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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Urticaria, Chronic Idiopathic Urticaria

Intervention / Treatment
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* Drug: desloratadine
* Drug: desloratadine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Treatment<br> | Drug: desloratadine<br>* 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.<br>* Other names: SCH 34117;|
| Experimental: PRN regimen<br> | Drug: desloratadine<br>* 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.<br>* Other names: SCH 34117;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of disease free period after 3 months of daily treatment. |  | 2 months | 
| Average usage of rescue medication |  | 2 months | 
| Change from Visit 2 in pruritus symptom score assessed by the patient. |  | 2 months | 
| % of patients free of symptoms 2 months after Visit 4 |  | 2 months | 
| Changes from Visit 2 of overall conditions of CIU |  | 2 months | 
| Discontinuation due to treatment failure |  | 2 months | 
| Investigator's assessment of response to therapy |  | 2 months | 
| Quality of disease control |  | 2 months | 
| Average consumption of treatment between Visit 2 and Visit 5 |  | 4 months |