Rhinitis, Allergic, Perennial
Conditions
Keywords
Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells, ICAM-1, ATAREAL, Xyzal, Levocetirizine
Brief summary
Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.
Interventions
DRUGLevocetirizine
* Pharmaceutical form: Tablet * Concentration: 5 mg * Route of administration: Oral use
Sponsors
UCB S.A. - Pharma Sector
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at least since 2 years. * Positive skin prick test (wheal \> 3 mm larger than the diluent control) or Radio Allergo Sorbent Assay (RAST) (\>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria (less than 1 year). * Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.
Exclusion criteria
* Subjects currently treated by specific parietaria pollen immunotherapy * Subjects suffering from non-allergic asthma * Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids dependent asthma (severe asthma) * Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period | During the treatment period until week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period | During month 2 of the 6 months treatment period | 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. |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period | During month 3 of the 6 months treatment period | 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. |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period | During month 4 of the 6 months treatment period | 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. |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period | During month 5 of the 6 months treatment period | 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. |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period | During month 6 of the 6 months treatment period | 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. |
| Mean Weekly Individual Symptoms Scores During the Treatment Period | During the treatment period until week 24 | 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. |
| Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period | During month 1 of the 6 months treatment period | 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. |
| Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | During month 2 of the 6 months treatment period | 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. |
| Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | During month 3 of the 6 months treatment period | 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. |
| Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | During month 4 of the 6 months treatment period | 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. |
| Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | During month 5 of the 6 months treatment period | 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. |
| Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | During month 6 of the 6 months treatment period | 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. |
| Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | During month 1 of the 6 months treatment period | 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. |
Countries
Italy
Participant flow
Recruitment details
The study started to enroll patients in March 2005 and concluded in June 2006.
Pre-assignment details
Participant Flow refers to the Randomized Set.
Participants by arm
| Arm | Count |
|---|---|
| Continuous Treatment (CT) 5 mg of Levocetirizine (LCTZ) was taken orally once a day. | 31 |
| On Demand Treatment (ODT) 5 mg of Levocetirizine (LCTZ) was taken whenever needed. | 31 |
| Total Title | 62 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Continuous Treatment (CT) | On Demand Treatment (ODT) | Total Title |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 34.74 years STANDARD_DEVIATION 12.33 | 35.20 years STANDARD_DEVIATION 10.71 | 34.97 years STANDARD_DEVIATION 11.46 |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 4 / 30 | 10 / 32 |
| serious Total, serious adverse events | 0 / 30 | 0 / 32 |
Outcome results
Primary
Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
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.
Time frame: During the treatment period until week 24
Population: Only patients with a valid mean weekly T4SS during the treatment period were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Continuous Treatment (CT) | Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period | 2.89 units on a scale | Standard Error 0.43 |
| On Demand Treatment (ODT) | Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period | 3.15 units on a scale | Standard Error 0.44 |
p-value: =0.66795% CI: [-0.96, 1.5]ANCOVA
Secondary
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
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.
Time frame: During month 1 of the 6 months treatment period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Rhinorrhea Score | 1.33 units on a scale | Standard Error 0.16 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Sneezing Score | 1.31 units on a scale | Standard Error 0.15 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Nasal Congestion Score | 1.25 units on a scale | Standard Error 0.18 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Sneezing Score | 1.12 units on a scale | Standard Error 0.15 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Rhinorrhea Score | 0.93 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Nasal Pruritus Score | 0.97 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period | Ocular Pruritus Score | 0.86 units on a scale | Standard Error 0.17 |
Secondary
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
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.
Time frame: During month 2 of the 6 months treatment period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Rhinorrhea Score | 1.14 units on a scale | Standard Error 0.17 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Sneezing Score | 1.20 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Nasal Congestion Score | 1.04 units on a scale | Standard Error 0.18 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Sneezing Score | 0.87 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Rhinorrhea Score | 0.80 units on a scale | Standard Error 0.17 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period | Nasal Pruritus Score | 0.75 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | 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 |
Secondary
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
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.
Time frame: During month 3 of the 6 months treatment period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Rhinorrhea Score | 0.84 units on a scale | Standard Error 0.14 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Sneezing Score | 0.82 units on a scale | Standard Error 0.14 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Nasal Congestion Score | 0.91 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Sneezing Score | 0.81 units on a scale | Standard Error 0.15 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Rhinorrhea Score | 0.66 units on a scale | Standard Error 0.14 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Nasal Pruritus Score | 0.53 units on a scale | Standard Error 0.13 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period | Ocular Pruritus Score | 0.60 units on a scale | Standard Error 0.14 |
Secondary
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
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.
