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ATTITUD: A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00783354
Collaborator
(none)
129
Enrollment
2
Arms
12
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN; in the case of symptoms).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Pilot, Multicenter, Double-blind Randomized Study for Comparison of Aerius® "Continuous Treatment" Versus Aerius® "PRN Regimen" on Chronic Idiopathic Urticaria Patient Quality of Life
Actual Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Feb 1, 2004
Actual Study Completion Date :
Apr 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Continuous Treatment

Drug: desloratadine
Patients received desloratadine 5 mg daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (Placebo) in case of symptoms for 2 months.
Other Names:
  • Aerius
  • SCH 34117

    		•
    Experimental: PRN regimen

    Drug: desloratadine
    Patients received Placebo daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (desloratadine 5 mg) in case of symptoms for 2 months.
    Other Names:
  • Aerius
  • SCH 34117

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score. [2 months]

    Secondary Outcome Measures

    1. Estimation of disease free period after 3 months of daily treatment. [2 months]

    2. Average usage of rescue medication [2 months]

    3. Change from Visit 2 in pruritus symptom score assessed by the patient. [2 months]

    4. % of patients free of symptoms 2 months after Visit 4 [2 months]

    5. Changes from Visit 2 of overall conditions of CIU [2 months]

    6. Discontinuation due to treatment failure [2 months]

    7. Investigator's assessment of response to therapy [2 months]

    8. Quality of disease control [2 months]

    9. Average consumption of treatment between Visit 2 and Visit 5 [4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.

    • Subjects must be >= 18 years of age

    • Women of childbearing potential must have a negative urine pregnancy test at Visit 1 (Day 1) and must be using an acceptable method of birth control during the study.

    • Subjects must be in general good health; ie, they must be free of any clinically significant disease (other than CIU) that would interfere with study evaluations.

    • Subjects must understand and be able to adhere to visit schedules, and agree to complete the questionnaires and a diary.

    • Subjects must have at least a 6-week history of CIU (pruritus and hives) prior to Visit 1.

    Exclusion Criteria:

    • Women who are pregnant or nursing.

    • Subjects who used any investigational drug in the last 30 days prior to Visit 1

    • Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.

    • Subjects who have been treated with any investigational antibodies for asthma or allergic rhinitis in the 90 days prior to Baseline.

    • Subjects who have been treated with intra-muscular or intra-articular corticosteroids in the 90 days prior to Baseline.

    • Subjects with urticaria that is primarily due to physical urticaria or other known etiology, except dermographism.

    • Subjects treated by immunosuppressive drugs.

    • Subjects who have been hospitalized (including an emergency department visit) because of deterioration in their CIU within 3 months prior to Visit 1.

    • Subjects with a history of hypersensitivity to desloratadine or any of its excipients.

    • Subjects previously randomized into this study.

    • Subjects who have any clinically significant metabolic, cardiovascular, immunological, neurological, hematological, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.

    • Subjects with a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.

    • Subjects with a history of noncompliance with medications or treatment protocols.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00783354
    Other Study ID Numbers:
    • P03147
    First Posted:
    Oct 31, 2008
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Urticaria
    Chronic Urticaria
    Loratadine
    Desloratadine

    Study Results

    No Results Posted as of Feb 17, 2022