<?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>IRCT2016121020024N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-10</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>High dose Rosuvastatin as an adjunctive treatment in acute exacerbation of chronic obstructive pulmonary disease</public_title>
      <acronym></acronym>
      <scientific_title>High dose Rosuvastatin as an adjunctive treatment in acute exacerbation of chronic obstructive pulmonary disease, a randomized double blind clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17770</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic obstructive pulmonary disease with acute exacerbation.</hc_freetext>
      <i_freetext>Intervention 1: The drug group will receive Rosuvastain tablet (Ropixon ®), dose 40 mg, manufactured by Dr. ABIDI PHARMACEUTICAL LABORATORY. The patients will receive the drug, once daily (first dose on the first day of admission), for 14 days. Intervention 2: The placebo group will receive a tablet with exact shape of Rosuvastain tablet provided by  Dr. ABIDI PHARMACEUTICAL LABORATORY. The patients will receive the placebo, once daily (first dose on the first day of admission), for 14 days. The container of the drug and placebo tablets will be in same shape that the researchers, patients and clinicians could not discriminate the drug from placebo.</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. Soheil Peiman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Nafissi's Building, Imamkhomeini hospital complex, Keshavarz blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6693 9922</telephone>
        <email>s-peiman@tums.ac.ir</email>
        <affiliation>Department of Internal medicine, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Soheil Peiman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Nafissi's Building, Imamkhomeini hospital complex, Keshavarz blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6693 9922</telephone>
        <email>s-peiman@tums.ac.ir; soheil_peiman@yahoo.com</email>
        <affiliation>Department of Internal medicine, Tehran university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Inclusion criteria: &#13;
1) hospitalized patients with acute exacerbation of COPD (AECOPD) according to 2 of following symptoms: Dyspnea, increased sputum and/or purulent sputum;&#13;
2) Age &gt; 40;&#13;
3)Previous Spirometry or clinical history compatible with COPD.&#13;
&#13;
- Exclusion criteria: &#13;
1) Acute coronary syndrome; &#13;
2) history of statin therapy;   &#13;
3)endotracheal  intubation;    &#13;
4) significant associated comorbidities (cardiac, renal or hepatic);    &#13;
5) history of musculoskeletal disorders;  &#13;
6) history of intolerance to statins.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease with acute exacerbation, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The drug group will receive Rosuvastain tablet (Ropixon ®), dose 40 mg, manufactured by Dr. ABIDI PHARMACEUTICAL LABORATORY. The patients will receive the drug, once daily (first dose on the first day of admission), for 14 days.</i_keyword>
      <i_keyword>The placebo group will receive a tablet with exact shape of Rosuvastain tablet provided by  Dr. ABIDI PHARMACEUTICAL LABORATORY. The patients will receive the placebo, once daily (first dose on the first day of admission), for 14 days. The container of the drug and placebo tablets will be in same shape that the researchers, patients and clinicians could not discriminate the drug from placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In hospital mortality. Timepoint: ِduring hospitalization. Method of measurement: monitoring of the patients' clinical status.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: during patients' hospital stay. Method of measurement: time period of hospitalization in days.</prim_outcome>
      <prim_outcome>Recurrencof acute COPD exacerbation. Timepoint: Within 3 months after taking meication. Method of measurement: Telephone follow-up.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>COPD Assessment Test (CAT) questionnaire, persian version. Timepoint: in 1st and 3rd day after initiation of medication. Method of measurement: COPD Assessment Test (CAT) questionnaire score.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation of hemoglobin. Timepoint: in 1st and 3rd day of taking medication. Method of measurement: Pulse oximeter - Beurer GmbH.</sec_outcome>
      <sec_outcome>Arterial PCO2. Timepoint: in 1st and 3rd day of taking medication. Method of measurement: VL 995 blood gas analyzer.</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, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-16</approval_date>
        <contact_name>Ethics committe of Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor,Vice Chancellor for Research, Tehran University of Medical Sciences central building, Keshavarz blvd. Ghods street. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
