Back to resultsATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Levocetirizine
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells, ICAM-1, ATAREAL, Xyzal, Levocetirizine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Continuous Treatment
On Demand Treatment
Arm Description
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00160680
First Posted
September 8, 2005
Last Updated
August 29, 2023
Sponsor
UCB S.A. - Pharma Sector
1. Study Identification
Unique Protocol Identification Number
NCT00160680
Brief Title
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Official Title
A Pilot, Open, Monocenter, Randomized Two Parallel Groups, Clinical Efficacy Trial: Comparison Continuous Versus on Demand Regimen of Treatment With Levocetirizine 5 mg Oral Tablets, Once a Day, in Adults Suffering From Persistent Allergic Rhinitis (PER) Over 6 Months
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2005 (Actual)
Primary Completion Date
June 1, 2006 (Actual)
Study Completion Date
June 1, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB S.A. - Pharma Sector
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells, ICAM-1, ATAREAL, Xyzal, Levocetirizine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Treatment
Arm Type
Experimental
Arm Description
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
Arm Title
On Demand Treatment
Arm Type
Experimental
Arm Description
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Other Intervention Name(s)
Xyzal
Intervention Description
Pharmaceutical form: Tablet
Concentration: 5 mg
Route of administration: Oral use
Primary Outcome Measure Information:
Title
Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
Description
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
Secondary Outcome Measure Information:
Title
Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
Description
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
Title
Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
Description
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
Title
Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
Description
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
Title
Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
Description
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
Title
Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
Description
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
Title
Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
Description
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
Title
Mean Weekly Individual Symptoms Scores During the Treatment Period
Description
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
Title
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Description
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
Title
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Description
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
Title
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Description
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
Title
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Description
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
Title
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Description
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
Title
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Genova
Country
Italy
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
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