ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

Rhinitis, Allergic, Perennial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160680
• Other study ID #: A00392
• Secondary ID: 2004-003858-26
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2005
• Est. completion date: June 1, 2006

Study information

• Verified date: August 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 1, 2006
• Est. primary completion date: June 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß2 agonists; and/or corticosteroids dependent asthma (severe asthma)
• Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Levocetirizine
Pharmaceutical form: Tablet Concentration: 5 mg Route of administration: Oral use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB S.A. - Pharma Sector

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	During the treatment period until week 24
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.	During month 1 of the 6 months treatment period
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.	During month 2 of the 6 months treatment period
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.	During month 3 of the 6 months treatment period
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.	During month 4 of the 6 months treatment period
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.	During month 5 of the 6 months treatment period
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.	During month 6 of the 6 months treatment period
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.	During the treatment period until week 24
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.	During month 1 of the 6 months treatment period
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.	During month 2 of the 6 months treatment period
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.	During month 3 of the 6 months treatment period
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.	During month 4 of the 6 months treatment period
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.	During month 5 of the 6 months treatment period
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.	During month 6 of the 6 months treatment period

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