<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296358</url>
  </required_header>
  <id_info>
    <org_study_id>668/2017</org_study_id>
    <nct_id>NCT03296358</nct_id>
  </id_info>
  <brief_title>Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines in Emergency Department.</brief_title>
  <official_title>A Randomized, Double-blinded, Controlled Trial of Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double-blinded, controlled trial of adding a short burst of corticosteroid to&#xD;
      the conventional treatment of H1 antihistamines&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Methodology&#xD;
&#xD;
      Target Population Patients visit emergency room at King chulalongkorn memorial hospital&#xD;
      (KCMH) age between 18-50 years who meet the following criteria of acute urticarial such as&#xD;
&#xD;
        1. eruption of wheals, central swelling of various sizes, with or without surrounding&#xD;
           erythema; with or without angioedema&#xD;
&#xD;
        2. pruritus or occasional burning sensation&#xD;
&#xD;
        3. skin returning to normal appearance, usually within 1-24 hours&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
        1. patients who have urticarial for more than 48 hours&#xD;
&#xD;
        2. have severe underlying disease such as heart disease, kidney disease, liver disease&#xD;
&#xD;
        3. pregnancy&#xD;
&#xD;
        4. history of Chlorpheniramine, steroid, antihistamines allergy&#xD;
&#xD;
        5. history of antihistamine or steroid uses within 48 hours before emergency department&#xD;
           visit&#xD;
&#xD;
        6. diabetes mellitus&#xD;
&#xD;
        7. suspected of more severe disease or severe allergic reaction&#xD;
&#xD;
        8. patients who don't have pruritus&#xD;
&#xD;
        9. patients who have history of chronic urticaria&#xD;
&#xD;
      Informed consent process The doctor who is the principal investigator or his assigned&#xD;
      colleagues describe the research's details and methods to an enrolled patients. The documents&#xD;
      which contain the details of the research project are also given. Inform consents then were&#xD;
      signed before the beginning of the experiment.&#xD;
&#xD;
      The volunteer would be in a research process during their first 1-2 hours in emergency&#xD;
      department, with the follow up time at 1 week and 1 month&#xD;
&#xD;
      After the investigator complete the inclusion and exclusion criteria, the participants would&#xD;
      be random into 3 groups. The randomization process would already be prepared into 3 groups&#xD;
      with a number coding by the statistician who doesn't get involve in the rest of experiment.&#xD;
      The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination&#xD;
      :&#xD;
&#xD;
        1. Control group : Chlorpheniramine 10 mg/amp ; 1 ampule and cetirizine 10 mg 7 tabs&#xD;
&#xD;
        2. Experiment group : Chlorpheniramine 10 mg/amp ; 1 ampule, Dexamethasone 5 mg/amp; 1&#xD;
           ampule and cetirizine 10 mg 7 tabs&#xD;
&#xD;
        3. Experiment group : Chlorpheniramine 10 mg/amp ; 1 ampule, Dexamethasone 5 mg/amp; 1&#xD;
           ampule, cetirizine 10 mg 7 tabs, and prednisolone 5 mg 20 tabs After the envelopes are&#xD;
           sealed, it will be code in an order of number. All of the enrolled patients will get&#xD;
           Chlorpheniramine 10 mg intravenous. The patients who are assigned in experiment group&#xD;
           will get an additional Dexamethasone 5 mg intravenous. The preparation of both drugs&#xD;
           will be result to be a 10 ml of clear fluid. The control group will get a 10 ml of&#xD;
           sterile fluid in 10 ml syringe as a placebo. The drugs will be prepared and delivered be&#xD;
           the nurse who knows about the research process but does not get involved in other&#xD;
           process of the research.&#xD;
&#xD;
      After the experiment period in emergency department, all of the enrolled patients will get&#xD;
      cetirizine 10 mg 7 tabs as a home medication. One experiment group will get prednisolone 5 mg&#xD;
      20 tabs. They will be appointed to an outpatient department in 1 week and 1 month for the&#xD;
      follow up of an acute urticarial rash.&#xD;
&#xD;
      Sample size calculation Investigators do the hypothesis that the experiment groups who get&#xD;
      both Chlorpheniramine 10 mg and Dexamethasone 5 mg intravenous would have the itch score&#xD;
      decrease at least 2 points so this experiment wants minimal clinical difference at &quot;2&quot;. This&#xD;
      number got from our expert in immunology and skin disease. The standard deviation for this&#xD;
      experiment is 2.1 from the previous research. Calculated by G*Power version 3.1 (Dusseldorf,&#xD;
      Germany) for an independent t-test , two-tailed analysis, alpha error probability = 0.05 and&#xD;
      power of analysis (1-beta error probability) = 0.90 The sample size for each group is 23&#xD;
      persons so the patients enroll in this research would be 69 persons.&#xD;
&#xD;
      Data Collection&#xD;
&#xD;
        1. Sex and age&#xD;
&#xD;
        2. Time since the first rash erupt before coming to emergency department (hrs)&#xD;
&#xD;
        3. %body surface area of rash involved&#xD;
&#xD;
        4. Urticarial activity score (UAS) before and after treatment&#xD;
&#xD;
        5. Itch score (Visual analog scale (VAS) score) by letting the patients mark a cross on a&#xD;
           straight line. The end of the left side of a line represents &quot;0 = no pain at all&quot;, and&#xD;
