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Trial record 1 of 1 for:    NCT00160680
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ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

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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:
Information provided by (Responsible Party):
UCB Pharma ( UCB S.A. - Pharma Sector )

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

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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

Resource links provided by the National Library of Medicine


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




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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160680


Locations
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Italy
Genova, Italy
Sponsors and Collaborators
UCB S.A. - Pharma Sector
Additional Information:
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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    Key Record Dates
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:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
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