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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783354
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Urticaria Chronic Idiopathic Urticaria Drug: desloratadine Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : April 1, 2003
Actual Primary Completion Date : February 1, 2004
Actual Study Completion Date : April 1, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

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

Primary Outcome Measures :
  1. Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score. [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Estimation of disease free period after 3 months of daily treatment. [ Time Frame: 2 months ]
  2. Average usage of rescue medication [ Time Frame: 2 months ]
  3. Change from Visit 2 in pruritus symptom score assessed by the patient. [ Time Frame: 2 months ]
  4. % of patients free of symptoms 2 months after Visit 4 [ Time Frame: 2 months ]
  5. Changes from Visit 2 of overall conditions of CIU [ Time Frame: 2 months ]
  6. Discontinuation due to treatment failure [ Time Frame: 2 months ]
  7. Investigator's assessment of response to therapy [ Time Frame: 2 months ]
  8. Quality of disease control [ Time Frame: 2 months ]
  9. Average consumption of treatment between Visit 2 and Visit 5 [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00783354     History of Changes
Other Study ID Numbers: P03147
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Dermatologic Agents
Anti-Allergic Agents