Trial Outcomes & Findings for ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life) (NCT NCT00160680)
NCT ID: NCT00160680
Last Updated: 2023-08-31
Results Overview
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
COMPLETED
PHASE4
62 participants
During the treatment period until week 24
2023-08-31
Participant Flow
The study started to enroll patients in March 2005 and concluded in June 2006.
Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Continuous Treatment (CT)
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
| Measure |
Continuous Treatment (CT)
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
Baseline Characteristics
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Baseline characteristics by cohort
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
Total Title
n=62 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
34.74 years
STANDARD_DEVIATION 12.33 • n=5 Participants
|
35.20 years
STANDARD_DEVIATION 10.71 • n=7 Participants
|
34.97 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the treatment period until week 24Population: Only patients with a valid mean weekly T4SS during the treatment period were included in the analysis.
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=29 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=29 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
|
2.89 units on a scale
Standard Error 0.43
|
3.15 units on a scale
Standard Error 0.44
|
SECONDARY outcome
Timeframe: During month 1 of the 6 months treatment periodPopulation: Only patients with a valid T4SS at month 1 were included in the analysis.
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=28 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=29 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
|
4.55 units on a scale
Standard Error 0.61
|
3.83 units on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: During month 2 of the 6 months treatment periodPopulation: Only patients with a valid T4SS at month 2 were included in the analysis.
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=27 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=26 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
|
4.04 units on a scale
Standard Error 0.63
|
3.14 units on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: During month 3 of the 6 months treatment periodPopulation: Only patients with a valid T4SS at month 3 were included in the analysis.
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=25 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=24 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
|
2.98 units on a scale
Standard Error 0.50
|
2.58 units on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: During month 4 of the 6 months treatment periodPopulation: Only patients with a valid T4SS at month 4 were included in the analysis.
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=26 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=20 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
|
2.47 units on a scale
Standard Error 0.47
|
2.67 units on a scale
Standard Error 0.50
|
SECONDARY outcome
Timeframe: During month 5 of the 6 months treatment periodPopulation: Only patients with a valid T4SS at month 5 were included in the analysis.
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=22 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=18 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
|
1.74 units on a scale
Standard Error 0.45
|
3.31 units on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: During month 6 of the 6 months treatment periodPopulation: Only patients with a valid T4SS at month 6 were included in the analysis.
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=19 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=19 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
|
2.19 units on a scale
Standard Error 0.57
|
3.64 units on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: During the treatment period until week 24Population: 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean weekly individual symptoms scores were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Weekly Individual Symptoms Scores During the Treatment Period
Sneezing Score
|
0.82 units on a scale
Standard Error 0.11
|
0.94 units on a scale
Standard Error 0.12
|
|
Mean Weekly Individual Symptoms Scores During the Treatment Period
Rhinorrhea Score
|
0.80 units on a scale
Standard Error 0.12
|
0.80 units on a scale
Standard Error 0.12
|
|
Mean Weekly Individual Symptoms Scores During the Treatment Period
Nasal Pruritus Score
|
0.71 units on a scale
Standard Error 0.12
|
0.74 units on a scale
Standard Error 0.12
|
|
Mean Weekly Individual Symptoms Scores During the Treatment Period
Ocular Pruritus Score
|
0.55 units on a scale
Standard Error 0.10
|
0.68 units on a scale
Standard Error 0.10
|
|
Mean Weekly Individual Symptoms Scores During the Treatment Period
Nasal Congestion Score
|
0.87 units on a scale
Standard Error 0.14
|
1.08 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: During month 1 of the 6 months treatment periodPopulation: 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 1 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Sneezing Score
|
1.31 units on a scale
Standard Error 0.15
|
1.12 units on a scale
Standard Error 0.15
|
|
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Rhinorrhea Score
|
1.33 units on a scale
Standard Error 0.16
|
0.93 units on a scale
Standard Error 0.16
|
|
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Nasal Pruritus Score
|
1.06 units on a scale
Standard Error 0.17
|
0.97 units on a scale
Standard Error 0.16
|
|
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Ocular Pruritus Score
|
0.90 units on a scale
Standard Error 0.17
|
0.86 units on a scale
Standard Error 0.17
|
|
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Nasal Congestion Score
|
1.25 units on a scale
Standard Error 0.19
|
1.25 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: During month 2 of the 6 months treatment periodPopulation: 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 2 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Sneezing Score
