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.

Comparing the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis

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

Study Overview

• Status: Unknown
• Conditions: Hypersensitivity Pneumonitis
• Intervention / Treatment: Drug: Methyl Prednisolonate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fatma Ahmed T Shalaby; Phone Number: 01004839333; Email: Fatmatony242@gmail.com

Study Locations

• Egypt
  • Giza, Egypt, 11562
    • Recruiting
    • Al Kasr Al-iaini
    • Contact: youssef soliman, professor; Phone Number: 01117766220; Email: ymasoliman@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Methyl Prednisolonate; Corticosteroid treatment
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	Drug: Methyl Prednisolonate; Corticosteroid treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the patient's Spirometry	measuring FEV1	will be measured at time 0 , after 2 weeks , after 4 weeks , after 6 weeks and after 8 weeks of taking methyl prednisolone
Change in the patient's Spirometery	measuring FVC	will be measured at time 0 , after 2 weeks , after 4 weeks , after 6 weeks and after 8 weeks of taking methyl prednisolone
Change in the patient's oximetry	measuring percentage of oxygen in blood	will be measured at time 0 and after 8 weeks of taking methyl prednisolone
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	At time 0 and after 8 weeks of taking methyl prednisolone

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: hoda salem, Assistant professor, Azhar University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (ACTUAL): May 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Respiratory Hypersensitivity; Lung Diseases, Interstitial; Hypersensitivity; Pneumonia; Alveolitis, Extrinsic Allergic
• Other Study ID Numbers: N-172-2018

Drug and device information, study documents

• 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