ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

Study Overview
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Brief Summary
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Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.

Official Title
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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

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Levocetirizine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Treatment<br>5 mg of Levocetirizine (LCTZ) was taken orally once a day. | Drug: Levocetirizine<br>* Pharmaceutical form: Tablet Concentration: 5 mg Route of administration: Oral use<br>* Other names: Xyzal;|
| Experimental: On Demand Treatment<br>5 mg of Levocetirizine (LCTZ) was taken whenever needed. | Drug: Levocetirizine<br>* Pharmaceutical form: Tablet Concentration: 5 mg Route of administration: Oral use<br>* Other names: Xyzal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the treatment period until week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During month 1 of the 6 months treatment period | 
| 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. | During month 2 of the 6 months treatment period | 
| 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. | During month 3 of the 6 months treatment period | 
| 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. | During month 4 of the 6 months treatment period | 
| 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. | During month 5 of the 6 months treatment period | 
| 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. | During month 6 of the 6 months treatment period | 
| 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. | During the treatment period until week 24 | 
| 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. | During month 1 of the 6 months treatment period | 
| 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. | During month 2 of the 6 months treatment period | 
| 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. | During month 3 of the 6 months treatment period | 
| 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. | During month 4 of the 6 months treatment period | 
| 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. | During month 5 of the 6 months treatment period | 
| 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. | During month 6 of the 6 months treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xyzal, Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells, ICAM-1, ATAREAL, Levocetirizine