Airway DiseaseBABY-ROADNCT05826522
Study for the Validation of the Circuit of Examinations and Analyzes for Better Classification of Airway Diseases
An observational study of Airway Disease, run by Hopital Foch.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Disease
- What is being tested?
- observationnal
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 1 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Airway Disease
- Being tested
- observationnal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationnalOther
cohort of blood collection and severals exams
| Study group | Role | What they receive |
|---|---|---|
| asthmatics and asthmatics previously | Not described Receives: Other: observationnal | |
| COPD (chronic obstructive pulmonary disease) patients | Not described Receives: Other: observationnal | |
| cystic fibrosis patients | Not described Receives: Other: observationnal | |
| patients with immunodeficiency with bronchial obstruction | Not described Receives: Other: observationnal | |
| lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD) | Not described Receives: Other: observationnal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 May 2023 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826522
- Sponsor's protocol ID
- 2022-A01154-39
- Acronym
- BABY-ROAD
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05826522
- Acronym / sponsor ID
- BABY-ROAD / 2022-A01154-39
- Conditions
- Airway Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 24 Apr 2023 (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.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| asthmatics and asthmatics previously | – | Other: observationnal |
| COPD (chronic obstructive pulmonary disease) patients | – | Other: observationnal |
| cystic fibrosis patients | – | Other: observationnal |
| patients with immunodeficiency with bronchial obstruction | – | Other: observationnal |
| lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD) | – | Other: observationnal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| observationnalcohort of blood collection and severals exams | Other | COPD (chronic obstructive pulmonary disease) patients, asthmatics and asthmatics previously, cystic fibrosis patients, lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD), patients with immunodeficiency with bronchial obstruction |
Primary outcome
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)
Time frame: one year
ensure that all patients included have undergone the examinations indicated in the protocol
1 secondary outcome
To show that the small number of patients (50) partly achieves the objectives of the next "ROAD 2028" multicentric trial (600 patients)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Disease, run by Hopital Foch.
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 9 inclusion and 8 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: one year). 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 24 Apr 2023.