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

Berger, William; Qaqundah, Paul Y.; Blake, Kathryn; Rodríguez‐Santana, José; Irani, Anne-Marie; Xu, John; Goldman, Mitchell

doi:10.1016/j.jpeds.2004.08.060

Cited by 30 publications

(19 citation statements)

References 12 publications

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“…Nine articles had abstracts and article text that accurately reflected the FDA clinical review and labeling change. Seven articles substantially differed in their presentation and interpretation of the data submitted to the FDA 11–17. In TABLE 3, the text from the labeling change (available at http://www.fda.gov/cder/pediatric/labelchange.htm) is shown alongside the abstract conclusions and relevant quotes from the article text.…”

Section: Resultsmentioning

confidence: 99%

Safety and Transparency of Pediatric Drug Trials

Benjamin

Smith²,

Sun³

et al. 2009

Arch Pediatr Adolesc Med

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Section: Resultsmentioning

confidence: 99%

Safety and Transparency of Pediatric Drug Trials

Benjamin

Smith²,

Sun³

et al. 2009

Arch Pediatr Adolesc Med

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“…Em relação aos estudos sobre a utilização de CI para o tratamento da sibilância em lactentes, existem diferenças nos critérios de seleção das crianças, nas estratégias de tratamento, na coleta dos dados e nos desfechos considerados 8,[13][14][15][16][17][18][19][20][21][22][23][24][25] . Apesar disso, é possível concluir que a utilização de CI em lactentes pode, em algumas situações, possibilitar um melhor controle dos sintomas que, porém, não se sustenta após a suspensão do mesmo, ou seja, não interfere A principal limitação do presente estudo compreende o fato de as frequências de uso de CO e CI serem estimadas pelo relato dos pais ou responsáveis pela criança e não através de registros médicos, o que seria mais confiável.…”

Section: Características N (%)unclassified

Oral and inhaled corticoid treatment for wheezing in the first year of life

Alvim¹,

Nunes²,

Fernandes³

et al. 2011

J Pediatr (Rio J)

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Objective: To evaluate the prevalence of corticoid utilization for the treatment of wheezing in infants less than 12 months old and to analyze factors associated with this practice.Methods: This was a cross-sectional study that administered the validated questionnaire from the International Study on the Prevalence of Wheezing in Infants to 1,261 infants aged 12 to 15 months in Belo Horizonte, Brazil. Proportions and 95% confidence intervals were calculated and the chi-square test was used to detect associations between variables.Results: Six hundred and fifty-six (52%) infants, 53% male and 48.2% white, exhibited wheezing during the first year of life. Mean age at first episode was 5.11±2.89 months. There was a high rate of morbidity, with many emergency visits (71%) and hospitalizations (27.8%). Also common were a family history of asthma and atopic disease (32.2 to 71%) and exposure to passive smoking (41.5%) and to mould (47.3%). The prevalence rates for corticoid use, whether via oral route (48.7%) or inhaled (51.3%), were elevated and were higher in the group that suffered three or more episodes. Children suffering greater morbidity were more likely to be prescribed a corticoid (p < 0.05). Conclusion:The high frequency of corticoid use highlights the need to establish specific criteria for the treatment of wheezing in the first years of life in order to avoid extrapolation of asthma treatments to other conditions that are transitory and self-limiting and in which using corticoids could involve more risk than benefit. J Pediatr (Rio J). 2011;87(4):314-318: Infant, asthma, treatment, morbidity. ResumoObjetivo: Avaliar a frequência e os fatores associados ao uso de corticoides para o tratamento de sibilância em lactentes no 1º ano de vida.Método: Estudo transversal, realizado com o questionário validado do Estudio Internacional de Sibilancias en Lactantes, com 1.261 lactentes entre 12 e 15 meses em Belo Horizonte (MG). Foi realizado o cálculo das proporções e intervalo de confiança de 95% e teste de qui-quadrado para estudo da associação entre as variáveis.Resultados: Seiscentos e cinquenta e seis (52%) manifestaram sibilância no 1º ano de vida, sendo 53% do sexo masculino e 48,2% brancos. A média de idade do primeiro episódio foi 5,11±2,89 meses. Verificou-se elevada morbidade, com frequentes idas à emergência (71%) e hospitalizações (27,8%). Foram frequentes a história familiar de asma e atopia (32,2 a 71%), exposição a tabagismo passivo (41,5%) e mofo (47,3%). As prevalências da utilização de corticoides, tanto por via oral (48,7%) quanto inalatória (51,3%), foram elevadas e maiores no grupo com três ou mais episódios. Crianças com maior morbidade tiveram maior chance de receber uma prescrição de corticoide (p < 0,05). Conclusão:A elevada frequência de utilização de corticoides aponta para a necessidade de estabelecerem-se critérios específicos para o tratamento da sibilância nos primeiro anos de vida, para evitar a extrapolação do tratamento da asma para outras condições transitórias e autolimitada...

