Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis

Inclusion criteria:

• [Before the start of observation period]

1. Children with a history of hypersensitivity to an ingredient of cetirizinehydrochloride preparation, or hydroxyzine, cyclizine, meclozine, buclizine.

• Children with a history of drug hypersensitivity.

• Pregnant, lactating or possibly pregnant female children.

• Children with complications that may be clinically significant (e.g., hepaticdisorder, renal disorder, heart disease or others) because of which they arejudged as inappropriate for this trial.

• Children who are sensitive to pollen as a duplicate allergen and whose treatmentperiods are thought in the pollen dispersion periods.

• Children with vasomotor rhinitis and eosinophilic rhinitis.

• Children complicated with a nasal disorder (e.g., acute or chronic rhinitis,hypertrophic rhinitis, acute or chronic sinusitis, deviation of nasal septum,nasal polyp, etc.) with a degree that may influence on the evaluation of thestudy drugs.

• Children complicated with asthma that requires the treatment with adrenocorticalhormone (including the preparations compounded with adrenocortical hormone).

• Children administered the following drugs within one week (6days) or 4 weeks (27days) before the start of the observation period [within one week] •Anti-histamine drugs (oral, injection, and nasal drop) • Chemical mediatorrelease inhibitors (mast cell stabilizer) • Th2 cytokine inhibitors (suplatasttosilate) • Leukotriene receptor antagonists • Thromboxane A2 receptorantagonists

• Thromboxane synthetase inhibitors

• Biological preparations and vaccines indicated against allergic rhinitis

• Vasoconstrictor(oral and nasal drop)

• Anticholinergic drugs (inhalant only)

• General cold remedies (including OTC)

• Herb medicines that have antiallergic action (SHOSEIRYUTO, SHOSAIKOTO,SAIBOKUTO, etc.)

• OTC anti-rhinitis drugs (oral, inhalant, nasal drop) [within 4 weeks]

• Adrenocortical hormones (oral [including combination drugs], injection,inhalant, nasal drop, suppository)

• Histamine added γ-globulin preparations

• Children who have started specific desensitization treatment or nonspecificmodulation treatment but who have not reached the maintenance level of treatment.

• Children who have received surgical treatment for reduction and modulation ofnasal mucosa, redintegration therapy of nasal cavity to improve the degree ofnasal airway, or surgical operation to improve rhinorrhea.

• Children who have previously taken the investigational products of this trial.

• Children who have participated in other clinical trial within 6 months of thedate of informed consent for this clinical study or children who areparticipating in another trial as of the date of informed consent for this trial.

• Children judged by the investigator or sub-investigator as inappropriate toparticipate in the trial.

[Before the start of treatment period] - Children whose severity score calculated by thefollowing formula on the basis of nasal symptom score (sneezing, rhinorrhea, nasal pruritusand nasal congestion) in the baseline assessment period (3 days from D5 to D7) is 10 orhigher Severity of TNSS = [TDNSS(D-3)+TDNSS(D-2)+TDNSS(D-1)]/3

• Children who have used prohibited concomitant drugs during the observation period.

• Children who have complicated acute upper airway inflammation during the observationperiod.

• Children who are applicable to the exclusion criteria as to the status [before thestart of observation period] during the observation period." gher

Exclusion criteria:

"[Before the start of observation period]

1. Children with a history of hypersensitivity to an ingredient of cetirizinehydrochloride preparation, or hydroxyzine, cyclizine, meclozine, buclizine.

2. Children with a history of drug hypersensitivity.

3. Pregnant, lactating or possibly pregnant female children.

4. Children with complications that may be clinically significant (e.g., hepaticdisorder, renal disorder, heart disease or others) because of which they are judged asinappropriate for this trial.

5. Children who are sensitive to pollen as a duplicate allergen and whose treatmentperiods are thought in the pollen dispersion periods.

6. Children with vasomotor rhinitis and eosinophilic rhinitis.

7. Children complicated with a nasal disorder (e.g., acute or chronic rhinitis,hypertrophic rhinitis, acute or chronic sinusitis, deviation of nasal septum, nasalpolyp, etc.) with a degree that may influence on the evaluation of the study drugs.

8. Children complicated with asthma that requires the treatment with adrenocorticalhormone (including the preparations compounded with adrenocortical hormone).

9. Children administered the following drugs within one week (6days) or 4 weeks (27days)before the start of the observation period [within one week]

• Anti-histamine drugs (oral, injection, and nasal drop)

• Chemical mediator release inhibitors (mast cell stabilizer)

• Th2 cytokine inhibitors (suplatast tosilate)

• Leukotriene receptor antagonists

• Thromboxane A2 receptor antagonists

• Thromboxane synthetase inhibitors

• Biological preparations and vaccines indicated against allergic rhinitis

• Vasoconstrictor(oral and nasal drop)

• Anticholinergic drugs (inhalant only)

• General cold remedies (including OTC)

• Herb medicines that have antiallergic action (SHOSEIRYUTO, SHOSAIKOTO, SAIBOKUTO,etc.)

• OTC anti-rhinitis drugs (oral, inhalant, nasal drop) [within 4 weeks]

• Adrenocortical hormones (oral [including combination drugs], injection, inhalant,nasal drop, suppository)

• Histamine added γ-globulin preparations

10. Children who have started specific desensitization treatment or nonspecific modulationtreatment but who have not reached the maintenance level of treatment.

11. Children who have received surgical treatment for reduction and modulation of nasalmucosa, redintegration therapy of nasal cavity to improve the degree of nasal airway,or surgical operation to improve rhinorrhea.

12. Children who have previously taken the investigational products of this trial.

13. Children who have participated in other clinical trial within 6 months of the date ofinformed consent for this clinical study or children who are participating in anothertrial as of the date of informed consent for this trial.

14. Children judged by the investigator or sub-investigator as inappropriate toparticipate in the trial.

[Before the start of treatment period]

1） Children whose severity score calculated by the following formula on the basis of nasalsymptom score (sneezing, rhinorrhea, nasal pruritus and nasal congestion) in the baselineassessment period (3 days from D5 to D7) is 10 or higher Severity of TNSS = [TDNSS(D-3)+TDNSS(D-2)+TDNSS(D-1)]/3 2) Children who have used prohibited concomitant drugsduring the observation period.

3. Children who have complicated acute upper airway inflammation during the observationperiod.

4. Children who are applicable to the exclusion criteria as to the status [before the startof observation period] during the observation period."