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Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

Primary Purpose

Hypersensitivity Pneumonitis

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Oral pirfenidone
Standard care
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity Pneumonitis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients ≥ 18 years old with a diagnosis of chronic progressive Hypersensitivity pneumonitis:
  • >10% extent of fibrosis (eg, reticulation) on high-resolution CT (HRCT) scan
  • Absolute decline in FVC% predicted >5% within the previous 6 months despite conventional treatment.

Exclusion Criteria:

  • Pregnancy or breastfeeding period
  • Patients with peptic ulcer, severe hepatic disease, severe kidney disease, severe cardiac disease, and patients with other chronic pulmonary diseases.
  • Presence of active infection
  • History of alcohol or drugs abuse
  • Active smokers

Sites / Locations

  • Eman Shebl

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oral pirfenidone

Standard care

Arm Description

Pirfenidone will be administered orally in 267 mg capsules taken with food. The dose will be titrated over 2 weeks from one capsule three times a day during Week 1 to two capsules three times a day during Week 2 then maintenance dose (three capsules three times a day Week 3.

Standard care

Outcomes

Primary Outcome Measures

Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration,. FVC is the most basic maneuver in spirometry tests.
6 minutes walking distance
The 6-min walk test (6MWT) has gained importance in the assessment of functional exercise capacity in patients with chronic respiratory disease.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2020
Last Updated
December 15, 2020
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04675619
Brief Title
Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis
Official Title
Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis. This study included 40 adult patients (≥ 18 years) with a diagnosis of chronic progressive hypersensitivity pneumonitis. The included patients were divided into 2 groups 20 patients in each one. Group 1: will receive pirfenidone in addition to the conventional treatment Group 2: will be maintained on conventional treatment. Forced vital capacity (FVC),6 minutes walking test(6MWT), oxygen tension in the arterial blood (PaO2), and St. George's Respiratory Questionnaire (SGRQ ) were measured before and after 6 months of a pirfenidone treatment trial. Results
Detailed Description
Rationale The present data about the treatment of CHP are few and largely based on observational studies and expert opinion. It is suggested that pirfenidone may slow disease progression in cases of CHP as it has some anti-inflammatory in addition to antifibrotic effects. Hypothesis Pirfenidone will slow disease progression in hypersensitivity pneumonitis patients Research questions Can pirfenidone slow disease progression in cases of CHP? What about the safety of pirfenidone in cases of CHP? This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis. Objectives To compare the functional and radiological parameters between patients group who receive pirfenidone treatment and the patient group who receive conventional treatment: FVC, 6 minutes walking distance, the partial pressure of oxygen in arterial blood ( PaO2), Pulmonary artery systolic pressure, St.George's Respiratory Questionnaire(SGRQ Score) and Quantitative ILD score (QILD), by quantitative HRCT chest. To compare the side effects between patients' group who receive pirfenidone treatment and the patient group who receive placebo treatment Study design An interventional randomized controlled study

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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral pirfenidone
Arm Type
Experimental
Arm Description
Pirfenidone will be administered orally in 267 mg capsules taken with food. The dose will be titrated over 2 weeks from one capsule three times a day during Week 1 to two capsules three times a day during Week 2 then maintenance dose (three capsules three times a day Week 3.
Arm Title
Standard care
Arm Type
Experimental
Arm Description
Standard care
Intervention Type
Drug
Intervention Name(s)
Oral pirfenidone
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
Standard care
Intervention Description
Treatment
Primary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration,. FVC is the most basic maneuver in spirometry tests.
Time Frame
Baseline to 6 months
Title
6 minutes walking distance
Description
The 6-min walk test (6MWT) has gained importance in the assessment of functional exercise capacity in patients with chronic respiratory disease.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years old with a diagnosis of chronic progressive Hypersensitivity pneumonitis: >10% extent of fibrosis (eg, reticulation) on high-resolution CT (HRCT) scan Absolute decline in FVC% predicted >5% within the previous 6 months despite conventional treatment. Exclusion Criteria: Pregnancy or breastfeeding period Patients with peptic ulcer, severe hepatic disease, severe kidney disease, severe cardiac disease, and patients with other chronic pulmonary diseases. Presence of active infection History of alcohol or drugs abuse Active smokers
Facility Information:
Facility Name
Eman Shebl
City
Zagazig
ZIP/Postal Code
44555
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30578335
Citation
Cottin V, Hirani NA, Hotchkin DL, Nambiar AM, Ogura T, Otaola M, Skowasch D, Park JS, Poonyagariyagorn HK, Wuyts W, Wells AU. Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. Eur Respir Rev. 2018 Dec 21;27(150):180076. doi: 10.1183/16000617.0076-2018. Print 2018 Dec 31.
Results Reference
background
PubMed Identifier
27615411
Citation
Li T, Guo L, Chen Z, Gu L, Sun F, Tan X, Chen S, Wang X, Ye S. Pirfenidone in patients with rapidly progressive interstitial lung disease associated with clinically amyopathic dermatomyositis. Sci Rep. 2016 Sep 12;6:33226. doi: 10.1038/srep33226.
Results Reference
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Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

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