|
1.20 units on a scale
Standard Error 0.16
|
0.87 units on a scale
Standard Error 0.16
|
|
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Rhinorrhea Score
|
1.14 units on a scale
Standard Error 0.17
|
0.80 units on a scale
Standard Error 0.17
|
|
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Nasal Pruritus Score
|
0.98 units on a scale
Standard Error 0.16
|
0.75 units on a scale
Standard Error 0.16
|
|
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Ocular Pruritus Score
|
0.77 units on a scale
Standard Error 0.17
|
0.77 units on a scale
Standard Error 0.17
|
|
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Nasal Congestion Score
|
1.03 units on a scale
Standard Error 0.19
|
1.04 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: During month 3 of the 6 months treatment periodPopulation: 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 3 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Sneezing Score
|
0.82 units on a scale
Standard Error 0.14
|
0.81 units on a scale
Standard Error 0.15
|
|
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Rhinorrhea Score
|
0.84 units on a scale
Standard Error 0.14
|
0.66 units on a scale
Standard Error 0.14
|
|
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Nasal Pruritus Score
|
0.74 units on a scale
Standard Error 0.13
|
0.53 units on a scale
Standard Error 0.13
|
|
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Ocular Pruritus Score
|
0.61 units on a scale
Standard Error 0.13
|
0.60 units on a scale
Standard Error 0.14
|
|
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Nasal Congestion Score
|
0.87 units on a scale
Standard Error 0.16
|
0.91 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: During month 4 of the 6 months treatment periodPopulation: 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 4 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Sneezing Score
|
0.78 units on a scale
Standard Error 0.14
|
0.85 units on a scale
Standard Error 0.15
|
|
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Rhinorrhea Score
|
0.69 units on a scale
Standard Error 0.14
|
0.72 units on a scale
Standard Error 0.14
|
|
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Nasal Pruritus Score
|
0.60 units on a scale
Standard Error 0.13
|
0.59 units on a scale
Standard Error 0.14
|
|
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Ocular Pruritus Score
|
0.44 units on a scale
Standard Error 0.11
|
0.53 units on a scale
Standard Error 0.12
|
|
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Nasal Congestion Score
|
0.75 units on a scale
Standard Error 0.15
|
1.07 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: During month 5 of the 6 months treatment periodPopulation: 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 5 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Sneezing Score
|
0.51 units on a scale
Standard Error 0.12
|
1.00 units on a scale
Standard Error 0.13
|
|
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Rhinorrhea Score
|
0.51 units on a scale
Standard Error 0.14
|
0.93 units on a scale
Standard Error 0.15
|
|
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Nasal Pruritus Score
|
0.44 units on a scale
Standard Error 0.12
|
0.77 units on a scale
Standard Error 0.13
|
|
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Ocular Pruritus Score
|
0.27 units on a scale
Standard Error 0.10
|
0.63 units on a scale
Standard Error 0.11
|
|
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Nasal Congestion Score
|
0.63 units on a scale
Standard Error 0.15
|
1.08 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: During month 6 of the 6 months treatment periodPopulation: 31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 6 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion. The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Continuous Treatment (CT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (ODT)
n=31 Participants
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Sneezing Score
|
0.61 units on a scale
Standard Error 0.15
|
1.11 units on a scale
Standard Error 0.16
|
|
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Rhinorrhea Score
|
0.57 units on a scale
Standard Error 0.15
|
1.00 units on a scale
Standard Error 0.16
|
|
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Nasal Pruritus Score
|
0.59 units on a scale
Standard Error 0.15
|
0.84 units on a scale
Standard Error 0.16
|
|
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Ocular Pruritus Score
|
0.36 units on a scale
Standard Error 0.14
|
0.69 units on a scale
Standard Error 0.14
|
|
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Nasal Congestion Score
|
0.82 units on a scale
Standard Error 0.17
|
1.15 units on a scale
Standard Error 0.18
|
Adverse Events
Continuous Treatment (SS)
On Demand Treatment (SS)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Treatment (SS)
n=30 participants at risk
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
|
On Demand Treatment (SS)
n=32 participants at risk
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
|
|---|---|---|
|
Infections and infestations
Pharyngitis
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
6.2%
2/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
9.4%
3/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
6.2%
2/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Ear and labyrinth disorders
Eustachian tube obstruction
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
1/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
0.00%
0/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
General disorders
Pain
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Infections and infestations
Ear infection
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
3.1%
1/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
6.2%
2/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/30 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
6.2%
2/32 • Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60