A Phase 2 interventional study of Oral pirfenidone and Standard care in Hypersensitivity Pneumonitis, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Zagazig University · Phase 2, Interventional, and Treatment
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
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
This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis.
Objectives
Study design An interventional randomized controlled study
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 40 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
Drug: Standard care
Treatment
Treatment
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.
Time frame: 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.
Time frame: Baseline to 6 months
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Zagazig University