Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

Conditions
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Hypersensitivity Pneumonitis

Intervention / Treatment
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* Drug: Oral pirfenidone
* Drug: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral pirfenidone<br>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. | Drug: Oral pirfenidone<br>* Treatment<br>|
| Experimental: Standard care<br>Standard care | Drug: Standard care<br>* Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 6 months | 
| 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. | Baseline to 6 months |