Background: It is widely recommended that children younger than five years who have persistent asthma be treated with low-dose inhaled corticosteroids delivered via metered-dose inhaler with a spacer device and face mask. Fluticasone (Flovent) is commonly used in this population, although few data are available on the safety or effectiveness of its use with hydrofluoroalkane (HFA), which recently replaced chlorofluorocarbon as the propellant in metered-dose inhalers. Many physicians prescribe fluticasone with HFA to control asthma symptoms in preschool-age children, although in the United States it is currently approved only for children four years and older. Qaqundah and colleagues evaluated the effectiveness of fluticasone with HFA in children younger than four years.

The Study: This placebo-controlled, randomized, double-blind trial included children one to three years of age with a history of symptomatic asthma. Participants experienced at least two asthma exacerbations requiring medical treatment within the previous year and needed short-acting beta agonists at least three times a week during the four weeks before the study. Exclusion criteria were receiving low-dose inhaled corticosteroids within the previous two weeks, moderate- or high-dose inhaled corticosteroids within the previous eight weeks, or systemic corticosteroids within the previous 10 weeks. Those with unresolved respiratory tract infections also were excluded.

The 359 participants were randomly selected to receive fluticasone or placebo. The fluticasone group received 88 mcg of fluticasone with HFA propellant twice a day, and the placebo group only received the HFA propellant. Both treatments were delivered via metered-dose inhaler attached to a spacer device with a face mask. Participants were standardized to receive nebulized albuterol (Proventil) as their short-acting beta agonist but were allowed to continue other previously prescribed noninhaled corticosteroid asthma medications (e.g., cromolyn [Intal], leukotriene modifiers, long-acting beta agonists).

Parents recorded the severity of their child's asthma symptoms and the use of albuterol and the study medication. Urine cortisol levels were measured at the beginning and end of the study. Patient progress was assessed during office visits at weeks 2, 4, 8, and 12. The main outcome was improvement in asthma symptom scores from baseline.

Results: Children in the treatment group had a 10 percent greater improvement in 24-hour asthma symptom scores than the placebo group, a significant difference. Nighttime symptom scores were significantly improved in the treatment group. A nonsignificant trend toward decreased albuterol use and daytime symptom scores was also noted in the treatment group. Although the number of symptom-free days was equal in both groups, 12 percent of the placebo group discontinued the study because of asthma exacerbation, compared with 5 percent of the treatment group. The number of adverse events was similar between the two groups. Although the overnight urine cortisol levels in the treatment group decreased by a mean of 0.5 mcg, no clinically significant systemic effects were noted.

Conclusion: The authors conclude that fluticasone with HFA delivered via metered-dose inhaler was well tolerated and effective for managing asthma in children one to three years of age.