<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20151103024853N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-15</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Assessment and comparison of two standard protocols for management of asthma attack</public_title>
      <acronym></acronym>
      <scientific_title>Assessment and comparison of two standard protocols for management of asthma attack in patients admitted to Imam Khomeini and Golestan Hospitals emergency rooms in Ahwaz, Iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30618</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients to be coding in bases of table of random number, then divide to two groups, Blinding description: Patients, research fellow and evaluator of events kept blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute asthma attack.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol dose (2.5 mg), as well as magnesium sulfate 2.5 CC Of 20 g / 100CC done. Intervention 2: Control group: the control group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol 2 / 5CC (2.5 mg), with 1.5 CC of saline in the control group will receive.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Leila Kouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Faculty of Pharmacy, Golestan street, Ahvaz</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8380</telephone>
        <email>lkouti.pharmacotherapy@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Leila Kouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Faculty of Pharmacy, Golestan street, Ahvaz</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8380</telephone>
        <email>lkouti.pharmacotherapy@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with clinical and para clinical approved asthma with clinical presentation of acute asthma attack
Age: minimum 18 years old and maximum 65 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>COPD
CHF
Pneumonia
Lung disease
Nursing mothers
Fever
Pregnancy
Administration of salbutamol in the last 6 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45.901</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified asthma with (acute) exacerbation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the intervention group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol dose (2.5 mg), as well as magnesium sulfate 2.5 CC Of 20 g / 100CC done.</i_keyword>
      <i_keyword>Control group: the control group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol 2 / 5CC (2.5 mg), with 1.5 CC of saline in the control group will receive.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical state. Timepoint: Before intervention, 20, 40, 60 minutes after intervention. Method of measurement: Base on alert status, talking, wizing, use of respiratory muscles.</prim_outcome>
      <prim_outcome>Forced Expiratory Volum in First Secend (FEV1). Timepoint: Before intervention, 20, 40, 60 minutes after intervention. Method of measurement: Mililiter with use of Peak Flow Meter.</prim_outcome>
      <prim_outcome>Peak Expiratory Flow Rate(PEFR). Timepoint: Before intervention, 20, 40, 60 minutes after intervention. Method of measurement: Mililiter with use of Peak Flow Meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before intervention, 20, 40, 60 minutes after intervention. Method of measurement: mm Hg.</sec_outcome>
      <sec_outcome>Pulse Rate. Timepoint: Before intervention, 20, 40, 60 minutes after intervention. Method of measurement: Rate/Minutes.</sec_outcome>
      <sec_outcome>Respiratory Rate. Timepoint: Before intervention, 20, 40, 60 minutes after intervention. Method of measurement: Rate/Minutes.</sec_outcome>
      <sec_outcome>Saturation of arterial blood oxygen (SO2 %). Timepoint: Before intervention, 20, 40, 60 minutes after intervention. Method of measurement: Pulse Oximetry.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-05</approval_date>
        <contact_name>Ethics committee of ahvaz University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences, Golestan blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
