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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 )

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE October 10, 2017
Results First Posted Date  ICMJE January 22, 2019
Last Update Posted Date January 22, 2019
Actual Study Start Date  ICMJE March 1, 2005
Actual Primary Completion Date June 1, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Evolution of the mean weekly T4SS (sum of the individual symptoms scores) during 6 months of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Evolution of inflammatory cells concentrations and expression of ICAM-1 in nasal scrapings at baseline/after 1, 3 and 6 months of treatment Evolution of Rhinasthma scores, weekly/monthly number of days with (acute) rhinitis symptoms
  • Intake of concomitant/rescue medication
  • Safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Allergic, Perennial
Intervention  ICMJE Drug: Levocetirizine
  • Pharmaceutical form: Tablet
  • Concentration: 5 mg
  • Route of administration: Oral use
Other Name: Xyzal
Study Arms  ICMJE
  • Experimental: Continuous Treatment
    5 mg of Levocetirizine (LCTZ) was taken orally once a day.
    Intervention: Drug: Levocetirizine
  • Experimental: On Demand Treatment
    5 mg of Levocetirizine (LCTZ) was taken whenever needed.
    Intervention: Drug: Levocetirizine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2018)
62
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
100
Actual Study Completion Date  ICMJE June 1, 2006
Actual Primary Completion Date June 1, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00160680
Other Study ID Numbers  ICMJE A00392
2004-003858-26 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB S.A. - Pharma Sector )
Study Sponsor  ICMJE UCB S.A. - Pharma Sector
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account UCB Pharma
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP