A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00653224
First received: April 1, 2008
Last updated: August 29, 2011
Last verified: December 2009
Results First Received: July 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: levocetirizine dihydrochloride
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 580 patients has been recruited and randomized. Baseline Characteristics describe all randomized subjects. Out of the 580 randomized subjects (ITT population), 578 subjects have been treated at least once (Safety population).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Matching oral placebo tablet daily for 14 days
Levocetirizine Levocetirizine (LCTZ) 5 mg tablet daily for 14 days

Participant Flow:   Overall Study
    Placebo     Levocetirizine  
STARTED     293     287  
COMPLETED     286     280  
NOT COMPLETED     7     7  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 2  
Loss of efficacy                 1                 0  
Lost to Follow-up                 1                 0  
Unknown                 2                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matching oral placebo tablet daily for 14 days
Levocetirizine Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total Total of all reporting groups

Baseline Measures
    Placebo     Levocetirizine     Total  
Number of Participants  
[units: participants]
  293     287     580  
Age  
[units: years]
Mean ± Standard Deviation
  37.53  ± 11.68     38.73  ± 11.50     38.13  ± 11.60  
Gender  
[units: participants]
     
Female     182     169     351  
Male     111     118     229  
Region of Enrollment  
[units: participants]
     
United States     293     287     580  



  Outcome Measures
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1.  Primary:   Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)   [ Time Frame: Over the total treatment period (14 days) ]

2.  Secondary:   Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

3.  Secondary:   Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1   [ Time Frame: Baseline and week 1 ]

4.  Secondary:   Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2   [ Time Frame: Baseline and week 2 ]

5.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

6.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1   [ Time Frame: Baseline and week 1 ]

7.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2   [ Time Frame: Baseline and week 2 ]

8.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

9.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1   [ Time Frame: Baseline and week 1 ]

10.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2   [ Time Frame: Baseline and week 2 ]

11.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

12.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1   [ Time Frame: Baseline and week 1 ]

13.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2   [ Time Frame: Baseline and week 2 ]

14.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

15.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1   [ Time Frame: Baseline and week 1 ]

16.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2   [ Time Frame: Baseline and week 2 ]

17.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

18.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1   [ Time Frame: Baseline and week 1 ]

19.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2   [ Time Frame: Baseline and week 2 ]

20.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

21.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1   [ Time Frame: Baseline and week 1 ]

22.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2   [ Time Frame: Baseline and week 2 ]

23.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

24.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1   [ Time Frame: Baseline and week 1 ]

25.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2   [ Time Frame: Baseline and week 2 ]

