Characterizing disease progression in hypersensitivity pneumonitis

HypErsensitiVity PneumonITis: DiseAse Progression Characterization. An International Multicentric Prospective Observational Study

This study is trying to understand how chronic hypersensitivity pneumonitis changes over time in people from Latin America by looking at different types of the disease and how it affects lung function.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Hospital do Coracao (other)
• Locations: 10 sites (Bueno Aires and 9 other locations)
• Trial ID: NCT04961944 on ClinicalTrials.gov

What this trial studies

This observational study, known as EVITA, is a multicentric prospective cohort focused on chronic hypersensitivity pneumonitis in Latin America. The primary aim is to identify different phenotypes and endotypes associated with disease progression, primarily measured by forced vital capacity (FVC) over a 24-month follow-up period. Secondary measures will include imaging studies, time to death or lung transplantation, and patient-reported outcomes to provide a comprehensive understanding of the disease trajectory.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with hypersensitivity pneumonitis within the last 24 months and exhibiting radiological or histological fibrosis.

Not a fit: Patients with established connective tissue diseases, severe respiratory comorbidities, or those requiring supplemental oxygen at rest may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of hypersensitivity pneumonitis, potentially improving patient outcomes.

How similar studies have performed: While the approach of characterizing disease progression in hypersensitivity pneumonitis is not widely tested, similar studies in interstitial lung diseases have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Adult outpatient subjects (18 years old or older) that fulfill the 2020 ATS/JRS/ALAT diagnostic criteria of HP of at least moderate confidence (70% confidence or more).
2. Willingness to undergo the evaluations proposed in this protocol
3. HP diagnosis within the last 24 months
4. Presence of radiological or histological fibrosis:

4.a. Radiological fibrosis consists of unequivocal fine or coarse reticulation with architectural lung distortion and/or traction bronchiectasis and/or honeycomb.

4.b. Unequivocal histopathological fibrosis evidenced on lung specimens

Exclusion Criteria:

1. Pregnancy
2. Presence of established connective tissue disease
3. Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
4. Use of supplemental oxygen at rest
5. Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing)
6. Unequivocal emphysematous pattern of HP on HRCT
7. Unequivocal pleuro-parenchymal fibroelastosis on the HRCT
8. Significant pulmonary arterial hypertension:

8.a. Signs of right ventricular failure by echodopplercardiogram or 8.b. Cardiac index \< 2L/min/m2 or right heart catheterism

Where this trial is running

Bueno Aires and 9 other locations

• Hospital Prov de Tórax Dr. A. Cetrángolo — Bueno Aires, Argentina (ACTIVE_NOT_RECRUITING)
• Instituto de Rehabilitacion Psicofisica — Buenos Aires, Argentina (ACTIVE_NOT_RECRUITING)
• University of Buenos Aires — Buenos Aires, Argentina (ACTIVE_NOT_RECRUITING)
• LABOX - Federal University of Santa Catarina — Santa Catarina, SC, Brazil (ACTIVE_NOT_RECRUITING)
• LAPOGE - Federal University of Santa Catarina — Santa Catarina, SC, Brazil (ACTIVE_NOT_RECRUITING)
• University Hospital HU Professor Polydoro - Federal University of Santa Catarina — Florianópolis, Brazil (ACTIVE_NOT_RECRUITING)
• Centro EDUMED — Paraná, Brazil (ACTIVE_NOT_RECRUITING)
• Hospital do Servidor Estadual de Sao Paulo (IAMPSE) — Sao Paulo, Brazil (RECRUITING)
• InCor - Medical School of the University of Sao Paulo — Sao Paulo, Brazil (NOT_YET_RECRUITING)
• Instituto Nacional del Tórax — Santiago, Chile (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Leticia Kawano Dourado, MD — HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
• Study coordinator: Leticia Kawano-Dourado (PI), MD

Conditions: Hypersensitivity Pneumonitis, hypersensitivity pneumonitis, pulmonary fibrosis, interstitial lung disease