Clinical trial NCT04675619: Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis
Official title: Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypersensitivity Pneumonitis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline to 6 months
measure: 6 minutes walking distance
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Eman Shebl
Study officials:
References:
citation: 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.
citation: 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.