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.

Hypersensitivity Pneumonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402177
• Other study ID #: N-172-2018
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2020
• Source: Al-Azhar University
• Contact: Fatma Ahmed T Shalaby
• Phone: 01004839333
• Email: Fatmatony242[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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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Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Pneumonia

Intervention

Drug:
• Methyl Prednisolonate
Corticosteroid treatment

Locations

Country	Name	City	State
Egypt	Al Kasr Al-iaini	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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