<?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>IRCT138903114085N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2008-02-20</date_registration>
      <primary_sponsor>Research assistant of Guilan University of Medical Science</primary_sponsor>
      <public_title>Effects of atorvastatin on asthmatic patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of atorvastatin on lung function in asthmatic patients under treatment with high dose inhaled steroid or oral steroid</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4275</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Atrovastatin 40mg tablet, daily, for 8 weeks. Intervention 2: Placebo 40mg tablet, daily, for 8 weeks.</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>Seyyed Ali Alavi Foumani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Jangal street, Razi hospital</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448-95655</zip>
        <telephone>+98 13 1554 1001</telephone>
        <email>rrc@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Nejatifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi hospital, Sardar Jangal street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448-95655</zip>
        <telephone>+98 13 1554 1001</telephone>
        <email>dr_f_nejatifar@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: aged 18 to 70 years, moderate to severe persistent asthma, under maintenance  therapy with high dose inhaled corticosteroid and any dose of oral corticosteroid, under stable medication for the four preceding weeks before randomization, being admitted to respiratory clinic of Razi medical center (Rasht, Guilan province)&#13;
Exclusion criteria: current smoking or ex-smoking more than 5 pack–year, pregnancy, lactation, any associated diseases, receiving statins or any statin interacting drugs, occurrence of any asthmatic attack during the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Atrovastatin 40mg tablet, daily, for 8 weeks</i_keyword>
      <i_keyword>Placebo 40mg tablet, daily, for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FEV1. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>FVC. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>FEV1/FVC. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>FEF25-75%. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: blood sample,micg/ml.</prim_outcome>
      <prim_outcome>ESR. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: blood sample, mm/h.</prim_outcome>
      <prim_outcome>Asthma control level. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: asthma control test (ACT).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Creatinine kinase(CPK). Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: blood sample, IU/L.</sec_outcome>
      <sec_outcome>Liver function test. Timepoint: at the begining of the study and every 1-month interval until 2months. Method of measurement: blood sample,IU/L.</sec_outcome>
      <sec_outcome>(Beta hCG) pregnancy test. Timepoint: at the begining of the study and every 1 month interval until 2 months. Method of measurement: blood sample, mIU/ml.</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>Research assistant of Guilan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-05-21</approval_date>
        <contact_name>Vice-chancellor for Research, Guilan university of medical sciences</contact_name>
        <contact_address>Vice-chancellor for Research building, Shahid Siadati street, Namjoo avenue, Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
