BACKGROUND: The effect on linear growth of daily long-term inhaled corticosteroid therapy in preschool-aged children with recurrent wheezing is controversial. OBJECTIVE: We sought to determine the effect of daily inhaled corticosteroid given for 2 years on linear growth in preschool children with recurrent wheezing. METHODS:Children aged 2 and 3 years with recurrent wheezing and positive modified Asthma Predictive Index scores were randomized to a 2-year treatment period of chlorofluorocarbon-delivered fluticasone propionate (176 μg/d) or masked placebo delivered through a valved chamber with a mask and then followed for 2 years off study medication. Height growth determined by means of stadiometry was compared between treatment groups. RESULTS: In the study cohort as a whole, the fluticasone group did not have significantly less linear growth than the placebo group (change in height from baseline difference, -0.2 cm; 95% CI, -1.1 to 0.6) 2 years after discontinuation of study treatment. In post hoc analyses children 2 years old who weighed less than 15 kg at enrollment and were treated with fluticasone had less linear growth compared with those treated with placebo (change in height from baseline difference, -1.6 cm; 95% CI, -2.8 to -0.4; P = .009). CONCLUSION:Linear growth was not significantly different in high-risk preschool-aged children with recurrent wheezing treated with 176 μg/dchlorofluorocarbon-delivered fluticasone compared with placebo 2 years after fluticasone is discontinued. However, post hoc subgroup analyses revealed that children who are younger in age and of lesser weight relative to the entire study cohort had significantly less linear growth, possibly because of a higher relative fluticasone exposure.
RCT Entities:
BACKGROUND: The effect on linear growth of daily long-term inhaled corticosteroid therapy in preschool-aged children with recurrent wheezing is controversial. OBJECTIVE: We sought to determine the effect of daily inhaled corticosteroid given for 2 years on linear growth in preschool children with recurrent wheezing. METHODS:Children aged 2 and 3 years with recurrent wheezing and positive modified Asthma Predictive Index scores were randomized to a 2-year treatment period of chlorofluorocarbon-delivered fluticasone propionate (176 μg/d) or masked placebo delivered through a valved chamber with a mask and then followed for 2 years off study medication. Height growth determined by means of stadiometry was compared between treatment groups. RESULTS: In the study cohort as a whole, the fluticasone group did not have significantly less linear growth than the placebo group (change in height from baseline difference, -0.2 cm; 95% CI, -1.1 to 0.6) 2 years after discontinuation of study treatment. In post hoc analyses children 2 years old who weighed less than 15 kg at enrollment and were treated with fluticasone had less linear growth compared with those treated with placebo (change in height from baseline difference, -1.6 cm; 95% CI, -2.8 to -0.4; P = .009). CONCLUSION: Linear growth was not significantly different in high-risk preschool-aged children with recurrent wheezing treated with 176 μg/d chlorofluorocarbon-delivered fluticasone compared with placebo 2 years after fluticasone is discontinued. However, post hoc subgroup analyses revealed that children who are younger in age and of lesser weight relative to the entire study cohort had significantly less linear growth, possibly because of a higher relative fluticasone exposure.
