Hypersensitivity Pneumonitis
Conditions
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
Interventions
DRUGOral pirfenidone
Treatment
DRUGStandard care
Treatment
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity (FVC) | Baseline to 6 months | 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. |
| 6 minutes walking distance | Baseline to 6 months | The 6-min walk test (6MWT) has gained importance in the assessment of functional exercise capacity in patients with chronic respiratory disease. |
Countries
Egypt
Outcome results
None listed