Hypersensitivity PneumonitisEVITANCT04961944
HypErsensitiVity PneumonITis: DiseAse Progression Characterization
An observational study of Hypersensitivity Pneumonitis, run by Hospital do Coracao at 10 sites in 3 countries.
Trial summary
EVITA is a multicentric Latin-American prospective cohort on chronic hypersensitivity pneumonitis. EVITA's objective is to identify phenotypes and/or endotypes associated with different disease trajectories measured primarily by forced vital capacity (FVC) during a 24 month follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypersensitivity Pneumonitis
- What is being tested?
- Disease assessment
- How many people
- 150 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 20 Jun 2022to 1 Mar 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chronic (fibrotic) hypersensitivity pneumonitis
Who may be able to join
- 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).
- Willingness to undergo the evaluations proposed in this protocol
- HP diagnosis within the last 24 months
- 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
Who cannot join
- Pregnancy
- Presence of established connective tissue disease
- Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
- Use of supplemental oxygen at rest
- Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing)
- Unequivocal emphysematous pattern of HP on HRCT
Show all 9Show fewer
- Unequivocal pleuro-parenchymal fibroelastosis on the HRCT
- 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
Trial locations and contacts
10 sites in 3 countries.
Samara Pinheiro (Project Manager) contact
10 sites in 3 countries
Brazil6 sites, 2 recruiting
- Active, not recruiting
University Hospital HU Professor Polydoro - Federal University of Santa Catarina
Florianópolis
- Active, not recruiting
Centro EDUMED
Paraná
- Active, not recruiting
LABOX - Federal University of Santa Catarina
Santa Catarina, Santa Catarina
- Active, not recruiting
LAPOGE - Federal University of Santa Catarina
Santa Catarina, Santa Catarina
- Recruiting
Hospital do Servidor Estadual de Sao Paulo (IAMPSE)
São Paulo
Silvia Rodrigues, MD
- Not yet recruiting
InCor - Medical School of the University of Sao Paulo
São Paulo
Fabio Arimura, MD
Argentina3 sites
- Active, not recruiting
Hospital Prov de Tórax Dr. A. Cetrángolo
Bueno Aires
- Active, not recruiting
Instituto de Rehabilitacion Psicofisica
Buenos Aires
- Active, not recruiting
University of Buenos Aires
Buenos Aires
Chile1 site, 1 recruiting
- Not yet recruiting
Instituto Nacional del Tórax
Santiago
Felipe Reyes, MD
Matias Florenzano, MD
About this study
Official title: HypErsensitiVity PneumonITis: DiseAse Progression Characterization. An International Multicentric Prospective Observational Study
EVITA is a multicentric Latin-American prospective cohort on chronic hypersensitivity pneumonitis. EVITA's objective is to identify phenotypes and/or endotypes associated with different disease trajectories measured primarily by forced vital capacity (FVC) during a 24 month follow-up period. Other secondary measures of disease progression will also be investigated such as imaging, time to death or lung transplantation, and patient-reported outcomes
- Conditions
- Hypersensitivity Pneumonitis
- Being tested
- Disease assessment
- Keywords
- hypersensitivity pneumonitis, pulmonary fibrosis, interstitial lung disease
- Medical subject headings
- Alveolitis, Extrinsic Allergic, Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease assessmentOther
Also called Pulmonary function test (PFT), High Resolution Computed Tomography (HRCT) of the Chest, 6-minute walking distance (6MWD), blood for genomics, functional genomics and protein biomarker analysis
A comprehensive evaluation of the disease's extension, its impact on function, quality of life, and the search for phenotype/endotypes will be performed.
The association between endotypes and disease progression will be tested.
| Study group | Role | What they receive |
|---|---|---|
| Hypersensitivity pneumonitis | see elegibility criteria Receives: Other: Disease assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Forced Vital Capacity (FVC) as a continuous variable
Measured: 24 months
Secondary outcomes (4)
Variation in Computed Tomography Lung Densitometry
Measured: 24 months
Time to death or lung transplantation
Measured: 24 months
Acute exacerbation rate
Measured: 24 months
King´s Brief Interstitial Lung Disease Questionnaire (K-BILD)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start20 Jun 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Centro Rossi, Buenos Aires, Argentina
- Responsible party
- Sponsor
- Investigators
- Leticia Kawano Dourado, MD, Principal investigator, HCOR Research Institute, Hospital do Coracao, São Paulo, BrazilProf. Alexandra Latini, PhD, Study chair, Federal University of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961944
- Sponsor's protocol ID
- EVITA BI 1199-0430
- Acronym
- EVITA
- Status last verified
- Jun 2023
- First submitted
- 5 Jul 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HypErsensitiVity PneumonITis: DiseAse Progression Characterization. An International Multicentric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04961944
- Acronym / sponsor ID
- EVITA / EVITA BI 1199-0430
- Conditions
- Hypersensitivity Pneumonitis
- Keywords
- hypersensitivity pneumonitis, pulmonary fibrosis, interstitial lung disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Centro Rossi, Buenos Aires, Argentina
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EVITA is a multicentric Latin-American prospective cohort on chronic hypersensitivity pneumonitis. EVITA's objective is to identify phenotypes and/or endotypes associated with different disease trajectories measured primarily by forced vital capacity (FVC) during a 24 month follow-up period. Other secondary measures of disease progression will also be investigated such as imaging, time to death or lung transplantation, and patient-reported outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypersensitivity pneumonitis | – | Other: Disease assessmentsee elegibility criteria |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic (fibrotic) hypersensitivity pneumonitis
Key inclusion criteria (6 listed)
- 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).
- Willingness to undergo the evaluations proposed in this protocol
- HP diagnosis within the last 24 months
- 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.
Key exclusion criteria (9 listed)
- Pregnancy
- Presence of established connective tissue disease
- Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
- Use of supplemental oxygen at rest
- Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease assessmentAlso: Pulmonary function test (PFT), High Resolution Computed Tomography (HRCT) of the Chest, 6-minute walking distance (6MWD), blood for genomics, functional genomics and protein biomarker analysisA comprehensive evaluation of the disease's extension, its impact on function, quality of life, and the search for phenotype/endotypes will be performed. The association between endotypes and disease progression will be tested. | Other | Hypersensitivity pneumonitis |
Primary outcome
Variation in Forced Vital Capacity (FVC) as a continuous variable
Time frame: 24 months
4 secondary outcomes
Variation in Computed Tomography Lung Densitometry
Time frame: 24 months
Time to death or lung transplantation
Time frame: 24 months
Acute exacerbation rate
Time frame: 24 months
King´s Brief Interstitial Lung Disease Questionnaire (K-BILD)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samara Pinheiro (Project Manager) contact
Leticia Kawano Dourado, MD principal investigator
HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
Prof. Alexandra Latini, PhD study chair
Federal University of Santa Catarina
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity Pneumonitis, run by Hospital do Coracao at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil, Argentina, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leticia Kawano-Dourado (PI), MD (+551130536611, ldourado@hcor.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in Forced Vital Capacity (FVC) as a continuous variable (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.