Evaluation of the Efficacy of Pirfenidone in Progressive Chronic

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04675619
Study type	Interventional
Source	Zagazig University
Contact
Status	Completed
Phase	Phase 2
Start date	December 1, 2019
Completion date	June 30, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms