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.

Overview

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

Full Title of Study: “Comparing the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 1, 2021

Detailed Description

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.

Interventions

  • Drug: Methyl Prednisolonate
    • Corticosteroid treatment

Arms, Groups and Cohorts

  • Experimental: Hypersensitivity Pneumonitis patients showing lung fibrosis
    • hypersensitivity Pneumonitis patients that shows lung fibrosis after CT scan ( fibrotic patients ) methyl prednisolone 0.5mg/kg /day orally for 8 weeks
  • Active Comparator: hypersensitivity Pneumonitis patients without lung fibrosis
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • measuring FEV1
  • 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
    • measuring FVC
  • Change in the patient’s oximetry
    • Time Frame: will be measured at time 0 and after 8 weeks of taking methyl prednisolone
    • measuring percentage of oxygen in blood
  • Change in “6 min walk test “
    • Time Frame: At time 0 and after 8 weeks of taking methyl prednisolone
    • measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface

Participating in This Clinical Trial

Inclusion Criteria

1. Confirmed diagnosis of hypersensitivity pneumonitis.

2. Adults (older than 18 years).

3. Having history of exposure to allergen

4. Steroid naïve patients

Exclusion Criteria

1. Patients with respiratory co-morbidities. 2. Patients with other type of interstitial lung diseases. 3. Patients already taking steroids. 4. Pregnant or nursing female

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Al-Azhar University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fatma Ahmed Tony Shalaby, Principle investigator – Al-Azhar University
  • Overall Official(s)
    • hoda salem, Assistant professor, Study Director, Azhar university
  • Overall Contact(s)
    • Fatma Ahmed T Shalaby, 01004839333, Fatmatony242@gmail.com

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