Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial

• Registration Number: NCT00490204
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-21
• Study First Posted: 2007-06-22
• Study Start: 2007-07-27
• Primary Completion: 2007-10-03
• Study Completion: 2007-10-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline	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

Name	Time	Method
Changes in TNSS on the first and the second weeks of the treatment period from the baseline	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.
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)	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.
Time-course changes in a total of daily mean nasal symptom scores (TDNSS)	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.
Mean scores for each nasal symptom and the time-course changes for the scores	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.
Participant global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC	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	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).

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan