Table 2 Mean change from baseline in daily rTNSS over the first 2 and 4 weeks of treatment (ITT population).

From: Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study

Daily rTNSS

All patientsc

≥2 to ≤6 yearsd

>6 to ≤12 yearsd

FFNS 55 µg once daily (n = 119)

FFNS 110 µg once daily (n = 119)

FFNS 55/110 µg once daily (n = 238)

Placebo (n = 120)

FFNS 55 µg once daily (n = 59)

FFNS 110 µg once daily (n = 60)

FFNS 55/110 µg once daily (n = 119)

Placebo (n = 60)

FFNS 55 µg once daily (n = 60)

FFNS 110 µg once daily (n = 59)

FFNS 55/110 µg once daily (n = 119)

Placebo (n = 60)

Baseline mean (SD)

8.4 (1.46)

8.3 (1.25)

8.4 (1.36)

8.5 (1.44)

        

Week 1–2 mean (SD)

5.2 (1.94)

5.1 (2.10)

5.2 (2.02)

6.5 (1.72)

        

Week 1–4 mean (SD)

4.5 (1.94)

4.4 (2.08)

4.4 (2.01)

5.9 (1.79)

        

Week 1–2 change from baseline

  Mean change (SD)

−3.2 (1.95)

−3.2 (1.99)

−3.2 (1.96)

−2.0 (1.58)

        

  LS mean change (SE)a

−3.18 (0.16)

−3.28 (0.16)

−3.23 (0.11)

−1.95 (0.16)

−3.06 (0.22)

−3.35 (0.22)

−3.21 (0.16)

−2.04 (0.22)

−3.30 (0.24)

−3.19 (0.24)

−3.25 (0.17)

−1.87 (0.24)

  LS mean differencea

−1.23

−1.32

−1.28

 

−1.03

−1.32

−1.17

 

−1.43

−1.32

−1.37

 

  P value versus placeboa

**

**

**

 

**

**

**

 

**

**

**

 

  95% CIa

(−1.68, −0.78)

(−1.77, −0.87)

(−1.66, −0.89)

 

(−1.65, −0.41)

(−1.93, −0.70)

(−1.71, −0.64)

 

(−2.09, −0.77)

(−1.98, −0.65)

(−1.95, −0.80)

 

  P value versus FF 55 µg

     

0.357

   

0.729

  

  95% CIb

     

(−0.91, 0.33)

   

(−0.55, 0.78)

  

Week 1–4 change from baseline

  Mean change (SD)

−3.9 (1.99)

−4.0 (2.05)

−4.0 (2.02)

−2.6 (1.80)

        

  LS mean change (SE)a

−3.93 (0.17)

−4.03 (0.17)

−3.98 (0.12)

−2.57 (0.17)

−3.90 (0.23)

−4.17 (0.22)

−4.03 (0.16)

−2.71 (0.22)

−3.96 (0.25)

−3.88 (0.25)

−3.92 (0.18)

−2.44 (0.25)

  LS mean differencea

−1.36

−1.46

−1.41

 

−1.19

−1.46

−1.33

 

−1.52

−1.44

−1.48

 

  P value versus placeboa

**

**

**

 

**

**

**

 

**

**

**

 

  95% CIa

(−1.83, −0.90)

(−1.92, −0.99)

(−1.81, −1.01)

 

(−1.82, −0.56)

(−2.09, −0.84)

(−1.87, −0.78)

 

(−2.21, −0.83)

(−2.14, −0.74)

(−2.08, −0.88)

 

  P value versus FF 55 µg

     

0.396

   

0.816

  

  95% CIb

     

(−0.09, 0.36)

   

(−0.62, 0.78)

  
  1. CI confidence interval, FFNS fluticasone furoate nasal spray, ITT intent to treat, LS least squares, LS mean difference LS mean change in active treatment minus LS mean change in placebo, rTNSS reflective total nasal symptom scores, SD standard deviation, SE standard error.
  2. **P < 0.001 compared with placebo.
  3. aThe baseline period for diary card endpoints was defined as 4 days before randomization, including the morning symptom assessment on the randomization (i.e., treatment initiation) date.
  4. bBased on ANCOVA adjusting for baseline daily rTNSS, classification of allergic rhinitis (intermittent or persistent), age (as continuous variable), sex, and treatment.
  5. cPrimary analysis data.
  6. dPost hoc analysis data.
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