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Natural History of Chronic Urticaria (NHCU)

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ClinicalTrials.gov Identifier: NCT01284426
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Chronic Urticaria
Enrollment 94

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chronic Urticaria
Hide Arm/Group Description Chronic urticaria, Natural history
Period Title: Overall Study
Started 94
Completed 92
Not Completed 2
Arm/Group Title Chronic Urticaria
Hide Arm/Group Description Chronic urticaria, Natural history
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
Remission period, chronic urticaria
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 92 participants
8.4
(4.0 to 15.5)
[1]
Measure Description: Children 4-15 years of age
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
49
  53.3%
Male
43
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 92 participants
92
1.Primary Outcome
Title Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.
Hide Description

Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria.

Description in details:

Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported.

Time Frame 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Children 4-15 years old with chronic urticaria
Arm/Group Title Chronic Urticaria
Hide Arm/Group Description:
Chronic urticaria, Natural history
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: percentage of participants
Remission rate at 1 year after the onset 18.5
Remission rate at 3 year after the onset 54
Remission rate at 5 year after the onset 67.7
Time Frame 6 years. Actually, this study is the prospective observational study of chronic urticaria for over 6 years regarding only the remission of the disease.
Adverse Event Reporting Description Since we did not add any intervention into the participants, therefore, we did not observe any serious or non-serious adverse events other than the activity or remission of chronic urticaria. However, if we consider as the Total Number of Participants at Risk, the number should be "92 participants" or "100%".
 
Arm/Group Title Chronic Urticaria
Hide Arm/Group Description Chronic urticaria, Natural history
All-Cause Mortality
Chronic Urticaria
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chronic Urticaria
Affected / at Risk (%) # Events
Total   0/92 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chronic Urticaria
Affected / at Risk (%) # Events
Total   62/92 (67.39%)    
Skin and subcutaneous tissue disorders   
Remission of chronic urticaria after 1 year of symptoms * [1]  17/92 (18.48%)  17
Remission of chronic urticaria after 3 years of symptoms * [2]  50/92 (54.35%)  50
Remission of chronic urticaria (CU) after 5 years of symptoms * [3]  62/92 (67.39%)  62
*
Indicates events were collected by non-systematic assessment
[1]
Remission of chronic urticaria (CU) after 1 year of the onset of symptoms was considered if symptoms did not recur for at least 12 months without medication after 1 years of CU symptoms.
[2]
Remission of chronic urticaria (CU) after 3 years of the onset of symptoms was considered if symptoms did not recur for at least 12 months without medication after 3 years of CU symptoms.
[3]
Remission of chronic urticaria (CU) after 5 years of the onset of symptoms was considered if symptoms did not recur for at least 12 months without medication after 5 years of CU symptoms.
This study did not perform basophil histamine releasing assay to identify the existence of functional autoantibodies, since there was no available laboratory to do this test.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Professor Orathai Jirapongsananuruk, Director of Clinical Trials
Organization: Division of Allergy and Immunology, Department of Pediatrics, Siriraj Hospital, Mahidol University
Phone: 024197000
Responsible Party: Orathai Piboonpocanun, Mahidol University
ClinicalTrials.gov Identifier: NCT01284426     History of Changes
Other Study ID Numbers: 374/2551(EC3)
First Submitted: January 20, 2011
First Posted: January 27, 2011
Results First Submitted: August 21, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016