Trial Outcomes & Findings for Natural History of Chronic Urticaria (NCT NCT01284426)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

94 participants

Primary outcome timeframe

6 years

Results posted on

2016-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Chronic Urticaria Chronic urticaria, Natural history
Overall Study STARTED	94
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Natural History of Chronic Urticaria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Urticaria n=92 Participants Chronic urticaria, Natural history
Age, Continuous	8.4 Years n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Region of Enrollment Thailand	92 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years

Population: Children 4-15 years old with chronic urticaria

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.

Outcome measures

Outcome measures
Measure	Chronic Urticaria n=92 Participants Chronic urticaria, Natural history
Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed. Remission rate at 1 year after the onset	18.5 percentage of participants
Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed. Remission rate at 3 year after the onset	54 percentage of participants
Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed. Remission rate at 5 year after the onset	67.7 percentage of participants

Adverse Events

Chronic Urticaria

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chronic Urticaria n=92 participants at risk Chronic urticaria, Natural history
Skin and subcutaneous tissue disorders Remission of chronic urticaria after 1 year of symptoms	18.5% 17/92 • Number of events 17 • 6 years. Actually, this study is the prospective observational study of chronic urticaria for over 6 years regarding only the remission of the disease. 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%".
Skin and subcutaneous tissue disorders Remission of chronic urticaria after 3 years of symptoms	54.3% 50/92 • Number of events 50 • 6 years. Actually, this study is the prospective observational study of chronic urticaria for over 6 years regarding only the remission of the disease. 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%".
Skin and subcutaneous tissue disorders Remission of chronic urticaria (CU) after 5 years of symptoms	67.4% 62/92 • Number of events 62 • 6 years. Actually, this study is the prospective observational study of chronic urticaria for over 6 years regarding only the remission of the disease. 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%".

Additional Information

Professor Orathai Jirapongsananuruk, Director of Clinical Trials

Division of Allergy and Immunology, Department of Pediatrics, Siriraj Hospital, Mahidol University

Phone: 024197000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place