           the end of the right side of a line represents &quot;10 = the worst pain ever possible&quot;. The&#xD;
           patients aren't allowed to compare the previous VAS score before doing the cross.&#xD;
&#xD;
        6. Side effect of drugs&#xD;
&#xD;
        7. Other medicine used as indicated&#xD;
&#xD;
        8. Patients' satisfaction score&#xD;
&#xD;
        9. The recurrence of rash 1 week after the rash onset&#xD;
&#xD;
       10. The recurrence of rash 1 month after the rash onset which will be evaluate by an expert&#xD;
           in immunology and skin disease.&#xD;
&#xD;
      Data Analysis and Statistics&#xD;
&#xD;
      Descriptive statistics : Chi-square Student t-test and paired t-test for data analysis of&#xD;
      continuous variables (such as itch score (VAS) and pair wise comparison for cumulative&#xD;
      increase in the proportion of the &quot;responder&quot; over the time&#xD;
&#xD;
      Statistical significant when p-value &lt; 0.05&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Itch score</measure>
    <time_frame>60 mins</time_frame>
    <description>letting the patients mark a cross on a straight line. The end of the left side of a line represents &quot;0 = no itch at all&quot;, and the end of the right side of a line represents &quot;10 = the worst itch ever possible&quot;. The patients aren't allowed to compare the previous VAS score before doing the cross.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic urticaria incidence</measure>
    <time_frame>1 week, 1 month</time_frame>
    <description>Chronic urticaria incidence after the use of steroid compare with no steroid use in treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch score</measure>
    <time_frame>0, 15, 30 mins</time_frame>
    <description>letting the patients mark a cross on a straight line. The end of the left side of a line represents &quot;0 = no itch at all&quot;, and the end of the right side of a line represents &quot;10 = the worst itch ever possible&quot;. The patients aren't allowed to compare the previous VAS score before doing the cross.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Urticaria</condition>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Chlorpheniramine 10 mg/amp ; 1 ampule Cetirizine 10 mg 7 tabs once daily (OD) as home medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experiment 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experiment 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication Oral prednisolone 5 mg 20 tabs ; 2*2 po pc as home medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV Dexamethasone</intervention_name>
    <description>The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 1 and Experiment 2 groups would receive IV Dexamethasone in emergency department (ED).</description>
    <arm_group_label>Experiment 1</arm_group_label>
    <arm_group_label>Experiment 2</arm_group_label>
    <other_name>Decadron</other_name>
    <other_name>Dexasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral prednisolone</intervention_name>
    <description>The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 2 groups would receive IV Dexamethasone in ED and Oral prednisolone as home medication.</description>
    <arm_group_label>Experiment 2</arm_group_label>
    <other_name>Orapred</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients visit emergency room at King chulalongkorn memorial hospital (KCMH) age&#xD;
             between 18-50 years who meet the following criteria of acute urticarial such as&#xD;
&#xD;
               1. eruption of wheals, central swelling of various sizes, with or without&#xD;
                  surrounding erythema; with or without angioedema&#xD;
&#xD;
               2. pruritus or occasional burning sensation&#xD;
&#xD;
               3. skin returning to normal appearance, usually within 1-24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who have urticarial for more than 48 hours&#xD;
&#xD;
          2. have severe underlying disease such as heart disease, kidney disease, liver disease&#xD;
&#xD;
          3. pregnancy&#xD;
&#xD;
          4. history of chlorpheniramine maleate, steroid, antihistamines allergy&#xD;
&#xD;
          5. history of antihistamine or steroid uses within 48 hours before ED visit&#xD;
&#xD;
          6. diabetes mellitus&#xD;
&#xD;
          7. suspected of more severe disease or severe allergic reaction&#xD;
&#xD;
          8. patients who don't have pruritus&#xD;
&#xD;
          9. patients who have history of chronic urticaria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pakhawadee Palungwachira, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chulalongkorn Hospital</name>
      <address>
        <city>Pathum Wan</city>
        <state>Bangkok</state>
        <zip>10600</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 8, 2020</last_update_submitted>
  <last_update_submitted_qc>February 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute urticaria</keyword>
  <keyword>Emergency department</keyword>
  <keyword>Acute allergic syndrome</keyword>
  <keyword>Corticosteroid</keyword>
  <keyword>H1-Antihistamines</keyword>
  <keyword>Chronic urticaria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urticaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296358
org study id: 668/2017
nct id: NCT03296358
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized, double-blinded, controlled trial of adding a short burst of corticosteroid to
      the conventional treatment of H1 antihistamines
Research Methodology

