Azithromycin significantly shortens the duration of asthma-like episodes in young children, according to a new randomized controlled trial.

“We’ve shown in the new study that taking out the bacteria has a very dramatic effect,” Dr. Hans Bisgaard of the Copenhagen Prospective Studies of Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, told Reuters Health in a telephone interview.

“Preschool viral wheeze” is a leading cause of hospital admission among young children, and current treatments are largely ineffective. As the name suggests, these episodes are generally considered to be viral. But in the COPSAC cohort, Dr. Bisgaard and colleagues had previously identified an association between airway bacteria and wheezing episodes.

To investigate whether antibiotic treatment might be beneficial, the researchers randomly assigned children one to three years old who had been diagnosed with recurrent asthma-like symptoms to receive a three-day course of azithromycin (10 mg/kg/day) or placebo when they had episodes of “troublesome lung symptoms” lasting at least three days. A total of 158 episodes in 72 children were randomized.

he findings were published online December 17 in The Lancet Respiratory Medicine.

On average, episodes lasted 3.4 days for children who received the antibiotic, versus 7.7 days for children who received placebo, shortening the episode by 63.3%. When treatment was initiated before day six of the episode, duration was reduced by 83%, versus 36% if treatment was initiated on or after the sixth day.

While antibiotics are not recommended for children experiencing these symptoms, they are frequently prescribed, Dr. Bisgaard noted. “It is in clinical practice actually used very extensively, there’s just been no evidence to document why, and the international guidelines recommend not to use antibiotics,” he said. Nevertheless, he added, “it’s in effect reducing symptoms by half, which is more than you can do with any other treatment.”

Dr. Bisgaard said he hopes to see others attempt to replicate the findings, and also to investigate whether simpler antibiotics would also be effective.

In an editorial accompanying the study, Dr. Jonathan Grigg of Queen Mary University of London in the U.K. notes that the use of “troublesome lung symptoms” as a primary outcome means the results should be interpreted with caution.

“The normal primary outcome in community-based trials of preschool wheeze is one that reflects clinically severe disease – eg. the need for unscheduled medical attention and hospital admission for physician-diagnosed wheeze,” he writes.

“We need to know if azithromycin really reduces clinically significant wheeze,” Dr. Grigg told Reuters Health by email. “We need to test this in a trial of children with severe wheeze attending hospital and use validated scoring for wheeze severity.”

For now, antibiotics should not be used in children with preschool wheeze, he added. “Wheeze episodes in children six months to five years are virtually all triggered by viral colds and antibiotics have no effect,” he said. “The study opens up a new area of research for this common condition. It is important that funders such as the MRC and NIHR support further research in this area.”

However, he added, “it is too early to say that this type of therapy will be clinically useful. Azithromycin should not be used to treat preschool wheeze without further evidence from large trials.”

The study was supported by the Lundbeck Foundation and others.


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