<?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>IRCT2016052828129N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-05</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Alprostadil on improvement of acute asthma attack</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of Alprostadil administration with routine cares on improvement of forced expiratory volume in 1 second, peak expiratory flow rates and clinical indexes of patients with acute asthma attack</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22886</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Patients in intervention will receive 2 mcg/kg/min intravenous Alprostadil and Albuterol with 20 minutes interval in three dosages via inhalation. Intervention 2: Patients in control group will receive treatment based on their asthma attack severity. In mild to moderate attacks, patients will receive 2.5 mg Albuterol and 0.5 mg Ipratropium Bromide via inhalation with 20 minutes interval in three dosages. Patients with severe asthma attack will receive 5 mg Albuterol and 0.5 mg Ipratropium Bromide via inhalation with 20 minutes interval in three dosages, and will receive Prednisolone via oral.</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>Azin Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8255</telephone>
        <email>azin.moradi56@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Motamed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8255</telephone>
        <email>Hassan_motamed@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age range of 18 to 65 years; proved diagnosis of asthma based on primary outcomes (wheezing, cough, and breathlessness triad). &#13;
Exclusion criteria: pulmonary diseases similar to asthma (such as interstitial lung disease)؛ having proven coagulation disorders and being treated with anticoagulants؛  history of chronic bronchitis; having acute medical disorders, cardiac, coronary vascular and arrhythmia diseases؛ being pregnant; treating with beta agonist nebulizers during last 6 hours, using cigarette more than 10 packs in year.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed 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>Patients in intervention will receive 2 mcg/kg/min intravenous Alprostadil and Albuterol with 20 minutes interval in three dosages via inhalation.</i_keyword>
      <i_keyword>Patients in control group will receive treatment based on their asthma attack severity. In mild to moderate attacks, patients will receive 2.5 mg Albuterol and 0.5 mg Ipratropium Bromide via inhalation with 20 minutes interval in three dosages. Patients with severe asthma attack will receive 5 mg Albuterol and 0.5 mg Ipratropium Bromide via inhalation with 20 minutes interval in three dosages, and will receive Prednisolone via oral.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Forced expiratory volume in 1 second. Timepoint: Before intervention and in 20, 40, and 60 minutes after intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Peak expiratory flow rate. Timepoint: Before intervention and in 20, 40, and 60 minutes after intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Clinical symptoms severity. Timepoint: Before intervention and  40 minutes after intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Before intervention and 40 minutes after intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Pulse rate. Timepoint: Before intervention and 40 minutes after intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Blood pressure rate. Timepoint: Before intervention and 40 minutes after intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Atrial oxygen saturation. Timepoint: Before intervention and 40 minutes after intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Level of consciousness. Timepoint: Before intervention and 40 minutes after intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Wheezing. Timepoint: Before intervention and 40 minutes after intervention. Method of measurement: Borg dyspnea scale.</sec_outcome>
      <sec_outcome>Using respiratory peripheral muscles. Timepoint: Before intervention and 40 minutes after intervention. Method of measurement: Borg dyspnea scale.</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 chancellor for research, Ahwaz Judishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-26</approval_date>
        <contact_name>Ethics Committee of Ahwaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
