Randomized placebo-controlled trial comparing fluticasone aqueous nasal spray in mono-therapy, fluticasone plus cetirizine, fluticasone plus montelukast and cetirizine plus montelukast for seasonal allergic rhinitis

Authors

  • G. Di Lorenzo,

  • M. L. Pacor,

  • M. E. Pellitteri,

  • G. Morici,

  • A. Di Gregoli,

  • C. Lo Bianco,

  • V. Ditta,

  • N. Martinelli,

  • G. Candore,

  • P. Mansueto,

  • G. B. Rini,

  • R. Corrocher,

  • C. Caruso


In [1], an incorrect version of Table 2 was published on page 264. The correct table is displayed below.

Table 2.   Mean values for FPANS, FPANS plus CTZ, FPANS plus MSK, CTZ plus MSK and PLA (95%CI for mean) and mean differences between the treatments for total symptom score (out of 12), nasal blockage on waking (out of 3) and daily (out of 3), rhinorrhoea (out of 3), sneezing (out of 3) and nasal itching (out of 3).
TreatmentsTSSNasal congestion
on waking
Nasal congestion
daily
RhinorrhoeaSneezingNasal itching
  1. FPANS, fluticasone propionate aqueous nasal spray; CTZ, ceterizine; MSK, montelukast; PLA, placebo; TSS, total symptom score; NS, not significant.

 Subjective symptoms of rhinitis
 Mean (95%CI)
FPANS3.0 (2.8–3.1)0.8 (0.7–0.9)0.9 (0.8–0.9)0.5 (0.5–0.6)0.9 (0.8–0.9)0.6 (0.5–0.7)
FPANS plus CTZ2.8 (2.6–2.9)0.7 (0.7–0.8)0.8 (0.8–0.9)0.6 (0.5–0.6)0.8 (0.7–0.8)0.5 (0.4–0.5)
FPANS plus MSK3.0 (2.8–3.1)0.7 (0.7–0.8)0.8 (0.8–0.9)0.6 (0.5–0.6)0.8 (0.8–0.9)0.6 (0.6–0.7)
CTZ plus MSK3.3 (3.1–3.5)1.2 (1.2–1.3)1.2 (1.2–1.3)0.5 (0.5–0.6)0.8 (0.7–0.9)0.6 (0.6–0.7)
PLA4.7 (4.5–4.9)1.3 (1.2–1.3)1.2 (1.1–1.3)1.3 (1.2–1.3)1.1 (1.1–1.2)0.9 (0.8–0.9)
 Comparisons
 Mean differences between the treatments (95%CI for difference)
Differences FPANS vs. PLA−1.6−0.5−0.3−0.7−0.3−0.2
(−1.8 to −1.4)(−0.5 to −0.4)(−0.4 to −0.3)(−0.7 to 0.6)(−0.3 to −0.2)(−0.3 to −0.1)
P<0.001P<0.001P<0.001P<0.001P<0.001P<0.001
Differences FPANS vs. FPANS plus CTZ0.20.060.04−0.040.080.1
(0.08 to −0.4)(−0.01 to 0.1)(−0.03 to 0.1)(−0.88 to 0.006)(−0.008 to 0.1)(0.06 to 0.2)
P=0.04P=NSP=NSP=NSP=NSP=0.003
Differences FPANS vs. FPANS plus MSK0.020.050.04−0.020.02−0.02
(−0.1 to 0.2)(−0.02 to 0.1)(−0.03 to 0.1)(−0.06 to 0.02)(−0.04 to 0.1)(−0.09 to 0.05)
P=NSP=NSP=NSP=NSP=NSP=NS
Difference FPANS vs. CTZ plus MSK−0.3−0.4−0.30.020.040.002
(−0.5 to −0.07)(−0.5 to −0.3)(−0.4 to −0.2)(−0.01 to 0.07)(−0.03 to 0.1)(−0.07 to 0.07)
P=0.009P<0.001P<0.001P=NSP=NSP=NS
Diffrences FPANS plus CTZ vs. PLA−1.8−0.5−0.4−0.6−0.3−0.4
(−2.1 to −1.6)(−0.6 to −0.4)(−0.4 to −0.3)(−0.7 to 0.6)(−0.4 to −0.3)(−0.4 to −0.3)
P<0.001P<0.001P<0.001P<0.001P<0.001P<0.001
Difference FPANS plus CTZ vs. FPANS plus MSK−0.1−0.005−0.00010.01−0.05−0.1
(−0.4 to 0.01)(−0.08 to 0.06)(−0.07 to 0.07)(−0.02 to 0.06)(−0.1 to 0.01)(−0.2 to −0.08)
P=NSP=NSP=NSP=NSP=NSP<0.001
Difference FPANS plus CTZ vs. CTZ plus MSK−0.5−0.5−0.40.07−0.04−0.1
(−0.7 to −0.2)(−0.6 to −0.4)(−0.4 to −0.3)(0.02 to 0.1)(−0.1 to 0.03)(−0.2 to −0.06)
P<0.001P<0.001P<0.001P=0.04P=NSP=0.003
Difference FPANS plus MSK vs. PLA−1.6−0.5−0.4−0.7−0.3−0.2
(−1.9 to −1.4)(−0.6 to −0.4)(−0.5 to −0.3)(0.7 to −0.6)(−0.3 to −0.2)(−0.3 to −0.1)
P<0.001P<0.001P<0.001P<0.001P<0.001P<0.001
Difference FPANS plus MSK vs. CTZ plus MSK−0.3−0.5−0.30.050.010.02
(−0.5 to −0.09)(−0.7 to −0.2)(−0.5 to −0.4)(0.003 to 0.09)(−0.06 to 0.08)(−0.05 to 0.09)
P=0.005P<0.001P<0.001P=NSP=NSP=NS
Difference CTZ plus MSK vs. PLA−1.3−0.03−0.02−0.7−0.3−0.2
(−1.5 to −1.1)(−0.1 to 0.04)(−0.09 to 0.04)(0.8 to −0.7)(−0.4 to −0.2)(−0.3 to −0.1)
P<0.001P=NSP=NSP<0.001P<0.001P<0.001

Ancillary