Study for the Validation of the Circuit of Examinations and Analyzes for Better Classification of Airway Diseases (BABY-ROAD)

Hopital Foch

Status

Not yet enrolling

Conditions

Airway Disease

Treatments

Other: observationnal

Study type

Observational

Funder types

Other

Identifiers

NCT05826522

2022-A01154-39

Details and patient eligibility

About

ADs (airway diseases) are a group of progressive diseases that lead to a decline of lung function, accelerated by recurrent exacerbations, which can lead to death. ADs include a number of different conditions including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), bronchiectasis and bronchiolitis frequently related to immune difciency or hematopoietic stem cell transplantations (HSCT), and obstructive chronic lung allograft dysfunction (O-CLAD). The financial burden of ADs is monumental. It is imperative to prevent exacerbations and decline in lung function to reduce ADs mortality and morbidity. The vast amount of knowledge accumulated over the last several years in both biotechnology and digital intelligence, has afforded the evidence of the presence of various treatable traits spread among ADs, that imposes to reassess ADs. BABY-ROAD study proposes to take advantage of these advances to test the feasibility of sampling and exploring ADs patients with multisource data. Baby-ROAD study will be preliminary to the ROAD study that will propose to reclassify ADs into new clusters pertinent for preventive, personalized and participative care.

Full description

Study population: Patients who are part of the group of ADs. This group of progressive diseases lead to a decline of lung function which is accelerated by recurrent exacerbations, which can in turn lead to death. The study population will include severe asthmatics and asthmatics previously hospitalized at least once in 2016 - 2019, COPD (chronic obstructive pulmonary disease) patients previously hospitalized at least once in 2016 - 2019, cystic fibrosis patients, patients with immunodeficiency with bronchial obstruction, lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD) and hematopoietic stem cell transplant recipients with bronchial obstruction.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults
Severe asthmatics + asthmatics previously hospitalized at least once in 2016 - 2019
COPD patients previously hospitalized at least once in 2016 - 2019 Cystic fibrosis patients, patients with immunodeficiency, without bone marrow transplantation, and with AD determined upon bronchial obstruction (FEV1/FVC < 70%).
Lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD)
Hematopoietic stem cell transplant recipients with AD determined upon bronchial obstruction.
Patients already followed-up in pulmonology clinic at the Foch Hospital
Patients understanding the French language
Patients having signed an informed consent form prior to any study specific procedure
Patients being covered by a national health insurance

Exclusion criteria

COPD patients previously hospitalized but before 2016
Immunocompromised patients, having had a bone marrow transplant and suffering from AD determined by bronchial obstruction (FEV1/FVC > 70%).
Patients weighing less than 50 kg
Pregnant women
Patients who are not followed in pulmonology consultation at Foch Hospital
Patients don't understanding the French language
Don't being covered by a national health insurance
Being deprived of liberty or under guardianship