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

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

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.
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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
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

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 ]

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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