<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04402177</url>
  </required_header>
  <id_info>
    <org_study_id>N-172-2018</org_study_id>
    <nct_id>NCT04402177</nct_id>
  </id_info>
  <brief_title>This Study Aim is to Compare the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis as it Was Found That Not All Patients Get Satisfying Therapeutic Effect After Taking Corticosteroids.</brief_title>
  <official_title>Comparing the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Aim of This Work is to Compare the Effect of Oral Methyl Prednisolone on Different&#xD;
      Radiological Patterns of Hypersensitivity Pneumonitis and to Evaluate the Patient's Clinical&#xD;
      and Functional Status After Taking the Required Dose of Methyl Prednisolone. Not All&#xD;
      Hypersensitivity Pneumonitis Patients get the Same Therapeutic Effect after taking&#xD;
      Corticosteroid so by Comparing the Effect of Methyl Prednisolone on Patients With Different&#xD;
      Radiological Pattern we Will be Able to Select the Patient Who Really Need to Take&#xD;
      Corticosteroid and Who Don't so we Will Protect the Patient Who Doesn't Need to Take Oral&#xD;
      Corticosteroids From Its Numerous Side Effects All Patients Will Undergo the Following&#xD;
      Assessment Before and After Taking 0.5 mg/kg/Day of Methyl Prednisolone for 8 Weeks : High&#xD;
      Resolution CT (HRCT) of Chest , Chest X-ray , Spirometry, 6 Minute Walk Test to Evaluate the&#xD;
      Patient's Functional Status and Oximetry to Measure Percentage of Oxygen in Blood&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      hypersensitivity Pneumonitis patients will be divided in two groups : non- fibrotic&#xD;
      hypersensitivity Pneumonitis patients ( nfHP) and fibrotic hypersensitivity Pneumonitis&#xD;
      patients ( fHP), based on HRCT findings.&#xD;
&#xD;
      All patients will undergo the following assessment at the beginning of the study: High&#xD;
      resolution CT (HRCT) of chest , Spirometry to assess forced expiratory volume in 1 second&#xD;
      (FEV1), Forced vital capacity (FVC) and FEV1 to FVC ratio , 6minute walk test , Oximetry to&#xD;
      measure percentage of oxygen in blood. Then all patients took methyl prednisolone 0.5mg/kg&#xD;
      /day orally for 8 weeks .&#xD;
&#xD;
      During the treatment period Pulmonary spirometry will be done every 2 weeks and 6 minute walk&#xD;
      test will be done every 4 weeks as follow up At the end of the treatment period all these&#xD;
      assessments will be repeated to compared the patients functional and clinical statues before&#xD;
      and after taking methylprednisolone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the patient's Spirometry</measure>
    <time_frame>will be measured at time 0 , after 2 weeks , after 4 weeks , after 6 weeks and after 8 weeks of taking methyl prednisolone</time_frame>
    <description>measuring FEV1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the patient's Spirometery</measure>
    <time_frame>will be measured at time 0 , after 2 weeks , after 4 weeks , after 6 weeks and after 8 weeks of taking methyl prednisolone</time_frame>
    <description>measuring FVC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the patient's oximetry</measure>
    <time_frame>will be measured at time 0 and after 8 weeks of taking methyl prednisolone</time_frame>
    <description>measuring percentage of oxygen in blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in &quot;6 min walk test &quot;</measure>
    <time_frame>At time 0 and after 8 weeks of taking methyl prednisolone</time_frame>
    <description>measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Hypersensitivity Pneumonitis</condition>
  <arm_group>
    <arm_group_label>Hypersensitivity Pneumonitis patients showing lung fibrosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hypersensitivity Pneumonitis patients that shows lung fibrosis after CT scan ( fibrotic patients ) methyl prednisolone 0.5mg/kg /day orally for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypersensitivity Pneumonitis patients without lung fibrosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>hypersensitivity Pneumonitis patients that doesn't show lung fibrosis after CT ( non-fibrotic patients ) will be given also methyl prednisolone 0.5mg/kg /day orally for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methyl Prednisolonate</intervention_name>
    <description>Corticosteroid treatment</description>
    <arm_group_label>Hypersensitivity Pneumonitis patients showing lung fibrosis</arm_group_label>
    <arm_group_label>hypersensitivity Pneumonitis patients without lung fibrosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed diagnosis of hypersensitivity pneumonitis.&#xD;
&#xD;
          2. Adults (older than 18 years).&#xD;
&#xD;
          3. Having history of exposure to allergen&#xD;
&#xD;
          4. Steroid naïve patients -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients with respiratory co-morbidities. 2. Patients with other type of interstitial&#xD;
