Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

NCT04675619 | Completed Phase 2

• 1 other identifier: 5889
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hypersensitivity Pneumonitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Oral pirfenidone

EXPERIMENTAL

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

Standard care

EXPERIMENTAL

Standard care

Drug: Standard care

Interventions

Oral pirfenidone DRUG

Treatment

Oral pirfenidone

Standard care DRUG

Treatment

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Eman Shebl

Zagazig, 44555, Egypt

Location

Related Publications (2)

• 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.

  PMID: 30578335 BACKGROUND

• 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.

  PMID: 27615411 BACKGROUND

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Interventions

pirfenidone; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 19, 2020
• Study Start: December 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)