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
About this trial
This is an interventional treatment trial for Hypersensitivity Pneumonitis
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
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
NCT ID
NCT04675619
First Posted
December 11, 2020
Last Updated
December 15, 2020
Sponsor
Zagazig University
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
background
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Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis
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