Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study

Becker, Allan B.; Kuznetsova, Olga M.; Vermeulen, Jan; Soto-Quirós, Manuel E.; Young, Betty W; Reiss, Theodore F.; Dass, Sairia; Knorr, Barbara

doi:10.1016/s1081-1206(10)61342-7

Cited by 62 publications

(35 citation statements)

References 24 publications

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“…In the montelukast growth study, children with mild persistent asthma were randomly placed on montelukast, BDP, or placebo, and it was observed that the mean growth velocity was slower in the BDP group than either the placebo or montelukast groups (56). No effect on pulmonary function was noted in this investigation.…”

Section: Newer Versus Older Inhaled Corticosteroidsmentioning

confidence: 63%

Safety and Efficacy of Inhaled Corticosteroids (ICS) in Children with Asthma

Petrisko

Skoner

2008

Journal of Asthma

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Inhaled corticosteroids (ICS) are the guideline-preferred preventative therapy for persistent asthma of all severity levels and for all ages, including children. While these drugs are unquestionably efficacious, concerns of adverse systemic effects limit patient compliance with treatment regimens and thus the attainable benefits. Suppression of bone growth, bone density, and HPA axis function, in addition to cataract formation and elevated intraocular pressure/glaucoma, have been associated with ICS use. This review will focus on recent developments in the safety and efficacy of ICS as compared to oral CS corticosteroids and the achievement of a balance between risk and benefit in optimizing ICS therapy.

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Section: Newer Versus Older Inhaled Corticosteroidsmentioning

confidence: 63%

Safety and Efficacy of Inhaled Corticosteroids (ICS) in Children with Asthma

Petrisko

Skoner

2008

Journal of Asthma

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“…The results showed that linear growth velocity in the beclomethasone group was significantly less than in the placebo group (difference = -0.78 cm/year; p < 0.001) or the montelukast group (0.81 cm/year; p < 0.001). The growth rate was similar for both montelukast and placebo [144]. One recent study assessed the influence of montelukast on shortterm lower leg growth rate (LLGR) in 71 prepubertal children with asthma.…”

Section: Children (Aged 6-14 Years)mentioning

confidence: 96%

Montelukast in the treatment of asthma and beyond

Diamant¹,

Mantzouranis

Bjermer

2009

Expert Review of Clinical Immunology

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“…8 Previous studies conforming to these criteria have been conducted in patients with asthma treated with orally inhaled corticosteroids. [9][10][11] Although studies with TAA-AQ in children with AR have examined its efficacy and safety 12 as well as GV, 13,14 the long-term effect of TAA-AQ on growth has not been assessed in randomized controlled trials. This study, designed per the FDA guidance recommendations, evaluates the difference in the GV of children aged 3-9 years with PAR treated with intranasal TAA-AQ or placebo for 12 months.…”

Section: What This Study Addsmentioning

confidence: 99%

Intranasal Triamcinolone and Growth Velocity

et al. 2015

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BACKGROUND: Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR).METHODS: This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 mg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months). Hypothalamus-pituitary-adrenal (HPA) axis function was assessed by measuring urinary cortisol levels. Details of adverse events were recorded.RESULTS: Of 1078 subjects screened, 299 were randomized, and 216 completed the study (placebo, 107; TAA-AQ, 109). In the primary analysis (modified intent-to-treat: placebo, 133; TAA-AQ, 134), least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) versus placebo (6.09 cm/year). The difference (-0.45 cm/year; 95% confidence interval: -0.78 to -0.11; P = .01), although clinically nonsignificant, was evident within 2 months of treatment and stabilized thereafter. At follow-up, the GV approached baseline (6.70 cm/year) in the TAA-AQ group (6.59 cm/year) and decreased slightly in the placebo group (5.89 cm/year vs 6.06 cm/year at baseline). No HPA axis suppression was observed.CONCLUSIONS: By using rigorous Food and Drug Administration-recommended design elements, this study detected a small, statistically significant effect of TAA-AQ on the GV of children with PAR.

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Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study

Cited by 62 publications

References 24 publications

Safety and Efficacy of Inhaled Corticosteroids (ICS) in Children with Asthma

Safety and Efficacy of Inhaled Corticosteroids (ICS) in Children with Asthma

Montelukast in the treatment of asthma and beyond

Intranasal Triamcinolone and Growth Velocity

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