Time frame: During month 4 of the 6 months treatment period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Rhinorrhea Score | 0.69 units on a scale | Standard Error 0.14 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Sneezing Score | 0.78 units on a scale | Standard Error 0.14 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Nasal Congestion Score | 1.07 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Sneezing Score | 0.85 units on a scale | Standard Error 0.15 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Rhinorrhea Score | 0.72 units on a scale | Standard Error 0.14 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Nasal Pruritus Score | 0.59 units on a scale | Standard Error 0.14 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period | Ocular Pruritus Score | 0.53 units on a scale | Standard Error 0.12 |
Secondary
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
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.
Time frame: During month 5 of the 6 months treatment period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Rhinorrhea Score | 0.51 units on a scale | Standard Error 0.14 |
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Ocular Pruritus Score | 0.27 units on a scale | Standard Error 0.1 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Sneezing Score | 0.51 units on a scale | Standard Error 0.12 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Nasal Congestion Score | 1.08 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Sneezing Score | 1.00 units on a scale | Standard Error 0.13 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Rhinorrhea Score | 0.93 units on a scale | Standard Error 0.15 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Nasal Pruritus Score | 0.77 units on a scale | Standard Error 0.13 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period | Ocular Pruritus Score | 0.63 units on a scale | Standard Error 0.11 |
Secondary
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
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.
Time frame: During month 6 of the 6 months treatment period
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Rhinorrhea Score | 0.57 units on a scale | Standard Error 0.15 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | 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 |
| Continuous Treatment (CT) | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Sneezing Score | 0.61 units on a scale | Standard Error 0.15 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Nasal Congestion Score | 1.15 units on a scale | Standard Error 0.18 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Sneezing Score | 1.11 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Rhinorrhea Score | 1.00 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Nasal Pruritus Score | 0.84 units on a scale | Standard Error 0.16 |
| On Demand Treatment (ODT) | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period | Ocular Pruritus Score | 0.69 units on a scale | Standard Error 0.14 |
Secondary
Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
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.
Time frame: During month 1 of the 6 months treatment period
Population: Only patients with a valid T4SS at month 1 were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period | 4.55 units on a scale | Standard Error 0.61 |
| On Demand Treatment (ODT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period | 3.83 units on a scale | Standard Error 0.61 |
Secondary
Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
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.
Time frame: During month 2 of the 6 months treatment period
Population: Only patients with a valid T4SS at month 2 were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period | 4.04 units on a scale | Standard Error 0.63 |
| On Demand Treatment (ODT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period | 3.14 units on a scale | Standard Error 0.63 |
Secondary
Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
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.
Time frame: During month 3 of the 6 months treatment period
Population: Only patients with a valid T4SS at month 3 were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period | 2.98 units on a scale | Standard Error 0.5 |
| On Demand Treatment (ODT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period | 2.58 units on a scale | Standard Error 0.51 |
Secondary
Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
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.
Time frame: During month 4 of the 6 months treatment period
Population: Only patients with a valid T4SS at month 4 were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period | 2.47 units on a scale | Standard Error 0.47 |
| On Demand Treatment (ODT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period | 2.67 units on a scale | Standard Error 0.5 |
Secondary
Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
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.
Time frame: During month 5 of the 6 months treatment period
Population: Only patients with a valid T4SS at month 5 were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period | 1.74 units on a scale | Standard Error 0.45 |
| On Demand Treatment (ODT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period | 3.31 units on a scale | Standard Error 0.48 |
Secondary
Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
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.
Time frame: During month 6 of the 6 months treatment period
Population: Only patients with a valid T4SS at month 6 were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Continuous Treatment (CT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period | 2.19 units on a scale | Standard Error 0.57 |
| On Demand Treatment (ODT) | Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period | 3.64 units on a scale | Standard Error 0.59 |
Secondary
Mean Weekly Individual Symptoms Scores During the Treatment Period
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.
Time frame: During the treatment period until week 24
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Treatment (CT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Rhinorrhea Score | 0.80 units on a scale | Standard Error 0.12 |
| Continuous Treatment (CT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Ocular Pruritus Score | 0.55 units on a scale | Standard Error 0.1 |
| Continuous Treatment (CT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Nasal Pruritus Score | 0.71 units on a scale | Standard Error 0.12 |
| Continuous Treatment (CT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Nasal Congestion Score | 0.87 units on a scale | Standard Error 0.14 |
| Continuous Treatment (CT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Sneezing Score | 0.82 units on a scale | Standard Error 0.11 |
| On Demand Treatment (ODT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Nasal Congestion Score | 1.08 units on a scale | Standard Error 0.14 |
| On Demand Treatment (ODT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Sneezing Score | 0.94 units on a scale | Standard Error 0.12 |
| On Demand Treatment (ODT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Rhinorrhea Score | 0.80 units on a scale | Standard Error 0.12 |
| On Demand Treatment (ODT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Nasal Pruritus Score | 0.74 units on a scale | Standard Error 0.12 |
| On Demand Treatment (ODT) | Mean Weekly Individual Symptoms Scores During the Treatment Period | Ocular Pruritus Score | 0.68 units on a scale | Standard Error 0.1 |