Methods: Single-center, randomized, placebo-controlled, 3-period cross-over study to evaluate the effect of: 1) Omnaris Nasal Spray 200 µg QD and Alvesco Inhalation Aerosol 80 µg BID (O/A); versus 2) Beconase AQ Nasal Spray 168 µg BID and QVAR Inhalation Aerosol 40 µg 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 (p= 0.033 versus P/P), 0.33 (0.14-0.51) for B/Q (p=0.16 versus P/P), and 0.51 (0.32-0.70) for P/P. The respective values for HPA axis function (mean cortisol/creatinine µg/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.