ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

• ClinicalTrials.gov Identifier: NCT00160680
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Results First Posted: January 22, 2019
• Last Update Posted: January 22, 2019
• Sponsor: UCB S.A. - Pharma Sector
• Information provided by (Responsible Party): UCB Pharma ( UCB S.A. - Pharma Sector )

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.

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic, Perennial	Drug: Levocetirizine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 1, 2005
• Actual Primary Completion Date: June 1, 2006
• Actual Study Completion Date: June 1, 2006

Arms and Interventions

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 Name: 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 Name: Xyzal

Outcome Measures

Primary Outcome Measures :

1. Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period [ Time Frame: 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 Outcome Measures :

1. Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period [ Time Frame: 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.
2. Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period [ Time Frame: 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.
3. Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period [ Time Frame: 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.
4. Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period [ Time Frame: 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.
5. Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period [ Time Frame: 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.
6. Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period [ Time Frame: 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.
7. Mean Weekly Individual Symptoms Scores During the Treatment Period [ Time Frame: 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.

8. Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period [ Time Frame: 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.

9. Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period [ Time Frame: 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.

10. Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period [ Time Frame: 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.

11. Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period [ Time Frame: 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.

12. Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period [ Time Frame: 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.

13. Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period [ Time Frame: 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Italy

Genova, Italy

Sponsors and Collaborators

UCB S.A. - Pharma Sector

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB S.A. - Pharma Sector
• ClinicalTrials.gov Identifier: NCT00160680
• Other Study ID Numbers: A00392; 2004-003858-26 ( EudraCT Number )
• First Posted: September 12, 2005
• Results First Posted: January 22, 2019
• Last Update Posted: January 22, 2019
• Last Verified: August 2018

Keywords provided by UCB Pharma ( UCB S.A. - Pharma Sector ):

Persistent Allergic Rhinitis; HDM; Parietaria; sneezing; rhinorrhea; ocular pruritus; Rhinasthma; inflammatory cells; ICAM-1; ATAREAL; Xyzal; Levocetirizine

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Levocetirizine; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs