Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis
NCT ID: NCT04675619
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2019-12-01
2020-06-30
Brief Summary
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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
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Oral pirfenidone
Treatment
Standard care
Standard care
Standard care
Treatment
Interventions
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Oral pirfenidone
Treatment
Standard care
Treatment
Eligibility Criteria
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Inclusion Criteria
* \>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
* 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
18 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Eman Shebl
Assistant professor
Locations
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Eman Shebl
Zagazig, , Egypt
Countries
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References
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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.
Other Identifiers
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5889
Identifier Type: -
Identifier Source: org_study_id