Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist (OPEhRA)

A Randomized Open Labeled Trial to Compare the Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist in Patients With Chronic Urticaria

A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on treatment with H2-receptor antagonist in patients with chronic urticaria

Study Overview

• Status: Completed
• Conditions: Chronic Urticaria

Detailed Description

• For four weeks
• After the researcher confirms the selection / exclusion criteria on the baseline, the UAS, K-UCT, and CU-QoL are created and randomized from the subject.
• Receive UAS, K-UCT, and CU-QoL from the subject during the last visit to assess safety

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon-si, Korea, Republic of
    • Ajou University Medical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic urticaria in Ajou University Hospital

Description

Inclusion Criteria:

• Adolescents and adults over 12 years
• Clinical diagnosis of chronic urticaria due to wheal reaction, itching, angioedema over 6 weeks
• Antihistamine 2 or 2 kinds of treatment for more than 2 weeks even if the symptoms are not controlled
• Those who do not have other chronic skin diseases

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
add H2RA; Add antihistamines to standard drug therapy
change ns-H1RA; Change to ns-H1RA in standard medication
ns-H1RA(3-4 tabs); Standard treatment with ns-H1RA 4X dose
ns-H1RA(3-4kinds); Use of NS 4 kinds for standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of evaluation after 4 weeks treatment by a investigator	0-no effective, 1-ineffective, 2-effective, 3-no symptoms	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral blood eosinophil count	in percentage	4 weeks
Number of evaluation as assessed by questionnaire	Sleepiness, dryness, dysuria	4 weeks
Number of urticaria control by K-UCT	Before and after treatment	4 weeks
Number of urticaria symptom by UAS	Urticaria activity score	4 weeks
Quality of life of chronic urticaria by CU-QoL	Quality of life questionnaire for patients with chronic urticaria	4 weeks
Number of Patient-controlled urticaria by VAS	evaluation of Patient-controlled urticaria	4 weeks
Number of patients using emergency medication	Emergency drug frequency in patients with chronic urticaria	4 weeks
Comparison of Serum total IgE	Comparison each group in treatment activity	4 weeks
Number of physiological parameter	weight gain in kilograms	4 weeks
Number of creatinine, AST/ALT	Creatinine in mg/dl, AST/ALT in UL	4 weeks

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Study Director: Youngmin Ye, Dr, Ajou University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2017
• Primary Completion (ACTUAL): May 24, 2019
• Study Completion (ACTUAL): May 24, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 24, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: cu
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria
• Other Study ID Numbers: AJIRB-MED-OBS-17-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No