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Albuterol with HFA Propellant Safe in Children Less than Two Years Old: Presented at AAAAI

By Paula Moyer

MIAMI BEACH, FL -- March 10, 2006 -- Albuterol (Ventolin) in a metered dose inhaler (MDI) that uses hydrofluoroalkane (HFA) has a similar rate of adverse effects as placebo in children less than 2 years old, according to a team of investigators who presented their findings here at the 62^nd annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI).

The propellant HFA was developed to replace chlorofluorocarbon (CFC), which is being phased out by mandate as an ozone-threatening pollutant. Although HFA has been shown to be safe in albuterol-containing MDIs for children 4 years old or more, albuterol with HFA was not tested in children younger than 2 years, said principal investigator Angela Davis-Allen, Research Coordinator, GlaxoSmithKline, Research Triangle Park, North Carolina, United States.

Asthma is the most common chronic disease in children 4 years old and younger in the United States, affecting 7.5% of them. Ms. Davis-Allen wanted to know if the environmentally friendly formulation albuterol with HFA would be safe in this population.

"Albuterol at two doses -- 90 mcg three times daily and 180 mcg three times daily -- had a safety profile similar to placebo in children in this age group," Dr. Davis-Allen said, during her presentation on March 6^th. "We saw no significant changes in laboratory parameters, QT intervals, or drug-related tachycardia."

Although the study was not powered to demonstrate efficacy, she and her co-investigators noted "trends for improvements" in symptoms scores, she added.

The investigators obtained safety data from a randomized, double-blind, parallel group, placebo-controlled multicenter study that compared albuterol with HFA at the dosages of 90 mcg and 180 mcg three times daily to placebo. The treatment duration was 4 weeks, and the 81 children in the study used a valved holding chamber and face mask to assist with drug delivery.

Subjects were no more than 24 months old and had a history of bronchospasm that was consistent with obstructive airways disease.

Overall rates of adverse events during treatment were 59% in the 90 mcg group, 76% in the 180 mcg group, and 71% in the placebo group. The most frequently reported adverse events were pyrexia, occurring in 24% of those on 90 mcg, 7% of those on 180 mcg, and 11% of those in the placebo group.

The investigators documented eight upper respiratory tract infections (URTIs), three in the placebo group and five in the 90 mcg group. There were nine events of non-drugrelated sinus tachycardia, which occurred in 17% of 180 mcg subjects and in 7% each in the placebo group and the 90 mcg group.

One subject in each of the albuterol treatment groups experienced drug-related agitation or restlessness, or mild sinus arrhythmia. The investigators documented no drug-related QT prolongation, and no abnormal serum potassium and glucose levels, in either of the albuterol treatment groups.

They concluded that the study provided additional safety information regarding the use of HFA as a propellant for albuterol during the treatment of bronchospasm in children 2 years old and younger.

The study was funded by GlaxoSmithKline Inc., which manufactures Ventolin.


[Presentation title: Safety of Ventolin HFA® MDI in Children Birth-<24 Months Old With Symptoms of Bronchospasm. Abstract 757]

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