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NCT Number: NCT04675619

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

Completed

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Key information

Conditions

Hypersensitivity Pneumonitis Alveolitis, Extrinsic Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eman Shebl

Zagazig, 44555, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral pirfenidone

Drug

Treatment

Standard care

Drug

Treatment

Primary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: Baseline to 6 months

    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.

  2. 6 minutes walking distance

    Time frame: Baseline to 6 months

    The 6-min walk test (6MWT) has gained importance in the assessment of functional exercise capacity in patients with chronic respiratory disease.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2020
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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