Resolution of T Cell Lymphopenia in a Term Infant with Absent TRECs on Newborn Screen

Abstract

RATIONALE: One-year studies showed that older ICS and many INCS caused a ;1cm growth effect in children with asthma and allergic rhinitis, respectively. However, there are no data on the growth effects of the concomitant use of ICS and INCS, which is very common in clinical practice. METHODS: Single-center, randomized, placebo-controlled, 3-period cross-over study to evaluate the effect of: 1) Omnaris Nasal Spray 200 mg QD and Alvesco Inhalation Aerosol 80 mg BID (O/A); versus 2) Beconase AQ Nasal Spray 168 mg BID and QVAR Inhalation Aerosol 40 mg BID (B/Q); versus 3) Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID (P/P) on short term growth (knemometry) and HPA axis function (12 hour overnight urinary cortisol) in 22 pediatric subjects (6-15 years) with asthma and allergic rhinitis. Each treatment and washout period lasted 3 weeks. RESULTS: Growth velocity in mm/week (mean, 95% CI) was 0.23 (0.04-0.41) for O/A (p5 0.033 versus P/P), 0.33 (0.14-0.51) for B/Q (p50.16 versus P/P), and 0.51 (0.32-0.70) for P/P. The respective values for HPA axis function (mean cortisol/creatinine mg/mg, 95% CI) were 0.10 (0.05-0.15), 0.11 (0.06-0.16), and 0.14 (0.09-0.19) (p>0.05). CONCLUSIONS: Combining an INCS with an ICS, even one which alone had no growth effect in a robust 1-year study (Alvesco), produced a detectable signal of systemic steroid activity. Surprisingly, B/Q did not affect growth. More studies, including durations of 1-year and multiple years, need to be done to identify the true level of risk of concomitant therapy with ICS and INCS in children.