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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.

Primary Purpose

Hypersensitivity Pneumonitis

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Methyl Prednisolonate
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity Pneumonitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Al Kasr Al-iainiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypersensitivity Pneumonitis patients showing lung fibrosis

hypersensitivity Pneumonitis patients without lung fibrosis

Arm Description

hypersensitivity Pneumonitis patients that shows lung fibrosis after CT scan ( fibrotic patients ) methyl prednisolone 0.5mg/kg /day orally for 8 weeks

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

Outcomes

Primary Outcome Measures

Change in the patient's Spirometry
measuring FEV1
Change in the patient's Spirometery
measuring FVC
Change in the patient's oximetry
measuring percentage of oxygen in blood
Change in "6 min walk test "
measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface

Secondary Outcome Measures

Full Information

First Posted
May 21, 2020
Last Updated
May 22, 2020
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04402177
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.
Official Title
Comparing the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity Pneumonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypersensitivity Pneumonitis patients showing lung fibrosis
Arm Type
Experimental
Arm Description
hypersensitivity Pneumonitis patients that shows lung fibrosis after CT scan ( fibrotic patients ) methyl prednisolone 0.5mg/kg /day orally for 8 weeks
Arm Title
hypersensitivity Pneumonitis patients without lung fibrosis
Arm Type
Active Comparator
Arm 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(s)
Methyl Prednisolonate
Intervention Description
Corticosteroid treatment
Primary Outcome Measure Information:
Title
Change in the patient's Spirometry
Description
measuring FEV1
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
Title
Change in the patient's Spirometery
Description
measuring FVC
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
Title
Change in the patient's oximetry
Description
measuring percentage of oxygen in blood
Time Frame
will be measured at time 0 and after 8 weeks of taking methyl prednisolone
Title
Change in "6 min walk test "
Description
measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Time Frame
At time 0 and after 8 weeks of taking methyl prednisolone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of hypersensitivity pneumonitis. Adults (older than 18 years). Having history of exposure to allergen 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Ahmed T Shalaby
Phone
01004839333
Email
Fatmatony242@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hoda salem, Assistant professor
Organizational Affiliation
Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
Al Kasr Al-iaini
City
Giza
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
youssef soliman, professor
Phone
01117766220
Email
ymasoliman@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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.

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