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“…Interestingly, in the children using a mouthpiece for study drug, the highest prevalence of rash was in the placebo group (7.8%). (46) Finally, in a randomized, double-blind, 12-week study of 141 infants with asthma (aged 6-12 months), Berger et al (47) reported rash in 10.4% of infants taking BIS 0.5 mg/day, 0% taking BIS 1.0 mg/day, and 6.1% taking placebo. Thus while it is likely that some of the cutaneous events are due to facial deposition of BIS, there is no pattern that allows separation of those effects from other miscellaneous rashes, and no pattern that would implicate BIS as the cause of the rashes in general.…”

Section: Ics Delivered With a Mask Interfacementioning

confidence: 99%

“…The incidence of conjunctivitis with BIS is low in these studies, and similar to the comparator groups as well as to other studies using BUD Turbuhaler and placebo via mouthpiece. (34,45,47) At least in children it seems impossible to accurately measure the risk of cataracts or glaucoma from the available literature, either because the studies did not look specifically for these complications, or because the true incidence is so low that it would take thousands of subjects in a study to quantify the risk. However, with what is known about the relationship between corticosteroids and these eye diseases, it is hard to say that the risk is zero, particularly when there is direct eye exposure to the corticosteroid on a chronic basis.…”

Section: Ics Delivered With a Mask Interfacementioning

confidence: 99%

Clinical Side Effects during Aerosol Therapy: Cutaneous and Ocular Effects

Geller

2007

Journal of Aerosol Medicine

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Aerosolized medications maximize clinical benefit by targeting the airways and minimize side effects by reducing (though not eliminating) systemic exposure. Aerosolized drugs delivered with a facemask may inadvertently deposit on the face and in the eyes, raising concerns about cutaneous and ocular side effects with these drugs. Cases of anisocoria have been reported from exposure of the eyes to aerosol bronchodilators. Whether inhaled corticosteroids (ICS) can cause skin and eye problems like those seen with systemic or topical steroids is more difficult to answer. Patients who take ICS may have other corticosteroid exposures, or have other conditions that predispose them to side effects, making the analysis of the ICS risk challenging. Also, many studies were not designed to search for cutaneous or ocular effects, or may have been too short to detect these effects. Nevertheless, ICS have been associated with an increased risk of skin thinning, bruising, cataracts and possibly glaucoma in adults, but not in children. The risks increase with advanced age, higher doses, and longer duration of use. In children, the risks of cataracts and glaucoma were negligible with ICS, whether a mouthpiece or a mask interface was used. Side effects like skin rash and conjunctivitis occurred at low frequencies similar to placebo or comparator drugs. We do not know whether exposed children will have increased risks from ICS later in life. Therefore, it is wise to avoid face and eye deposition when possible, and to use the minimally effective dose.

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

Cited by 30 publications

References 12 publications

Safety and Transparency of Pediatric Drug Trials

Safety and Transparency of Pediatric Drug Trials

Oral and inhaled corticoid treatment for wheezing in the first year of life

Clinical Side Effects during Aerosol Therapy: Cutaneous and Ocular Effects

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