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

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ClinicalTrials.gov Identifier: NCT00653224
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : November 17, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: levocetirizine dihydrochloride
Drug: placebo

  Participant Flow

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
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

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 
Other                2                4 



  Baseline Characteristics

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 
Overall Participants Analyzed 
[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

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) ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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

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

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 ]
  Show Outcome Measure 5

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

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

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 ]
  Show Outcome Measure 8

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

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

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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

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

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 ]
  Show Outcome Measure 17

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

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

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 ]
  Show Outcome Measure 20

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

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

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 ]
  Show Outcome Measure 23

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 64

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 ]
  Show Outcome Measure 65

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 ]
  Show Outcome Measure 66

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 ]
  Show Outcome Measure 67

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 ]
  Show Outcome Measure 68

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 ]
  Show Outcome Measure 69

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 ]
  Show Outcome Measure 70

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 ]
  Show Outcome Measure 71

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 ]
  Show Outcome Measure 72

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 ]
  Show Outcome Measure 73

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 ]
  Show Outcome Measure 74

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 ]
  Show Outcome Measure 75

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 ]
  Show Outcome Measure 76

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 ]
  Show Outcome Measure 77

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 ]
  Show Outcome Measure 78

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 ]
  Show Outcome Measure 79

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 ]
  Show Outcome Measure 80

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 ]
  Show Outcome Measure 81

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 ]
  Show Outcome Measure 82

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 ]
  Show Outcome Measure 83

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 ]
  Show Outcome Measure 84

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 ]
  Show Outcome Measure 85

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 ]
  Show Outcome Measure 86

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 ]
  Show Outcome Measure 87

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

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

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 ]
  Show Outcome Measure 90


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00653224     History of Changes
Other Study ID Numbers: A00431
First Submitted: April 1, 2008
First Posted: April 4, 2008
Results First Submitted: July 28, 2009
Results First Posted: November 17, 2009
Last Update Posted: August 31, 2011