The number of people with asthma, especially children, continues to rise dramatically in the United States. The disease now affects more than 17 million Americans(1) (one third of whom are children(2)) and inadequate treatment may have serious consequences. A new asthma treatment just approved by the U.S. Food and Drug Administration (FDA) may help improve asthma control by enabling adults and children to use a simple breath-activated device to take a medication that helps to effectively treat their condition.

The new treatment, Flovent® Diskus® (fluticasone propionate inhalation powder), gives patients four years of age and older a new way to help control their asthma, delivering an inhaled corticosteroid via the easy-to-use, breath-activated Diskus device. Flovent Diskus, which helps reduce the airway inflammation that leads to asthma symptoms, will offer both children and adults a convenient and effective way to treat asthma, improve their lung function and help control their symptoms. The medication will be available in three strengths: 50mcg, 100mcg, and 250mcg.

Flovent Diskus is indicated for the maintenance treatment of asthma as preventive therapy in adult and pediatric patients four years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of whom may be able to reduce or eliminate their requirement for oral corticosteroids over time. Flovent Diskus is not indicated for the relief of acute bronchospasm.

"To effectively manage asthma, you need to address the underlying inflammation of the lungs' airways -- and according to national asthma treatment guidelines, inhaled corticosteroids are the most effective anti- inflammatory therapy for patients with persistent asthma," said Dr. Ketan Sheth, clinical assistant professor of pediatrics at Indiana University School of Medicine, head of the Allergy/Asthma section at the Arnett Clinic (Lafayette, Indiana) and a Flovent Diskus investigator. "Flovent Diskus is a welcome addition to the existing arsenal of asthma therapies."

The Diskus is a breath-activated powder delivery device. Because patients simply inhale the medication using the force of their own breath, there is no need for hand-breath coordination (required when using traditional aerosol inhalers). This, in turn, may make it easier for children and other patients to take this medication. Each Diskus, a plastic device about the size and shape of a hockey puck or cosmetic compact, contains 60 pre-measured doses of Flovent, up to a 30-day supply. (Most patients take one to two inhalations twice a day, depending on their asthma severity, once in the morning and once at night.) Each Diskus contains a built-in dose counter to help patients keep track of remaining doses of medication.

Asthma: The Role of Inflammation and Inhaled Corticosteroids

Inflammation is an underlying cause of asthma symptoms such as shortness of breath, wheezing, chest tightness, and cough. In patients with persistent asthma (i.e., symptoms more than twice a week), this inflammation is always present to some degree. If left untreated, inflammation may cause damage to the airways, leading to a worsening of lung health and a decline in lung function(3).

According to asthma treatment guidelines developed by the National Heart, Lung, and Blood Institute (NHLBI), daily inhaled corticosteroid therapy is the most effective long-term controller medication for persistent asthma(3). Regular use of inhaled corticosteroids has been shown to decrease asthma symptoms(3), decrease use of quick-relief medications(3), significantly improve lung function(3), and reduce the risk of asthma attacks(3).

Inhaled corticosteroids should not be confused with anabolic steroids, which are sometimes used illegally by athletes to build muscle mass. Inhaled corticosteroids, which are based on natural anti-inflammatory substances found in the body, are a very different type of drug and have earned a respected place in the practice of medicine. They are used to treat asthma because they reduce the swelling and irritation in the walls of the air passages in the lungs and help ease breathing problems.

Inhaled corticosteroids are a topical medication: they deliver a small amount of medicine directly to the lungs. They are therefore able to be used in much lower doses -- with less chance for unwanted side effects -- than oral corticosteroids, which are often taken in much larger doses and are distributed throughout the entire body.

Clinical Trials: Adults and Adolescents

Four clinical trials involving more than 1,000 patients 12 years of age and older showed that at all recommended dosages of Flovent Diskus (100mcg, 250mcg, and 500 mcg twice daily), significant improvement in lung function over placebo was noted. (Measures of lung function included both FEV(1), or "forced expiratory volume in one second," and AM PEFR, or "morning peak expiratory flow rate.") Lung function, as measured by FEV(1), improved significantly by the first week of treatment, and improvement was maintained for up to one year or more. Note: Improvement in asthma control following administration of Flovent can occur within 24 hours of beginning treatment, although maximum benefit may not be achieved for one or two weeks or longer after starting treatment.

