Rupatadine oral solution for 2–5-year-old children with allergic rhinitis: a safety, open-label, prospective study

Figures & data

Table 1 Demographic and other baseline characteristics

Variable	Mean (SD), N=44
Sex (male)a	24 (54.6%)
Age (years)	3.93 (1.00)
Racea
Caucasian	8 (18.2%)
Black	3 (6.8%)
Multiracial	33 (75.0%)
Height (m)	1.00 (0.09)
Weight (kg)	15.3 (3.07)
BMI (kg/m^2)	15.3 (1.85)
Allergen distributiona,b
House dust mite	32 (78.8%)
Grass	24 (58.5%)
Pets	4 (9.8%)
Fungal spores	12 (29.3%)
T5SS	8.65 (1.84)

Note:

a n (%);

b 1 patient may be positive for 1 or more allergen.

Abbreviations: BMI, body mass index; T5SS, Total Five Symptoms Score.

Table 2 Adverse events

Adverse drug event	N=44
	e (%)a/n (%)b
Ear pain	1 (6.7)/1 (2.3)
Conjunctivitis	2 (13.3)/2 (4.5)
Diarrhea	1 (6.7)/1 (2.3)
Mouth ulceration	1 (6.7)/1 (2.3)
Pyrexia	1 (6.7)/1 (2.3)
Oral herpes	1 (6.7)/1 (2.3)
Upper respiratory tract infection	1 (6.7)/1 (2.3)
Viral infection	3 (20.0)/2 (4.5)
Sunburn	1 (6.7)/1 (2.3)
Blood creatinine phosphokinase increased	1 (6.7)/1 (2.3)
Bronchospasm	1 (6.7)/1 (2.3)
Eczema	1 (6.7)/1 (2.3)

Note:

a Number of episodes;

b number of patients.

Figure 1 Mean (SD) absolute T5SS values at baseline and Days 14 and 28.

Note: *p<0.001 compared to baseline.
Abbreviation: T5SS, Total Five Symptoms Score.

Figure 2 Mean (SD) absolute individual values in each symptom score at baseline and Days 14 and 28.

Figure 3 Mean (SD) daily T5SS absolute values during 28 days.

Abbreviation: T5SS, Total Five Symptoms Score.