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

Sponsor

Hopital Foch (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826522

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

6.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Disease	Other: observationnal

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Preliminary Monocentric Study for the Validation of the Circuit of Examinations and Analyzes of Samples in Perspective of Large-scale Application for Better Classification of Airway Diseases

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
asthmatics and asthmatics previously	Other: observationnal cohort of blood collection and severals exams
COPD (chronic obstructive pulmonary disease) patients	Other: observationnal cohort of blood collection and severals exams
cystic fibrosis patients	Other: observationnal cohort of blood collection and severals exams
patients with immunodeficiency with bronchial obstruction	Other: observationnal cohort of blood collection and severals exams
lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD)	Other: observationnal cohort of blood collection and severals exams

Outcome Measures

Primary Outcome Measures

To validate the circuit of examinations and sample analysis within the Foch hospital to show that this study is feasible on a large scale (600 patients) [one year]
ensure that all patients included have undergone the examinations indicated in the protocol

Secondary Outcome Measures

To show that the small number of patients (50) partly achieves the objectives of the next "ROAD 2028" multicentric trial (600 patients) [one year]
ensure that all patients included have undergone the examinations indicated in the protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hopital Foch
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Foch

ClinicalTrials.gov Identifier:

NCT05826522

Other Study ID Numbers:

2022-A01154-39

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 24, 2023