- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783354
A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147) (ATTITUD)
February 7, 2022 updated by: Organon and Co
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
129
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Continuous Treatment
|
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:
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:
|
Experimental: PRN regimen
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score.
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Estimation of disease free period after 3 months of daily treatment.
Time Frame: 2 months
|
2 months
|
Average usage of rescue medication
Time Frame: 2 months
|
2 months
|
Change from Visit 2 in pruritus symptom score assessed by the patient.
Time Frame: 2 months
|
2 months
|
% of patients free of symptoms 2 months after Visit 4
Time Frame: 2 months
|
2 months
|
Changes from Visit 2 of overall conditions of CIU
Time Frame: 2 months
|
2 months
|
Discontinuation due to treatment failure
Time Frame: 2 months
|
2 months
|
Investigator's assessment of response to therapy
Time Frame: 2 months
|
2 months
|
Quality of disease control
Time Frame: 2 months
|
2 months
|
Average consumption of treatment between Visit 2 and Visit 5
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2003
Primary Completion (Actual)
February 1, 2004
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
October 30, 2008
First Submitted That Met QC Criteria
October 30, 2008
First Posted (Estimate)
October 31, 2008
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Chronic Urticaria
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Dermatologic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Histamine H1 Antagonists, Non-Sedating
- Desloratadine
- Loratadine
Other Study ID Numbers
- P03147
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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