      Target Population Patients visit emergency room at King chulalongkorn memorial hospital
      (KCMH) age between 18-50 years who meet the following criteria of acute urticarial such as

        1. eruption of wheals, central swelling of various sizes, with or without surrounding
           erythema; with or without angioedema

        2. pruritus or occasional burning sensation

        3. skin returning to normal appearance, usually within 1-24 hours

      Exclusion criteria

        1. patients who have urticarial for more than 48 hours

        2. have severe underlying disease such as heart disease, kidney disease, liver disease

        3. pregnancy

        4. history of Chlorpheniramine, steroid, antihistamines allergy

        5. history of antihistamine or steroid uses within 48 hours before emergency department
           visit

        6. diabetes mellitus

        7. suspected of more severe disease or severe allergic reaction

        8. patients who don't have pruritus

        9. patients who have history of chronic urticaria

      Informed consent process The doctor who is the principal investigator or his assigned
      colleagues describe the research's details and methods to an enrolled patients. The documents
      which contain the details of the research project are also given. Inform consents then were
      signed before the beginning of the experiment.

      The volunteer would be in a research process during their first 1-2 hours in emergency
      department, with the follow up time at 1 week and 1 month

      After the investigator complete the inclusion and exclusion criteria, the participants would
      be random into 3 groups. The randomization process would already be prepared into 3 groups
      with a number coding by the statistician who doesn't get involve in the rest of experiment.
      The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination
      :

        1. Control group : Chlorpheniramine 10 mg/amp ; 1 ampule and cetirizine 10 mg 7 tabs

        2. Experiment group : Chlorpheniramine 10 mg/amp ; 1 ampule, Dexamethasone 5 mg/amp; 1
           ampule and cetirizine 10 mg 7 tabs

        3. Experiment group : Chlorpheniramine 10 mg/amp ; 1 ampule, Dexamethasone 5 mg/amp; 1
           ampule, cetirizine 10 mg 7 tabs, and prednisolone 5 mg 20 tabs After the envelopes are
           sealed, it will be code in an order of number. All of the enrolled patients will get
           Chlorpheniramine 10 mg intravenous. The patients who are assigned in experiment group
           will get an additional Dexamethasone 5 mg intravenous. The preparation of both drugs
           will be result to be a 10 ml of clear fluid. The control group will get a 10 ml of
           sterile fluid in 10 ml syringe as a placebo. The drugs will be prepared and delivered be
           the nurse who knows about the research process but does not get involved in other
           process of the research.

