Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

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

Study Overview

• Status: Completed
• Conditions: Hypersensitivity Pneumonitis
• Intervention / Treatment: Drug: Oral pirfenidone; Drug: Standard care

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

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44555
    • Eman Shebl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral pirfenidone; 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; Treatment
Experimental: Standard care	Drug: Standard care; Treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Respiratory Hypersensitivity; Lung Diseases, Interstitial; Hypersensitivity; Pneumonia; Alveolitis, Extrinsic Allergic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: 5889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No