Research on Severe Asthma (RAMSES)

The French Society for Respiratory diseases (SPLF), through its Asthma and Allergy working group (G2A), wishes to set up a national cohort of severe asthma patients to describe this population and the use of step 4 and 5 treatment. This study also meets the demand for post - registration studies required by the Health Authorities for biotherapies and bronchial thermoplasty.

Other European or international cohorts of asthmatic patients exist and RAMSES could contribute to data sharing initiatives.

Study Overview

• Status: Recruiting
• Conditions: Adult Severe Asthma Patients Treated in France

Detailed Description

Severe asthma is defined by poorly controlled disease despite treatment with high doses of inhaled corticosteroids, in combination with at least a long acting beta agonist, after optimal management for at least 6 months by an asthma specialist. The diagnosis of severe asthma can only be made after a rigorous evaluation of 6 to 12 months, including the review of diagnosis and treatment, by a pulmonologist, to distinguish difficult asthma from severe asthma.

Severe asthma accounts for 3.5% to 5% of all asthma patients, a population estimated at 150 000 patients in France. This disease is responsible for significant health costs related to asthma treatments, comorbidities, hospitalizations and sick days. The management of severe asthma is complex, multidisciplinary and includes drug treatment, but also the management of side effects of treatment, including oral corticosteroid therapy, and comorbidities of asthma.

Until 2018, omalizumab,systemic continuous oral corticosteroid therapy or inclusion in a therapeutic trial were the ony possibilities offered to severe asthmatic patients beyond the usually recommended and optimized management. In 2018, mepolizumab and reslizumab have been marketed in France, then benralizumab in 2019. They will probably be followed by dupilumab and bronchial thermoplasty. New initiatives to change the history of the disease are also proposed such as specific immunotherapy or long-term use of macrolides. Respiratory rehabilitation is also part of the treatments to be evaluated in some groups of patients.

The description of the use of these treatments, as well as the evaluation of their effectiveness and tolerance in real life conditions is essential. Indeed, their use outside clinical trials raises a number of issues such as the optimal duration of treatment, the maintenance of efficacy over extended periods, the risk and the time to relapse when the treatment is stopped, the possibility to switch from one biotherapy to another in case of insufficient clinical response or to associate them which may prove to be an effective strategy in patients eligible for two biotherapies (allergic and eosinophilic patients).

The cost of these treatments is high. The pharmaco-economic evaluation of severe asthma and its management is another important element. For example, no economic evaluation of the use of omalizumab is currently available in France.

Lastly, the organization of a care network dedicated to severe asthma is being launched in France (severe asthma centers ), on the model of European countries, in order to improve the diagnosis and management of these patients and to reduce the burden of comorbidities of asthma and steroids side effects.It is therefore essential to set up a clinical research structure that will make it possible to obtain clinical data on this population of severe asthma patients and to evaluate all medical practices in real life conditions.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Camille TAILLE, MD,PHD; Phone Number: 01 40 25 68 63; Email: camille.taille@aphp.fr
• Study Contact Backup: Name: Candice ESTELLAT, Dr; Phone Number: 01 42 16 75 72; Email: candice.estellat@aphp.fr

Study Locations

• France
  • Paris, France, 75877
    • Recruiting
    • CHU Bichat
    • Contact: Sarra POCHON; Phone Number: 01 42 16 75 74; Email: sarra.pochon@aphp.fr
    • Contact: Yannick VACHER; Phone Number: 01.44.84.17.30; Email: yannick.vacher@aphp.fr
    • Principal Investigator: Camille TAILLE, MD,PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult severe asthma patients treated in France

Description

Inclusion Criteria:

- Patient with severe asthma : Meeting the definition of ATS-ERS: which requires a combination of high dose CSI and B2LDA.

Or receiving level 5 support (initiating treatment or already treated) :

• Long-term oral corticosteroids (> 6 months in the year prior to inclusion)
• And / or monoclonal antibody
• And / or bronchial thermoplasty

• And / or other complex costs corresponding to the level 5 treatments

  • Consultant or hospitalized in one of the centers participating in RAMSES study

Exclusion Criteria:

• Patient does not accept the recording of his data in the cohort
• Patient not benefiting from health insurance coverage
• Patient under curatorship or tutorship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients receiving asthma treatment	Severe asthma medication (high dose inhaled corticosteroids / B2LDA, Anti IgE antibody, Anti IL5 antibody, daily oral steroids…); Other asthma medications (long acting anticholinergics, montelukast, theophylline, inhaled corticoids); bronchial thermoplasty.	Previous treatment, collected at baseline
Dose of severe asthma treatments	Severe asthma medication (high dose inhaled corticosteroids / B2LDA, Anti IgE antibody, Anti IL5 antibody, daily oral steroids…)	At baseline
Duration of asthma treatments	Severe asthma medication (high dose inhaled corticosteroids / B2LDA, Anti IgE antibody, Anti IL5 antibody, daily oral steroids…); Other asthma medications (long acting anticholinergics, montelukast, theophylline, inhaled corticoids); bronchial thermoplasty.	Previous treatment, collected at baseline
Other medications	Number of patients receiving antidiabetics, Number of patients receiving antidepressants, Number of patients receiving anti-osteoporotic drugs, Number of patients receiving cardiovascular drugs.	At baseline
Asthma-related comorbidities	Prevalence of asthma related comorbidities such as chronic rhinosinusitis, nasal polyps, gastroesophageal reflux, obesity, obstructive sleep apnea respiratory infections, …	At baseline
Non-respiratory comorbidities	Prevalence of non-respiratory comorbidities such as osteoporosis, diabetes , cardiovascular diseases...	At baseline
Asthma control test (ACT)	Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 items, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). Asthma is controlled when the total score is >20.	12 previous months, collected at baseline
Asthma exacerbations	Number of systemic corticosteroids (SC) courses	12 previous months, collected at baseline
Forced Expiratory Volume in 1 second (FEV1)	Mean FEV1, expressed in ml.	12 previous months, collected at baseline
Number of patients with at least 1 sick leaves due to asthma	Patient-reported sick leaves.	12 previous months, collected at baseline
Number of sick leaves due to asthma	Patient-reported sick leaves.	12 previous months, collected at baseline
Number of patients with long term disease status for asthma		At baseline
Intensive care unit hospitalization due to asthma exacerbation	At least one intensive care unit hospitalization for asthma	During life, collected at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 6 months
Number of patients with unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 6 months
Number of unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 12 months
Number of patients with unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 12 months
Number of unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 24 months
Number of patients with unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 24 months
Number of unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 36 months
Number of patients with unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 36 months
Number of unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 60 months
Number of patients with unscheduled healthcare visits or hospitalization	Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits	At 60 months
Daily dose of corticosteroids	Inhaled corticosteroids, oral corticosteroids (SC) in long term users	At 6 months
Daily dose of corticosteroids	Inhaled corticosteroids, oral corticosteroids (SC) in long term users	At 12 months
Daily dose of corticosteroids	Inhaled corticosteroids, oral corticosteroids (SC) in long term users	At 24 months
Daily dose of corticosteroids	Inhaled corticosteroids, oral corticosteroids (SC) in long term users	At 36 months
Daily dose of corticosteroids	Inhaled corticosteroids, oral corticosteroids (SC) in long term users	At 60 months
Number of patients with at least 1 other asthma medication	Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.	At 6 months
Number of patients with at least 1 other asthma medication	Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.	At 12 months
Number of patients with at least 1 other asthma medication	Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.	At 24 months
Number of patients with at least 1 other asthma medication	Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.	At 36 months
Number of patients with at least 1 other asthma medication	Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.	At 60 months
Asthma exacerbations	Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users	6 months
Asthma exacerbations	Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users	At 12 months
Asthma exacerbations	Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users	At 24 months
Asthma exacerbations	Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users	At 36 months
Asthma exacerbations	Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users	At 60 months
Number of patients reporting suboptimal treatment adherence	Patient-reported adherence to asthma treatment. Suboptimal treatment is defined as less treatment received than expected.	Through study completion, an average of 5 years
Drug survival rate	Proportion of patients still exposed to treatment	At 6 month
Drug survival rate	Proportion of patients still exposed to treatment;	At 12 months
Time to drug discontinuation	Median time between the start of treatment and its definitive cessation	Reported at 6 month
Time to drug discontinuation	Median time between the start of treatment and its definitive cessation.	Reported at 12 month
Asthma control test (ACT)	Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 item, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled).	At 6 months
Asthma control test (ACT)	Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 item, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled).	At 12 months
Asthma control test (ACT)	Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 item, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled).	At 24 months
