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.

NCT04402177 | Unknown Phase 4 FDA Drug

• 1 other identifier: N-172-2018
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Hypersensitivity Pneumonitis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Hypersensitivity Pneumonitis patients showing lung fibrosis

EXPERIMENTAL

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

hypersensitivity Pneumonitis patients without lung fibrosis

ACTIVE COMPARATOR

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

Interventions

Methyl Prednisolonate DRUG

Corticosteroid treatment

Hypersensitivity Pneumonitis patients showing lung fibrosis; hypersensitivity Pneumonitis patients without lung fibrosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of hypersensitivity pneumonitis.
• Adults (older than 18 years).
• Having history of exposure to allergen
• Steroid naïve patients -

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Kasr Al-iaini

Giza, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Interventions

methyl prednisolonate

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• hoda salem, Assistant professor

  Al-Azhar University

  STUDY DIRECTOR

Central Study Contacts

Fatma Ahmed T Shalaby

CONTACT

01004839333; Fatmatony242@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 26, 2020
• Study Start: July 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

EG (1)