Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis

Condition(s) targeted: Perennial Allergic Rhinitis

Intervention: Cetirizine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period.

Official title: A Randomized, Double Blind, Placebo Controlled Study for Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup (CTZ DS) (2.5 mg or 5 mg Twice a Day) in Children (2 Years of Age or Older But Under 15 Years Old) Suffering From Perennial Allergic Rhinitis.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary efficacy endpoint is a change in the total nasal symptom score (TNSS) during the total treatment period from the baseline assessment period.

Secondary outcome:

Efficacy Weekly total nasal symptom score (TNSS). Each nasal symptom.Total daily nasal symptom score/TDNS.Investigator global improvement rating/ patient global improvement rating.Nasal findings. Safety

1) Evaluation of the efficacy: To assess the efficacy of CTZ DS in comparison with placebo in the following items (1) Changes in TNSS on the first and the second weeks of the treatment period from the score of the baseline assessment period.

(2) Mean scores for each nasal symptom and the time-course changes for the scores. (3) Time-course changes in a total of daily mean nasal symptom scores (TDNSS).

(4) Investigator global improvement rating on the first day of Treatment Week 2 (D8) and the final observation day (D15) or at discontinuation.

(5) Patient global improvement rating on the first day of Treatment Week 2 (D8) and the final observation day (D15) or at discontinuation..

6) Changes in each nasal finding (swelling and color of inferior conchal mucosa and aqueous secretion volume observed by rhinoscopy) on the first day of Treatment Week 1 (D1), the first day of Treatment Week 2 (D8) and final observation day (D15)　

2) Evaluation of the safety To assess and compare the safety between the 2 groups thorough the trial. 3) Evaluation of Pharmacokinetics

To determine serum CTZ concentration on the first day of Treatment Week 2 (D8) and the final observation day (D15) or at discontinuation to investigate the pharmacokinetics in the population of children.

Minimum age: 2 Years. Maximum age: 14 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- [Before the start of observation period]

1. Children with a history of hypersensitivity to an ingredient of cetirizine hydrochloride 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., hepatic

disorder, renal disorder, heart disease or others) because of which they are judged as inappropriate for this trial.

- Children who are sensitive to pollen as a duplicate allergen and whose treatment

periods 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 the study drugs.

- Children complicated with asthma that requires the treatment with adrenocortical

hormone (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 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

- Children who have started specific desensitization treatment or nonspecific

modulation treatment but who have not reached the maintenance level of treatment.

- Children who have received surgical treatment for reduction and modulation of

nasal mucosa, redintegration therapy of nasal cavity to improve the degree of nasal 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 the

date of informed consent for this clinical study or children who are participating in another trial as of the date of informed consent for this trial.

- Children judged by the investigator or sub-investigator as inappropriate to

participate in the trial.

[Before the start of treatment period] - Children whose severity score calculated by the

following formula on the basis of nasal symptom score (sneezing, rhinorrhea, nasal pruritus and nasal congestion) in the baseline assessment period (3 days from D5 to D7) is 10 or higher 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 observation

period.

- Children who are applicable to the exclusion criteria as to the status [before the

start 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 cetirizine hydrochloride 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., hepatic disorder, renal disorder, heart disease or others) because of which they are judged as inappropriate for this trial.

5. Children who are sensitive to pollen as a duplicate allergen and whose treatment periods 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, nasal polyp, etc.) with a degree that may influence on the evaluation of the study drugs.

8. Children complicated with asthma that requires the treatment with adrenocortical hormone (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 modulation treatment but who have not reached the maintenance level of treatment.

11. Children who have received surgical treatment for reduction and modulation of nasal mucosa, 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 of informed consent for this clinical study or children who are participating in another trial as of the date of informed consent for this trial.

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

[Before the start of treatment period]

1） Children whose severity score calculated by the following formula on the basis of nasal symptom score (sneezing, rhinorrhea, nasal pruritus and nasal congestion) in the baseline assessment 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 drugs during the observation period.

3) Children who have complicated acute upper airway inflammation during the observation period.

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

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Starting date: July 2007
Ending date: October 2007
Last updated: March 10, 2008