Table 4.
Summary of systemic AEs in clinical trials of INS
| Author/year | N | INS Treatment regimen | Treatment duration | Patient population | Growth retardation/HPA axis (test) |
|---|---|---|---|---|---|
| Acute rhinosinusitis | |||||
| Nayak et al [62] | 967 | MF 200 or 400 μg BID | 21 d | Children and adults (8–78 y) | No decreases in cortisol (cosyntropin stimulation) |
| Chronic rhinosinusitis | |||||
| Giger et al [61] | 112 | BDP 400 μg QD or BID (no PBO arm) | 12 wk | Adults (19–66 y) | Minimal decrease in morning serum cortisol levels |
| Allergic rhinitis | |||||
| Pipkorn et al [64] | 24 | BUD 200–400 μg BID | Up to 5.5 y | Adolescents and adults (17–67 y) | No decreases in cortisol (ACTH challenge) |
| Grossman et al [67] | 250 | FP 100 or 200 μg QD | 14 d | Children (4–11 y) | No effect on morning cortisol levels |
| Brannan et al [69] | 96 | MF 50, 100, or 200 μg QD | 7 or 14 d | Children (3–12 y) | No effect on cortisol (cosyntropin stimulation in children aged 3–5 y only) |
| Nayak et al [68] | 80 | TAA 220 or 400 μg QD | 42 d | Children (6–12 y) | No effect on cortisol (cosyntropin stimulation) |
| Healthy subjects | |||||
| Wihl et al [63] | 14 | BUD or BDP 200, 400, and 800 μg QD | 3 wk | Men (18–47 y) | No significant influence on plasma cortisol, significant decrease in urinary cortisol with BUD 400 and 800 μg |
| 32 | BUD or BDP 100, 200, and 400 μg BID | 4 d | Men (19–41 y) | Significant reductions in urinary cortisol with all BUD doses and BDP 400 μg | |
| Allergic rhinitis | |||||
| Vargas et al [66] | 105 | FP 200 mcg QD or 400 μg BID; | 28 d | Adults (18–65 y) | [FP] No effect on cortisol (cosyntropin stimulation) |
| OR | [P] Significant reduction (P < .05) in cortisol (cosyntropin stimulation and morning urinary levels) | ||||
| Oral prednisone 7.5 or 15 mg QD | |||||
| Agertoft and Pederson [71]⁎ | 22 | MF 100 or 200 μg QD OR | 2 wk before crossover | Children (7–12 y) | No short-term effect on growth rate (knemometry) |
| BUD 400 μg QD | |||||
| Wolthers and Pedersen [53] | 44 | BUD 200 μg BID (n=14) vs IM methylprednisolone acetate (n=14) vs. terfenadine (n=16) | 6 wk | Children (6–15 y) | Suppressed short-term lower-leg growth with BUD and depot steroid (knemometry) |
| Schenkel et al [50] | 98 | MF 100 μg QD | 1 y | Children (3–9 y) | No effect on cortisol (cosyntropin stimulation) or growth rate (knemometry) |
| Allergic rhinitis | |||||
| Skoner et al [51] | 100 | BDP 168 μg BID | 1 y | Children (6–9 y) | No effect on morning cortisol levels or response to cosyntropin stimulation/growth suppression (stadiometry) |
| Allen et al [70] | 150 | FP 200 μg QD | 1 y | Children (3.5–9 y) | No growth changes |
| Kim et al [26] | 78 | BUD 64 μg QD | 42 d | Children (2–5 y) | No decreases in cortisol (cosyntropin stimulation) |
P indicates prednisone; PBO, placebo.
⁎
Four-way crossover study (results show no sequence or carryover effects).