<?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>IRCT2015111015446N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-27</date_registration>
      <primary_sponsor>Vice chanceller for research,Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of clinical and Spirometric response between nebulized salbutamol _ magnesium sulfate and nebulized salbutamol alone  in acute asthma attack</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of clinical and Spirometric response between nebulized salbutamol _ magnesium sulfate and nebulized salbutamol alone  in acute asthma attack</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>146</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute attack asthma.</hc_freetext>
      <i_freetext>Intervention 1: 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 20 g / 100CC) 1.5 CC) done. Intervention 2: 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>DR.Hasan Motamed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Golestan Hospital,Golestan street,Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>613573318</zip>
        <telephone>+98 61 3374 3079</telephone>
        <email>Hasan_motamed@yahoo.com</email>
        <affiliation>Emergency Medicine Assistant Professor</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DR.Hasan Motamed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Golestan Hospital,Golestan street,Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>613573318</zip>
        <telephone>+98 61 3374 3079</telephone>
        <email>Hasan_motamed@yahoo.com</email>
        <affiliation>Ahvaz Golestan Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with clinical and para-clinical asthma has been confirmed; age 18 years and maximum 65 years.&#13;
Exclusion criteria: COPD; CHF; pneumonitis, pulmonary disease lightweight, pregnancy, lactation, is febrile, receiving salbutamol 6 hours before the visit.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asthma</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>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 20 g / 100CC) 1.5 CC) done.</i_keyword>
      <i_keyword>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 mu.</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: with 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>Vice chanceller for research,Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-08</approval_date>
        <contact_name>Ethics Committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Research Assistant, Next to central Building, Ahvaz Jundishapur University of Medical Sciences, University town, Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
