help prevent bronchoconstriction.

Trials involving more than 1,200 patients evaluated Advair Diskus using several measures, including lung function, protection against worsening asthma, rescue medication use, and asthma symptoms.(3,4)

In a clinical trial(3) conducted in patients who were symptomatic while receiving salmeterol alone or low to moderate doses of inhaled corticosteroids alone, Advair Diskus 100/50 was compared with fluticasone propionate 100 mcg alone and salmeterol 50 mcg inhalation powders alone, resulting in significantly greater improvement in lung function and superior protection against worsening asthma.

Other endpoints that were measured in this study showed that Advair Diskus 100/50, compared with fluticasone propionate 100 mcg alone or salmeterol 50 mcg alone provided significantly more symptom-free days and resulted in significantly greater reduction in the need for rescue albuterol.

In addition, most of the patients who received Advair Diskus 100/50 had a clinically significant improvement in lung function within 30-60 minutes of taking the first dose.

Clinical trials with Advair Diskus showed that it was generally well tolerated and had a safety profile similar to that of its individual components given concurrently at the same doses.

The Diskus device is easy to use: patients simply open, click the lever to prepare the dose, inhale when they are ready, and then close the device. Unlike traditional aerosol inhalers, the Diskus is breath-activated: patients use their own breath to inhale pre-measured doses of medication. No hand-breath coordination or spacers are needed, and research shows that even patients with severely compromised lung function (FEV1 20-30 percent of predicted) are able to get consistent and effective doses. A built-in dose counter helps patients keep track of remaining doses. Each Diskus device contains 60 doses (a 30-day supply of medication). Doses are individually measured and sealed in blister strips that help protect the medication from temperature and humidity changes.

Advair Diskus is currently available in 38 countries, where it is also sold under the trade names Seretide(R) and Viani(R). It was first approved in Sweden in December 1998 and is now marketed in many parts of Europe, Latin America, Asia, and in Canada. The product was introduced in the United Kingdom in 1999, where it is called Seretide. "The interest in Seretide has been remarkably high," said Tim Clark, MD, professor of pulmonary medicine, National Heart and Lung Institute, Imperial College, London. "Both patients and physicians appreciate the combination of convenience and effectiveness that this treatment offers. It simplifies what many people need to do to help keep their asthma under control."

Advair Diskus is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 12 years of age and older. It is not indicated for the relief of acute bronchospasm. Advair Diskus is available in three strengths for dosing flexibility: Advair Diskus 100/50, Advair Diskus 250/50 and Advair Diskus 500/50. Each strength of Advair Diskus contains 50 mcg of salmeterol and either 100 mcg, 250 mcg or 500 mcg of fluticasone propionate. Advair Diskus does not replace fast-acting inhalers for the treatment of sudden symptoms and should not be taken more than twice a day. People switching from an oral steroid like prednisone to Advair, which contains an inhaled steroid, need to be especially careful. While adjusting to the switch, a person is not as able to heal after surgery, infection, or serious injury. Advair should be used with caution in patients with cardiovascular disorders. Some patients may experience an increase in blood pressure or heart rate.

References

1. Boulet LP, et al. Comparison of Diskus inhaler, a new multidose powder inhaler, with Diskhaler inhaler for the delivery of salmeterol to asthmatic patients. J Asthma. 1995;32(6):429-436.

2. US Centers for Disease Control and Prevention. Forecasted state- specific estimates of self-reported asthma prevalence - United States, 1998. Morbidity and Mortality Weekly Report. 1998;47.

3. Kavuru M, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2000 June;105 (6, Part 1):1108-1116.

4. Shapiro G, et al. Combined salmeterol 50 mcg and fluticasone propionate 250 mcg in the Diskus device for the treatment of asthma. Am Jr Respir Crit Care Med. 2000;161:527-534. For full Advair Diskus prescribing information, please contact Lisa Behrens or Bert Kittner at 919-483-2839.