Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

Zagazig University

Status and phase: Completed; Phase 2

Conditions: Hypersensitivity Pneumonitis

Treatments: Drug: Oral pirfenidone; Drug: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04675619

5889

Details and patient eligibility

About

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

Full 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

1. Can pirfenidone slow disease progression in cases of CHP?
2. What about the safety of pirfenidone in cases of CHP?

This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis.

Objectives

1. 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.
2. 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Oral pirfenidone

Experimental group

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.

Treatment:

Drug: Oral pirfenidone

Standard care

Experimental group

Description:

Standard care

Treatment:

Drug: Standard care