Original ArticleSafety of budesonide inhalation suspension in infants aged six to twelve months 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)
- et al.
Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma
J Allergy Clin Immunol
(1998) - et al.
Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children
Ann Allergy Asthma Immunol
(1999) - et al.
Effects of budesonide inhalation suspension on hypothalamic-pituitary-adrenal–axis function in infants and young children with persistent asthma
Ann Allergy Asthma Immunol
(2002) - et al.
Safety profile of budesonide inhalation suspension in the pediatric population: worldwide experience
Ann Allergy Asthma Immunol
(2004) Study designs and challenges in clinical studies conducted in infants and children with asthma
J Allergy Clin Immunol
(1999)Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics: 2002
J Allergy Clin Immunol
(2002)
Cited by (30)
The safety of long-term use of inhaled corticosteroids in patients with asthma: A systematic review and meta-analysis
2022, Clinical ImmunologyCitation Excerpt :The P value of Begg's rank correlation test (STATA 12.0) was used to assess the presence of publication bias in included articles for each outcome. Of 17,234 trials recognized by the initial search, 331 were retrieved for more detailed assessment, and 86 trials [8–91,105–107] were included in the meta-analysis (Fig. 1). Baseline characteristics of trials included in the meta-analysis are shown in Table 1.
Aerosol delivery of nebulised budesonide in young children with asthma
2009, Respiratory MedicineCitation Excerpt :These studies have included a wide age range of children and have not looked at the efficiency in young children (infants and preschool children) separately and may therefore not be valid for this specific age group. There is only one study looking at the safety of 0.5 mg and 1.0 mg of larger particle sized nebulised budesonide in infants.38 Whereas the authors have shown these doses to be safe, they could not find a significant difference in symptom free days and the global assessment of patient health.
When and why begin inhaled corticosteroid therapy in the wheezy infant
2009, Revue Francaise d'AllergologieWhat's new in pediatric allergology in 2005? Part 3. Respiratory allergy: pathophysiology, diagnosis, prevention and treatment (A review of the international literature from October 2004 to October 2005)
2006, Revue Francaise d'Allergologie et d'Immunologie CliniqueInhaled corticosteroids for infants [3]
2006, Journal of PediatricsReply [4]
2006, Journal of Pediatrics
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.