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.

• Sponsor: Al-Azhar University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04402177
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 9.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hypersensitivity Pneumonitis	Drug: Methyl Prednisolonate	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparing the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis
• Anticipated Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in the patient's Spirometry [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

2. Change in the patient's Spirometery [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

3. Change in the patient's oximetry [will be measured at time 0 and after 8 weeks of taking methyl prednisolone]

   measuring percentage of oxygen in blood

4. Change in "6 min walk test " [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Kasr Al-iaini	Giza		Egypt	11562

Sponsors and Collaborators

• Al-Azhar University

Investigators

• Study Director: hoda salem, Assistant professor, Azhar university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatma Ahmed Tony Shalaby, Principle investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT04402177
• Other Study ID Numbers: N-172-2018
• First Posted: May 26, 2020
• Last Update Posted: May 26, 2020
• Last Verified: May 1, 2020

• 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
• Additional relevant MeSH terms: Pneumonia; Alveolitis, Extrinsic Allergic; Hypersensitivity

Study Results

No Results Posted as of May 26, 2020