ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

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

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

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Drug: Levocetirizine

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UCB S.A. - Pharma Sector

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2005
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimated): September 12, 2005

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Xyzal; Levocetirizine; HDM; sneezing; rhinorrhea; ICAM-1; inflammatory cells; Persistent Allergic Rhinitis; Parietaria; ocular pruritus; Rhinasthma; ATAREAL
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Levocetirizine
• Other Study ID Numbers: A00392; 2004-003858-26 (EudraCT Number)