Nebulized Pulmicort verified safe for kids' asthma

Inhalation of the corticosteroid budesonide (Pulmicort) via a nebulizer to treat asthma in children does not cause any problems with infection, cataracts, or growth, according to pooled data from a number of clinical trials.

The findings, lead author Stanley J. Szefler told Reuters Health, "provide reassuring information from a large database on the safety of this medication for use in the management of childhood asthma."

A nebulizer may be particularly suitable for treating asthma in children because, unlike pressurized metered-dose inhalers, it requires little coordination and no voluntary control of respiration.

Pulmicort Respules are the only form of inhaled corticosteroids approved by the FDA for use in nebulizers, and approved for treating children 1 to 8 years old, Dr. Szefler of the National Jewish Medical and Research Center, Denver, and colleagues note in the Annals of Allergy, Asthma and Immunology.

The researchers examined information on the safety of Pulmicort inhalation therapy in patients 18 years or younger from the databases of AstraZeneca, the drug's manufacturer.

The data covered nine clinical trials involving close to 1700 subjects, and information gathered since the worldwide approval of budesonide inhalation suspension in 1990.

Szefler's team found that there were no increased risks of cataracts, throat and mouth problems, or infections among children treated with nebulized Pulmicort.

There was only a "small" difference in short-term growth between children who did and did not get Pulmicort treatment in two of the five trials that looked at this factor.

So, the researchers conclude that short- and long-term treatment with the agent, using a wide range of doses, "is safe and well tolerated in children with asthma."

SOURCE: Annals of Allergy, Asthma and Immunology, July 2004.