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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	ensure that all patients included have undergone the examinations indicated in the protocol	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2023
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A01154-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No