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Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490204
First Posted: June 22, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Rhinitis, Allergic, Perennial Drug: Cetirizine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline [ Time Frame: From Baseline to Day 14 ]
    TNSS is a sum of the nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The Baseline value is defined as the average TNSS over the last 3 consecutive days prior to Day 1. For total treatment period, the average TNSS for each participant was calculated using available diary data from the total treatment period, taking the average of non-missing data during the period. Change from Baseline was calculated as the score at Baseline minus the mean score for the total treatment period.


Secondary Outcome Measures:
  • Changes in TNSS on the first and the second weeks of the treatment period from the baseline [ Time Frame: From Baseline to Day 7 and Day 14 ]
    TNSS is a sum of the nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The Baseline value is defined as the average TNSS over the last 3 consecutive days prior to Day 1. For total treatment period, the average TNSS for each participant was calculated using available diary data from the total treatment period, taking the average of non-missing data during the period. Change from Baseline was calculated as the score at Baseline minus the mean score at Week 1 and Week 2.

  • Mean scores for each nasal symptom and the time-course changes for the scores [ Time Frame: From Baseline to Day 14 ]
    Each nasal symptom score for sneezing, rhinorrhea, nasal congestion and nasal itching is scored on a scale from 0 to 3; the larger score indicates more severe symptoms. The parent/guardian or the participant scored nasal symptoms every day.

  • Time-course changes in a total of daily mean nasal symptom scores (TDNSS) [ Time Frame: From Baseline to Day 14 ]
    TDNSS is a sum of the daily nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is score on a scale from 0 to 3; the range of sums for TDNSS is 0 to 12; a larger score indicates more severe symptoms.

  • Investigator global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15 ) or at discontinuation (DC) [ Time Frame: Day 8 and Day 15 or DC ]
    The investigator evaluated the participant's improvement rating (defined as improvement in the symptoms of rhinitis compared with Baseline), using the following 5 categories: significantly improved, moderately improved, mildly improved, unchanged, and worsened.

  • Participant global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC [ Time Frame: Day 8 and Day 15 or DC ]
    The participant's parent/guardian or the participant evaluated the participant's improvement rating (defined as improvement in the symptoms of rhinitis compared with Baseline), using the following 7 categories: significantly improved, improved, slightly improved, unchanged, slightly worsened, worsened, and significantly worsened.

  • Changes in each rhinoscopy finding (swelling and color of inferior conchal mucosa and aqueous secretion volume (ASV)) on first day of Treatment Week 1 (Day 1), the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC [ Time Frame: Day 1, Day 8 and Day 15 or DC ]
    Rhinoscopy was assessed by the investigator by scoring swelling of inferior conchal mucosa scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 1 and 3), or 3 (impossible to see middle turbinate); color of inferior conchal mucosa scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); aqueous secretion volume (vol) scored as 0 (none), 1 (small amount adhered), 2 (between 1 and 3), or 3 (filled).


Enrollment: 239
Actual Study Start Date: July 27, 2007
Study Completion Date: October 3, 2007
Primary Completion Date: October 3, 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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."

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490204


Locations
Japan
GSK Investigational Site
Chiba, Japan, 277-0882
GSK Investigational Site
Fukuoka, Japan, 807-0856
GSK Investigational Site
Fukuoka, Japan, 811-1201
GSK Investigational Site
Fukuoka, Japan, 819-0002
GSK Investigational Site
Hokkaido, Japan, 001-0923
GSK Investigational Site
Hokkaido, Japan, 007-0840
GSK Investigational Site
Hokkaido, Japan, 053-0833
GSK Investigational Site
Hokkaido, Japan, 061-1133
GSK Investigational Site
Hokkaido, Japan, 061-1448
GSK Investigational Site
Hokkaido, Japan, 062-0034
GSK Investigational Site
Kanagawa, Japan, 212-0027
GSK Investigational Site
Kanagawa, Japan, 213-0011
GSK Investigational Site
Kanagawa, Japan, 216-0002
GSK Investigational Site
Kanagawa, Japan, 222-0011
GSK Investigational Site
Kanagawa, Japan, 224-0003
GSK Investigational Site
Kanagawa, Japan, 232-0056
GSK Investigational Site
Kumamoto, Japan, 862-0952
GSK Investigational Site
Kumamoto, Japan, 862-0962
GSK Investigational Site
Oita, Japan, 870-0021
GSK Investigational Site
Saitama, Japan, 333-0861
GSK Investigational Site
Saitama, Japan, 336-0022
GSK Investigational Site
Saitama, Japan, 350-1205
GSK Investigational Site
Saitama, Japan, 355-0062
GSK Investigational Site
Shizuoka, Japan, 420-0803
GSK Investigational Site
Shizuoka, Japan, 422-8066
GSK Investigational Site
Shizuoka, Japan, 436-0058
GSK Investigational Site
Tokyo, Japan, 157-0067
GSK Investigational Site
Tokyo, Japan, 170-0005
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00490204     History of Changes
Other Study ID Numbers: 110458
First Submitted: June 19, 2007
First Posted: June 22, 2007
Last Update Posted: October 12, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Perennial Allergic Rhinitis
Placebo control
anti-histamine
Cetirizine

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs