November 2000
ROCKVILLE, Md. - The Food and Drug Administration recently approved fluticasone propionate inhaled powder (Flovent Diskus, Glaxo Wellcome) for adults and children older than 4 years.
The new treatment gives patients a new way to control their asthma, delivering an inhaled corticosteroid with a breath-activated disk. Because patients simply inhale the medication using the force of their breath, there is no need for hand-breath coordination, which researchers feel may make it easier for children and other patients to use this medication, compared with traditional aerosol inhalers.
Fluticasone propionate for inhalation is indicated for maintenance treatment or preventive therapy in both adults and children and for asthmatic patients requiring oral corticosteroid therapy.
"Where I use fluticasone propionate inhaled powder and where I think [national asthma treatment] guidelines talk about using [it] is for anybody who has persistent asthma," said Ketan Sheth, MD,clinical assistant professor of pediatrics at the Indiana University School of Medicine and head of the allergy/asthma section at the Arnett Clinic in Lafayette, Ind. "That would be for kids who are using albuterol three or four times a week or more."
The medication is not indicated for relieving bronchospasms.
Fluticasone propionate inhaled powder is available in three strengths: 50 mg, 100 mg and 250 mg.
If a child has "milder asthma, but still needs an inhaled steroid, I would probably start fluticasone propionate inhaled powder at 50 mg twice daily (BID)," Sheth said. Dosing may go as high as needed to control a child's asthma. "Because the alternatives are being on oral steroids all of the time, being in the hospital frequently and having to go to the emergency room frequently, which are all pretty disruptive."
In a 12-week trial involving 437 children between the ages of 4 and 11, half of whom were receiving inhaled corticosteroids at baseline, BID 50 mg and 100 mg doses of fluticasone propionate improved lung function compared with placebo. Forced expiratory volume in one second improved by 16% at 12 weeks at the 50 mg dose, 18% with the 100 mg dose and 7% with placebo. Morning peak expiratory rate improved by 26% at the 50 mg dose, 27% with the 100 mg dose and 14% with placebo.
Children using fluticasone propionate at the 50 mg and 100 mg doses also achieved a 44% and 51% decrease in asthma symptoms, respectively, compared with a 3% decrease in patients receiving placebo. Additionally, patients using the 50 mg and 100 mg doses achieved a 47% and 53% decrease in albuterol use, compared with a 6% decrease in children receiving placebo. Nighttime awakenings also decreased 60% (50 mg) and 75% (100 mg) with fluticasone, compared with a 117% increase in children receiving placebo.
Children using fluticasone were also less likely to withdraw from the trial due to worsening asthma, compared with those receiving placebo. Lung function improved significantly within one week of treatment, although maximum benefit may not be achieved until one or two weeks after starting treatment.
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An open-label extension including 192 patients using fluticasone showed that lung function improvements could be maintained for up to one year.
Other trials have shown fluticasone propionate inhaled powder to be generally well tolerated with a favorable safety profile at recommended doses. The most common adverse events reported in studies using up to 500 µg BID were throat irritation (3% to 22%), upper respiratory tract infection (14% to 21%), headache (2% to 14%), sinus infection/sinusitis (6% to 10%), oral thrush (<1% to 9%), nausea and vomiting (1% to 8%) and bronchitis (0% to 8%).
Researchers noted that particular care is needed for patients who are being transferred from oral corticosteroids to inhaled steroids, because they may not be able to heal after surgery, infection or serious injury while adjusting to the switch. Additionally, patients should be warned to avoid varicella and measles exposure and to consult a physician as soon as possible if exposed.
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