Document Detail


Inhaled growth hormone (GH) compared with subcutaneous GH in children with GH deficiency: pharmacokinetics, pharmacodynamics, and safety.
MedLine Citation:
PMID:  19336514     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Delivery of GH via inhalation is a potential alternative to injection. Previous studies of inhaled GH in adults have demonstrated safety and tolerability.
OBJECTIVE: We sought to assess safety and tolerability of inhaled GH in children and to estimate relative bioavailability and biopotency between inhaled GH and sc GH.
DESIGN/METHODS: This pediatric multicenter, randomized, double-blind, placebo-controlled, crossover trial had two 7-d treatment phases. Patients received inhaled GH and sc GH in the alternate phase. Placebo was administered by the route opposite from active drug. GH and IGF-I levels were measured at multiple time points. Pharmacokinetics were assessed using noncompartmental methods.
RESULTS: Twenty-two GH-deficient children aged 6-16 yr were treated. Absorption of GH appeared to be faster after inhalation with maximum serum concentrations measured at 1-4 h compared with 2-8 h for sc GH. Mean relative bioavailability for inhaled GH was 3.5% (90% confidence interval 2.7-4.4%). Mean relative biopotency, based on IGF-I response, was 5.5% (confidence interval 5.2-5.8%). Similar dose-dependent increases in mean serum GH area under the curve and IGF-I changes from baseline were seen after inhaled and sc GH doses. Inhaled GH was well tolerated and preferred to injection. No significant changes in pulmonary function tests were seen.
CONCLUSIONS: In this first pediatric trial of GH delivered by inhalation, it was well tolerated and resulted in dose-dependent increases in serum GH and IGF-I levels. This study establishes that delivery of GH via the deep lung is feasible in children.
Authors:
Emily C Walvoord; Amparo de la Peña; Soomin Park; Bernard Silverman; Leona Cuttler; Susan R Rose; Gordon Cutler; Stenvert Drop; John J Chipman
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2009-03-31
Journal Detail:
Title:  The Journal of clinical endocrinology and metabolism     Volume:  94     ISSN:  1945-7197     ISO Abbreviation:  J. Clin. Endocrinol. Metab.     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-04     Completed Date:  2009-07-02     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  0375362     Medline TA:  J Clin Endocrinol Metab     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2052-9     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Administration, Cutaneous
Administration, Inhalation
Adolescent
Child
Cross-Over Studies
Dose-Response Relationship, Drug
Double-Blind Method
Female
Follow-Up Studies
Growth Disorders / blood,  drug therapy*
Human Growth Hormone / administration & dosage*,  adverse effects*,  deficiency,  pharmacokinetics*
Humans
Male
Patient Satisfaction
Placebos
Chemical
Reg. No./Substance:
0/Placebos; 12629-01-5/Human Growth Hormone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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