Original Article
Safety of budesonide inhalation suspension in infants aged six to twelve months with mild to moderate persistent asthma or recurrent wheeze

https://doi.org/10.1016/j.jpeds.2004.08.060Get rights and content

Objective

To compare the safety of budesonide inhalation suspension (BIS) with placebo in infants 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze.

Study design

In this multicenter, randomized, double-blinded, parallel-group, placebo-controlled study, 141 patients received 0.5 mg BIS (n = 48), 1.0 mg BIS (n = 44), or placebo (n = 49) once daily for 12 weeks. The primary variable was adrenal function, based on cosyntropin-stimulated plasma cortisol levels. Spontaneous adverse events and clinical laboratory findings also were monitored.

Results

Overall, the types and frequencies of adverse events reported during the study were comparable across treatment groups. The response to cosyntropin stimulation was similar across treatment groups, with no significant difference between BIS treatment and placebo.

Conclusions

The safety profile of BIS was similar to that of placebo, with no suppressive effect on adrenal function in patients 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze.

Section snippets

Patients

Enrolled patients were ≥6 but <12 months of age, with mild to moderate persistent asthma. Patients with ≥2 episodes of persistent or recurrent wheeze who might have benefited from inhaled anti-inflammatory treatment also were enrolled at the investigators' discretion. Patients with severe asthma, a history of assisted ventilation (except at birth), or other severe chronic lung diseases were excluded. Exclusion criteria also included treatment with systemic corticosteroids within 4 weeks of

Patient demographic and baseline characteristics

Of the 216 patients enrolled in the study, 141 were randomly assigned to treatment (Table I). Patient mean age was 8.4 months. With the exception of a higher percentage of boys than girls 9 to 12 months of age in the 0.5-mg BIS group (82% vs 18%, respectively), patient demographics were similar across treatment groups and age strata. Plasma cortisol levels were comparable across treatment groups (Table I) and age strata (data not shown). Of the 141 patients randomly assigned to treatment, 117

Discussion

The primary purpose of this 12-week study was to collect additional safety data for nebulized BIS in a patient population that is underrepresented in clinical trials of ICS. Adrenal function, the primary variable, was assessed in children with asthma 6 to 12 months of age, based on changes in cosyntropin-stimulated plasma cortisol levels. The cosyntropin-stimulation test is considered an adequate measure of adrenal function.9

Consistent with previously reported studies showing no effect of

References (13)

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Supported by AstraZeneca LP, Wilmington, Delaware.

Dr Berger receives research grants from AstraZeneca, GlaxoSmithKline, Aventis, and Schering-Plough; he is on the speaker's bureau for AstraZeneca, GlaxoSmithKline, Aventis, and Schering-Plough. Dr Blake receives research grants from AstraZeneca, GlaxoSmithKline, Merck, and Schering-Plough; she is on the speaker's bureau for AstraZeneca, GlaxoSmithKline, and Merck. Dr Irani receives research grants from AstraZeneca; she is a paid consultant and on the speaker's bureau for AstraZeneca. Dr Rodriguez-Santana has no interest or financial arrangement, including grants, advisory board memberships, or share holdings, with AstraZeneca. Dr Qaqundah has no potential, perceived, or real conflict of interest with the company that produces budesonide inhalation suspension (AstraZeneca).

Each author contributed equally to the preparation and review of this manuscript.

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