        lung diseases. 3. Patients already taking steroids. 4. Pregnant or nursing female&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hoda salem, Assistant professor</last_name>
    <role>Study Director</role>
    <affiliation>Azhar University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fatma Ahmed T Shalaby</last_name>
    <phone>01004839333</phone>
    <email>Fatmatony242@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Al Kasr Al-iaini</name>
      <address>
        <city>Giza</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>youssef soliman, professor</last_name>
      <phone>01117766220</phone>
      <email>ymasoliman@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Fatma Ahmed Tony Shalaby</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Alveolitis, Extrinsic Allergic</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402177
org study id: N-172-2018
nct id: NCT04402177
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The Aim of This Work is to Compare the Effect of Oral Methyl Prednisolone on Different
      Radiological Patterns of Hypersensitivity Pneumonitis and to Evaluate the Patient's Clinical
      and Functional Status After Taking the Required Dose of Methyl Prednisolone. Not All
      Hypersensitivity Pneumonitis Patients get the Same Therapeutic Effect after taking
      Corticosteroid so by Comparing the Effect of Methyl Prednisolone on Patients With Different
      Radiological Pattern we Will be Able to Select the Patient Who Really Need to Take
      Corticosteroid and Who Don't so we Will Protect the Patient Who Doesn't Need to Take Oral
      Corticosteroids From Its Numerous Side Effects All Patients Will Undergo the Following
      Assessment Before and After Taking 0.5 mg/kg/Day of Methyl Prednisolone for 8 Weeks : High
      Resolution CT (HRCT) of Chest , Chest X-ray , Spirometry, 6 Minute Walk Test to Evaluate the
      Patient's Functional Status and Oximetry to Measure Percentage of Oxygen in Blood
hypersensitivity Pneumonitis patients will be divided in two groups : non- fibrotic
      hypersensitivity Pneumonitis patients ( nfHP) and fibrotic hypersensitivity Pneumonitis
      patients ( fHP), based on HRCT findings.

      All patients will undergo the following assessment at the beginning of the study: High
      resolution CT (HRCT) of chest , Spirometry to assess forced expiratory volume in 1 second
      (FEV1), Forced vital capacity (FVC) and FEV1 to FVC ratio , 6minute walk test , Oximetry to
      measure percentage of oxygen in blood. Then all patients took methyl prednisolone 0.5mg/kg
      /day orally for 8 weeks .

      During the treatment period Pulmonary spirometry will be done every 2 weeks and 6 minute walk
      test will be done every 4 weeks as follow up At the end of the treatment period all these
      assessments will be repeated to compared the patients functional and clinical statues before
      and after taking methylprednisolone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in the patient's Spirometry
time frame: will be measured at time 0 , after 2 weeks , after 4 weeks , after 6 weeks and after 8 weeks of taking methyl prednisolone
description: measuring FEV1
measure: Change in the patient's Spirometery
time frame: will be measured at time 0 , after 2 weeks , after 4 weeks , after 6 weeks and after 8 weeks of taking methyl prednisolone
description: measuring FVC
measure: Change in the patient's oximetry
time frame: will be measured at time 0 and after 8 weeks of taking methyl prednisolone
description: measuring percentage of oxygen in blood
measure: Change in "6 min walk test "
time frame: At time 0 and after 8 weeks of taking methyl prednisolone
description: measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
arm group label: Hypersensitivity Pneumonitis patients showing lung fibrosis
arm group type: Experimental
description: hypersensitivity Pneumonitis patients that shows lung fibrosis after CT scan ( fibrotic patients ) methyl prednisolone 0.5mg/kg /day orally for 8 weeks
arm group label: hypersensitivity Pneumonitis patients without lung fibrosis
arm group type: Active Comparator
description: hypersensitivity Pneumonitis patients that doesn't show lung fibrosis after CT ( non-fibrotic patients ) will be given also methyl prednisolone 0.5mg/kg /day orally for 8 weeks
intervention type: Drug
intervention name: Methyl Prednisolonate
description: Corticosteroid treatment
arm group label: Hypersensitivity Pneumonitis patients showing lung fibrosis
arm group label: hypersensitivity Pneumonitis patients without lung fibrosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: hoda salem, Assistant professor
role: Study Director
affiliation: Azhar University
last name: Fatma Ahmed T Shalaby
phone: 01004839333
email: Fatmatony242@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Fatma Ahmed Tony Shalaby
investigator title: Principle investigator
mesh term: Pneumonia
mesh term: Alveolitis, Extrinsic Allergic
mesh term: Hypersensitivity