      After the experiment period in emergency department, all of the enrolled patients will get
      cetirizine 10 mg 7 tabs as a home medication. One experiment group will get prednisolone 5 mg
      20 tabs. They will be appointed to an outpatient department in 1 week and 1 month for the
      follow up of an acute urticarial rash.

      Sample size calculation Investigators do the hypothesis that the experiment groups who get
      both Chlorpheniramine 10 mg and Dexamethasone 5 mg intravenous would have the itch score
      decrease at least 2 points so this experiment wants minimal clinical difference at "2". This
      number got from our expert in immunology and skin disease. The standard deviation for this
      experiment is 2.1 from the previous research. Calculated by G*Power version 3.1 (Dusseldorf,
      Germany) for an independent t-test , two-tailed analysis, alpha error probability = 0.05 and
      power of analysis (1-beta error probability) = 0.90 The sample size for each group is 23
      persons so the patients enroll in this research would be 69 persons.

      Data Collection

        1. Sex and age

        2. Time since the first rash erupt before coming to emergency department (hrs)

        3. %body surface area of rash involved

        4. Urticarial activity score (UAS) before and after treatment

        5. Itch score (Visual analog scale (VAS) score) by letting the patients mark a cross on a
           straight line. The end of the left side of a line represents "0 = no pain at all", and
           the end of the right side of a line represents "10 = the worst pain ever possible". The
           patients aren't allowed to compare the previous VAS score before doing the cross.

        6. Side effect of drugs

        7. Other medicine used as indicated

        8. Patients' satisfaction score

        9. The recurrence of rash 1 week after the rash onset

       10. The recurrence of rash 1 month after the rash onset which will be evaluate by an expert
           in immunology and skin disease.

      Data Analysis and Statistics

      Descriptive statistics : Chi-square Student t-test and paired t-test for data analysis of
      continuous variables (such as itch score (VAS) and pair wise comparison for cumulative
      increase in the proportion of the "responder" over the time

      Statistical significant when p-value < 0.05
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Itch score
time frame: 60 mins
description: letting the patients mark a cross on a straight line. The end of the left side of a line represents "0 = no itch at all", and the end of the right side of a line represents "10 = the worst itch ever possible". The patients aren't allowed to compare the previous VAS score before doing the cross.
measure: Chronic urticaria incidence
time frame: 1 week, 1 month
description: Chronic urticaria incidence after the use of steroid compare with no steroid use in treatment.
measure: Itch score
time frame: 0, 15, 30 mins
description: letting the patients mark a cross on a straight line. The end of the left side of a line represents "0 = no itch at all", and the end of the right side of a line represents "10 = the worst itch ever possible". The patients aren't allowed to compare the previous VAS score before doing the cross.
arm group label: Control group
arm group type: No Intervention
description: Chlorpheniramine 10 mg/amp ; 1 ampule Cetirizine 10 mg 7 tabs once daily (OD) as home medication
arm group label: Experiment 1
arm group type: Experimental
description: Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication
arm group label: Experiment 2
arm group type: Experimental
description: Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication Oral prednisolone 5 mg 20 tabs ; 2*2 po pc as home medication
intervention type: Drug
intervention name: IV Dexamethasone
description: The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 1 and Experiment 2 groups would receive IV Dexamethasone in emergency department (ED).
arm group label: Experiment 1
arm group label: Experiment 2
other name: Decadron
other name: Dexasone
intervention type: Drug
intervention name: Oral prednisolone
description: The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 2 groups would receive IV Dexamethasone in ED and Oral prednisolone as home medication.
arm group label: Experiment 2
other name: Orapred
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pakhawadee Palungwachira, M.D.
role: Principal Investigator
affiliation: King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Urticaria
mesh term: Dexamethasone
mesh term: Prednisolone
sharing ipd: Undecided