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. Author manuscript; available in PMC: 2015 Jun 14.
Published in final edited form as: Cochrane Database Syst Rev. 2013 Jun 5;6:CD008901. doi: 10.1002/14651858.CD008901.pub2

Characteristics of ongoing studies [ordered by study ID]

Hardin 2008
Trial name or title Phase II Study of Growth Hormone in Children With Cystic Fibrosis
Methods Randomised, multicentre cross-over study.
(2 periods of 1 year each).
Participants Inclusion criteria

  • ages 5–12 years

  • diagnosis of pre-pubertal CF

  • height and weight < 25th percentile

  • no colonization with B. cepacia

  • capable of performing pulmonary function tests


Exclusion criteria

  • prior or concurrent insulin therapy

  • haematologic, hepatic, renal disease
Interventions Intervention: daily SC injections of rhGH.
Control: no treatment.
Outcomes Primary outcomes

  • pulmonary function tests

  • nutritional parameters: height, weight, height velocity, lean body mass


Secondary outcome:

  • QoL
Starting date 2001
Contact information Dana Hardin, MD, Southwest Medical Center at Dallas
Notes
Lippe 2008
Trial name or title A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis
Methods Multicentre, randomised controlled, open-label study
Participants Inclusion criteria

  • ages 5–13 years

  • established diagnosis of CF

  • able to perform pulmonary function test

  • height < 10th percentile

  • prepubertal, Tanner stage 1

  • bone age ≤ 10 years for girls, ≤11 years for boys

  • adequate caloric intake


Exclusion criteria

  • prior or current rhGH use

  • glucose intolerance or CFRD

  • Infection with B. cepacia

  • disease exacerbation in 14 days prior to the study

  • active neoplasia
Interventions Daily SC injection of rhGH (Nutropin AQ®)
Outcomes Primary outcomes

  • safety and efficacy of Nutropin AQ® in those with CF

  • change in lean body mass in those with CF


Secondary outcomes

  • pulmonary function tests

  • disease related exacerbation

  • exercise capacity
Starting date 2003
Contact information Barbara Lippe, MD, Genentech Inc.
Notes This study has been completed. No published data available yet

B. cepacia: Burkholderia cepacia

CF: cystic fibrosis

CFRD: cystic fibrosis-related diabetes

FEV1: forced expiratory volume in one second

QoL: quality of life

rhGH: recombinant human growth hormone

SC: subcutaneous