26.  Secondary:   Total 5 Symptoms Score (T5SS) Over the First Week   [ Time Frame: Over week 1 ]

27.  Secondary:   Total 5 Symptoms Score (T5SS) Over the Second Week   [ Time Frame: Over week 2 ]

28.  Secondary:   Total 4 Symptoms Score (T4SS) Over the First Week   [ Time Frame: Over week 1 ]

29.  Secondary:   Total 4 Symptoms Score (T4SS) Over the Second Week   [ Time Frame: Over week 2 ]

30.  Secondary:   Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

31.  Secondary:   Total Nasal Symptom Score (TNSS) Over the First Week   [ Time Frame: Over week 1 ]

32.  Secondary:   Total Nasal Symptom Score (TNSS) Over the Second Week   [ Time Frame: Over week 2 ]

33.  Secondary:   Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

34.  Secondary:   Total Ocular Symptom Score (TOSS) Over the First Week   [ Time Frame: Over week 1 ]

35.  Secondary:   Total Ocular Symptom Score (TOSS) Over the Second Week   [ Time Frame: Over week 2 ]

36.  Secondary:   Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

37.  Secondary:   Sneezing Score Over the First Week   [ Time Frame: Over week 1 ]

38.  Secondary:   Sneezing Score Over the Second Week   [ Time Frame: Over week 2 ]

39.  Secondary:   Sneezing Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

40.  Secondary:   Rhinorrhea Score Over the First Week   [ Time Frame: Over week 1 ]

41.  Secondary:   Rhinorrhea Score Over the Second Week   [ Time Frame: Over week 2 ]

42.  Secondary:   Rhinorrhea Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

43.  Secondary:   Nasal Congestion Score Over the First Week   [ Time Frame: Over week 1 ]

44.  Secondary:   Nasal Congestion Score Over the Second Week   [ Time Frame: Over week 2 ]

45.  Secondary:   Nasal Congestion Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

46.  Secondary:   Nasal Pruritus Score Over the First Week   [ Time Frame: Over week 1 ]

47.  Secondary:   Nasal Pruritus Score Over the Second Week   [ Time Frame: Over week 2 ]

48.  Secondary:   Nasal Pruritus Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

49.  Secondary:   Post-nasal Drip Score Over the First Week   [ Time Frame: Over week 1 ]

50.  Secondary:   Post-nasal Drip Score Over the Second Week   [ Time Frame: Over week 2 ]

51.  Secondary:   Post-nasal Drip Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

52.  Secondary:   Ocular Pruritus Score Over the First Week   [ Time Frame: Over week 1 ]

53.  Secondary:   Ocular Pruritus Score Over the Second Week   [ Time Frame: Over week 2 ]

54.  Secondary:   Ocular Pruritus Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

55.  Secondary:   Ocular Itching/Burning Score Over the First Week   [ Time Frame: Over week 1 ]

56.  Secondary:   Ocular Itching/Burning Score Over the Second Week   [ Time Frame: Over week 2 ]

57.  Secondary:   Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

58.  Secondary:   Ocular Tearing/Watering Score Over the First Week   [ Time Frame: Over week 1 ]

59.  Secondary:   Ocular Tearing/Watering Score Over the Second Week   [ Time Frame: Over week 2 ]

60.  Secondary:   Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

61.  Secondary:   Ocular Redness Score Over the First Week   [ Time Frame: Over week 1 ]

62.  Secondary:   Ocular Redness Score Over the Second Week   [ Time Frame: Over week 2 ]

63.  Secondary:   Ocular Redness Score Over the Total Treatment Period (14 Days)   [ Time Frame: Over total treatment period (14 days) ]

64.  Secondary:   Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

65.  Secondary:   Global Physician’s Rating of Efficacy at Endpoint During the Two Week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

66.  Secondary:   Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

67.  Secondary:   Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1   [ Time Frame: Baseline and week 1 ]

68.  Secondary:   Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2   [ Time Frame: Baseline and week 2 ]

69.  Secondary:   Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

70.  Secondary:   Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1   [ Time Frame: Baseline and week 1 ]

71.  Secondary:   Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2   [ Time Frame: Baseline and week 2 ]

72.  Secondary:   Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

73.  Secondary:   Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1   [ Time Frame: Baseline and week 1 ]

74.  Secondary:   Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2   [ Time Frame: Baseline and week 2 ]

75.  Secondary:   Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

76.  Secondary:   Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1   [ Time Frame: Baseline and week 1 ]

77.  Secondary:   Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2   [ Time Frame: Baseline and week 2 ]

78.  Secondary:   Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

79.  Secondary:   Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1   [ Time Frame: Baseline and week 1 ]

80.  Secondary:   Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2   [ Time Frame: Baseline and week 2 ]

81.  Secondary:   Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

82.  Secondary:   Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1   [ Time Frame: Baseline and week 1 ]

83.  Secondary:   Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2   [ Time Frame: Baseline and week 2 ]

84.  Secondary:   Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

85.  Secondary:   Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1   [ Time Frame: Baseline and week 1 ]

86.  Secondary:   Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2   [ Time Frame: Baseline and week 2 ]

87.  Secondary:   Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]

88.  Secondary:   Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1   [ Time Frame: Baseline and week 1 ]

89.  Secondary:   Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2   [ Time Frame: Baseline and week 2 ]

90.  Secondary:   Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period   [ Time Frame: Baseline and at endpoint of the 2 week treatment period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00653224     History of Changes
Other Study ID Numbers: A00431
Study First Received: April 1, 2008
Results First Received: July 28, 2009
Last Updated: August 29, 2011
Health Authority: United States: Food and Drug Administration