Short-term growth during treatment with inhaled fluticasone propionate and beclomethasone dipropionate.

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Abstract

Short-term lower leg growth was investigated with twice weekly knemometry measurements in 19 schoolchildren with mild asthma during treatment with daily doses of 200 micrograms fluticasone propionate, 400 micrograms, and 800 micrograms beclomethasone dipropionate from a dry powder inhaler. The design was a randomised, double blind, crossover trial. After a run in period of four days (period 1) the children were allocated to a sequence of active treatments in periods 2, 4, and 6. In periods 3 and 5 (wash out) placebo was given. All periods except the run in were two weeks long. The mean lower leg growth velocities during the wash out periods were 0.61 and 0.80 mm/week. Mean growth velocities during treatment with fluticasone propionate and low and high doses of beclomethasone dipropionate were 0.34, 0.09, and 0.06 mm/week respectively. Compared with fluticasone propionate, treatment with beclomethasone dipropionate 400 and 800 micrograms/day was associated with a statistically significant reduction in growth velocity.

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The human pharmacology of fluticasone propionate.

S. Harding (1990)

Fluticasone propionate is a potent, locally active glucocorticoid which has no demonstrable systemic side-effects when given by the oral or intranasal routes. The recommended clinical dose for rhinitis is 200 micrograms once a day intranasally or twice a day if symptoms persist. Four studies are described which establish the metabolic and pharmacokinetic features of fluticasone propionate and which assess the systemic effects of oral and intranasal doses in healthy volunteers. The drug was cleared rapidly by metabolism, with a total blood clearance equivalent to hepatic blood flow. On this basis, the expected extraction ratio would approach unity and oral systemic bioavailability would approach zero. This was confirmed by the absence of unchanged drug in the plasma up to 6 h after dosing with 1 mg or 16 mg of drug. The principal metabolite found, the 17-carboxylic acid derivative, has negligible glucocorticoid activity. This rapid clearance to an inactive metabolite is the basis for the observed lack of effects on the hypothalamo-pituitary-adrenal axis after single, night-time doses of fluticasone propionate, 16 mg orally, and after fluticasone propionate, 4 mg intranasally for 1 week. The virtually zero oral bioavailability and lack of systemic effects by the oral and intranasal routes are features which are unique compared with other glucocorticoids used clinically.

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Growth and childhood asthma.

Jennifer L Balfour (1986)

Height and weight were measured every six months in a long term prospective study of 66 children with chronic perennial asthma for a mean 13.1 years. There was no evidence of growth retardation on entry into the study. Growth developed along normal lines in all 66 children until about 10 years, and in 35 of these children growth continued along normal lines throughout the whole period of follow up. Thirty children showed the physiological decelerating growth velocity pattern seen in children with delay in the onset of puberty, and one child had an early menarche. The tendency for delay in the onset of puberty was significant for both boys and girls and was noted to be independent of severity of asthma. Once puberty finally began in these children, complete catch up growth resulted in the attainment of the predicted adult height. Long term prophylactic inhalation of beclomethasone dipropionate in 26 children in a dosage up to 600 mcg/day before puberty and 400 mcg/day during puberty was shown not to affect growth. It is concluded that asthma had no direct influence on growth in height but was associated with delay in the onset of puberty. The pre-adolescent physiological deceleration of growth velocity that occurs in these children gives the impression of growth retardation.

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Maturational delay and temporal growth retardation in asthmatic boys.

C Susanne, R Hauspie, Jenolyn Alexander (1977)

Growth in height, bone age, and sexual maturation have been studied in asthmatic boys 2 to 20 yr of age. The mean pattern of growth in height has been analyzed mixed-longitudinally in 531 patients (1,754 measures) and seemed to be determined by a delay in physiologic maturation. The asthmatic boys' growth in height showed no retardation during infancy, a small but consistent retardation during childhood, a more pronounced delay at adolescence, and a catch-up growth toward adulthood. The mean adolescent growth spurt is delayed by about 1.3 yr. Bone age has been analyzed mixed-longitudinally in a subsample of 370 patients (660 observations) and showed a slight retardation at all ages between 6 and 13 yr. Development of pubic hair of 91 subjects analyzed cross-sectionally was definitely retarded when compared to adequate reference data. Evidence was given that factors secondary to the asthmatic syndrome are involved in the retardation of growth and development.