Authors: Stanley Szefler; Scott Weiss; James Tonascia; N Franklin Adkinson; Bruce Bender; Reuben Cherniack; Michele Donithan; H William Kelly; Joseph Reisman; Gail G Shapiro; Alice L Sternberg; Robert Strunk; Virginia Taggart; Mark Van Natta; Robert Wise; Margaret Wu; Robert Zeiger Journal: N Engl J Med Date: 2000-10-12 Impact factor: 91.245
Authors: Theresa W Guilbert; Wayne J Morgan; Marzena Krawiec; Robert F Lemanske; Chris Sorkness; Stanley J Szefler; Gary Larsen; Joseph D Spahn; Robert S Zeiger; Gregory Heldt; Robert C Strunk; Leonard B Bacharier; Gordon R Bloomberg; Vernon M Chinchilli; Susan J Boehmer; Elizabeth A Mauger; David T Mauger; Lynn M Taussig; Fernando D Martinez Journal: Control Clin Trials Date: 2004-06
Authors: D P Skoner; S J Szefler; M Welch; K Walton-Bowen; M Cruz-Rivera; J A Smith Journal: J Allergy Clin Immunol Date: 2000-02 Impact factor: 10.793
Authors: R J Kuczmarski; C L Ogden; L M Grummer-Strawn; K M Flegal; S S Guo; R Wei; Z Mei; L R Curtin; A F Roche; C L Johnson Journal: Adv Data Date: 2000-06-08
Authors: Theresa W Guilbert; Wayne J Morgan; Robert S Zeiger; Leonard B Bacharier; Susan J Boehmer; Marzena Krawiec; Gary Larsen; Robert F Lemanske; Andrew Liu; David T Mauger; Chris Sorkness; Stanley J Szefler; Robert C Strunk; Lynn M Taussig; Fernando D Martinez Journal: J Allergy Clin Immunol Date: 2004-12 Impact factor: 10.793
Authors: Hans Bisgaard; David Allen; Janusz Milanowski; Ilia Kalev; Lisa Willits; Patricia Davies Journal: Pediatrics Date: 2004-02 Impact factor: 7.124
Authors: N G Papadopoulos; H Arakawa; K-H Carlsen; A Custovic; J Gern; R Lemanske; P Le Souef; M Mäkelä; G Roberts; G Wong; H Zar; C A Akdis; L B Bacharier; E Baraldi; H P van Bever; J de Blic; A Boner; W Burks; T B Casale; J A Castro-Rodriguez; Y Z Chen; Y M El-Gamal; M L Everard; T Frischer; M Geller; J Gereda; D Y Goh; T W Guilbert; G Hedlin; P W Heymann; S J Hong; E M Hossny; J L Huang; D J Jackson; J C de Jongste; O Kalayci; N Aït-Khaled; S Kling; P Kuna; S Lau; D K Ledford; S I Lee; A H Liu; R F Lockey; K Lødrup-Carlsen; J Lötvall; A Morikawa; A Nieto; H Paramesh; R Pawankar; P Pohunek; J Pongracic; D Price; C Robertson; N Rosario; L J Rossenwasser; P D Sly; R Stein; S Stick; S Szefler; L M Taussig; E Valovirta; P Vichyanond; D Wallace; E Weinberg; G Wennergren; J Wildhaber; R S Zeiger Journal: Allergy Date: 2012-06-15 Impact factor: 13.146
Authors: Anne M Fitzpatrick; Daniel J Jackson; David T Mauger; Susan J Boehmer; Wanda Phipatanakul; William J Sheehan; James N Moy; Ian M Paul; Leonard B Bacharier; Michael D Cabana; Ronina Covar; Fernando Holguin; Robert F Lemanske; Fernando D Martinez; Jacqueline A Pongracic; Avraham Beigelman; Sachin N Baxi; Mindy Benson; Kathryn Blake; James F Chmiel; Cori L Daines; Michael O Daines; Jonathan M Gaffin; Deborah Ann Gentile; W Adam Gower; Elliot Israel; Harsha Vardhan Kumar; Jason E Lang; Stephen C Lazarus; John J Lima; Ngoc Ly; Jyothi Marbin; Wayne Morgan; Ross E Myers; J Tod Olin; Stephen P Peters; Hengameh H Raissy; Rachel G Robison; Kristie Ross; Christine A Sorkness; Shannon M Thyne; Stanley J Szefler Journal: J Allergy Clin Immunol Date: 2016-10-21 Impact factor: 10.793
Authors: Stanley J Szefler; James F Chmiel; Anne M Fitzpatrick; George Giacoia; Thomas P Green; Daniel J Jackson; Heber C Nielsen; Wanda Phipatanakul; Hengameh H Raissy Journal: J Allergy Clin Immunol Date: 2013-11-28 Impact factor: 10.793
Authors: Hengameh H Raissy; H William Kelly; Michelle Harkins; Stanley J Szefler Journal: Am J Respir Crit Care Med Date: 2013-04-15 Impact factor: 21.405