Patients receiving Flovent Diskus had significant decreases in asthma symptoms, rescue albuterol use and nighttime awakenings when compared to patients who received placebo.

Patients on all recommended dosages were also significantly less likely to withdraw from the trial due to worsening asthma (as defined by predetermined criteria for lack of efficacy including lung function and patient-recorded variables such as AM PEFR, albuterol use and nighttime awakenings due to asthma) compared with placebo.

Clinical Trials: Pediatrics

In a 12-week clinical trial involving 437 pediatric patients aged 4 to 11 years, approximately half of whom were receiving inhaled corticosteroids at baseline, doses of Flovent Diskus 50mcg and 100mcg twice daily significantly improved lung function compared to placebo. (FEV(1) improved by 16 percent from baseline at trial endpoint with Flovent Diskus 50mcg, 18 percent with Flovent Diskus 100mcg and 7 percent with placebo. AM PEFR improved by 26 percent with Flovent Diskus 50mcg, 27 percent with Flovent Diskus 100mcg and 14 percent with placebo).

In addition, patients receiving Flovent Diskus at 50 mcg or 100 mcg achieved a 44 percent and 51 percent decrease in asthma symptoms, respectively, compared to a 3 percent decrease in patients receiving placebo. Patients receiving Flovent Diskus at 50 mcg or 100 mcg achieved a 47 percent and 53 percent decrease in albuterol use, respectively, compared to a 6 percent increase in patients receiving placebo. Patients receiving Flovent Diskus at 50 mcg or 100 mcg achieved a 60 percent and 75 percent decrease in nighttime awakenings, respectively, compared to a 117 percent increase in patients receiving placebo.

Patients taking Flovent Diskus were significantly less likely than those taking placebo to withdraw from the trial due to worsening asthma. Lung function improved significantly by the first week of treatment. One hundred ninety-two patients received fluticasone propionate for up to one year during an open-label extension of this study. Data from this open-label extension suggested that lung function improvements could be maintained up to one year.

Adult/adolescent and pediatric clinical trials with Flovent Diskus showed that it was generally well tolerated and had a favorable safety profile at recommended doses. The most common adverse events reported in the studies at doses up to 500 mcg twice a day (greater than or equal to 8%) were upper respiratory tract infection (14-21%), throat irritation (3-22%), sinus infection/sinusitis (6-10%), oral thrush (less than 1-9%), nausea and vomiting (1-8%), bronchitis (0-8%), and headache (2-14%).

Common adverse events reported in patients in one study of oral- corticosteroid-dependent adult patients (n=111), at doses of 500 mcg or 1000 mcg twice daily (greater than 10%) were: nasal congestion and blockage (16%), oral thrush (31%), rhinitis (13%), sinus infection/sinusitis (33%), upper respiratory tract infection (31%), arthralgia and articular rheumatism (17%), muscle pain (12%) and malaise and fatigue (16%).

Particular care is needed for patients who are being transferred from oral corticosteroids to inhaled corticosteroids because, while adjusting to the switch, a patient may not be able to heal after surgery, infection, or serious injury. Patients should be warned to avoid exposure to chicken pox and measles, and if they are exposed, to consult their physicians without delay.

• References
  • (1) "HHS Targets Efforts on Asthma," HHS Fact Sheet, U.S. Department of Health and Human Services, May 4, 1999.
  • (2) Pediatric Asthma: Promoting Best Practices. Guide for Managing Asthma in Children. 1999. The American Academy of Allergy, Asthma & Immunology, Inc.
  • (3) Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma, National Heart, Lung, and Blood Institute, National Institutes of Health. NIH Publication No. 97-4051, July 1997.