Asthma control test (ACT)	Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 item, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled).	At 36 months
Asthma control test (ACT)	Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 item, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled).	At 60 months
Number of patients with at least 1 sick leaves due to asthma	Patient-reported sick leaves.	At 6 months
Number of sick leaves due to asthma	Patient-reported sick leaves.	At 6 months
Number of patients with at least 1 sick leaves due to asthma	Patient-reported sick leaves.	At 12 months
Number of sick leaves due to asthma	Patient-reported sick leaves.	At 12 months
Number of patients with at least 1 sick leaves due to asthma	Patient-reported sick leaves.	At 24 months
Number of sick leaves due to asthma	Patient-reported sick leaves.	At 24 months
Number of patients with at least 1 sick leaves due to asthma	Patient-reported sick leaves.	At 36 months
Number of sick leaves due to asthma	Patient-reported sick leaves.	At 36 months
Number of patients with at least 1 sick leaves due to asthma	Patient-reported sick leaves.	At 60 months
Number of sick leaves due to asthma	Patient-reported sick leaves.	At 60 months
St. George's Respiratory Questionnaire (SGRQ)	The St. George's Respiratory Questionnaire (SGRQ) is a self-reporting questionnaire validated for evaluating quality of life in asthma. The total score is expressed as a percentage, from 0%, no impairment of life quality, to 100%, maximal impairment.	At 6 months
St. George's Respiratory Questionnaire (SGRQ)	The St. George's Respiratory Questionnaire (SGRQ) is a self-reporting questionnaire validated for evaluating quality of life in asthma. The total score is expressed as a percentage, from 0%, no impairment of life quality, to 100%, maximal impairment.	At 12 months
St. George's Respiratory Questionnaire (SGRQ)	The St. George's Respiratory Questionnaire (SGRQ) is a self-reporting questionnaire validated for evaluating quality of life in asthma. The total score is expressed as a percentage, from 0%, no impairment of life quality, to 100%, maximal impairment.	At 24 months
St. George's Respiratory Questionnaire (SGRQ)	The St. George's Respiratory Questionnaire (SGRQ) is a self-reporting questionnaire validated for evaluating quality of life in asthma. The total score is expressed as a percentage, from 0%, no impairment of life quality, to 100%, maximal impairment.	At 36 months
St. George's Respiratory Questionnaire (SGRQ)	The St. George's Respiratory Questionnaire (SGRQ) is a self-reporting questionnaire validated for evaluating quality of life in asthma. The total score is expressed as a percentage, from 0%, no impairment of life quality, to 100%, maximal impairment.	At 60 months
Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit	The AQLQ is a 32-item disease-specific questionnaire that has been designed to measure the functional impairments that are most troublesome to adults with asthma. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions.	At 6 months
Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit	The AQLQ is a 32-item disease-specific questionnaire that has been designed to measure the functional impairments that are most troublesome to adults with asthma. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions.	At 12 months
Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit	The AQLQ is a 32-item disease-specific questionnaire that has been designed to measure the functional impairments that are most troublesome to adults with asthma. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions.	At 24 months
Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit	The AQLQ is a 32-item disease-specific questionnaire that has been designed to measure the functional impairments that are most troublesome to adults with asthma. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions.	At 36 months
Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit	The AQLQ is a 32-item disease-specific questionnaire that has been designed to measure the functional impairments that are most troublesome to adults with asthma. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions.	At 60 months
EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". Pain/discomfort dimension asks how much pain or discomfort the person has, and anxiety/depression dimension asks how anxious or depressed the person is. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).	At 6 months
EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". Pain/discomfort dimension asks how much pain or discomfort the person has, and anxiety/depression dimension asks how anxious or depressed the person is. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).	At 12 months
EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". Pain/discomfort dimension asks how much pain or discomfort the person has, and anxiety/depression dimension asks how anxious or depressed the person is. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).	At 24 months
EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". Pain/discomfort dimension asks how much pain or discomfort the person has, and anxiety/depression dimension asks how anxious or depressed the person is. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).	At 36 months
EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". Pain/discomfort dimension asks how much pain or discomfort the person has, and anxiety/depression dimension asks how anxious or depressed the person is. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).	At 60 months
Hospital Anxiety and Depression scale	The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	At 6 months
Hospital Anxiety and Depression scale	The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	At 12 months
Hospital Anxiety and Depression scale	The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	At 24 months
Hospital Anxiety and Depression scale	The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	At 36 months
Hospital Anxiety and Depression scale	The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	At 60 months
Long term adverse Events associated with corticosteroid therapy.	Frequency of relevant medical events such as osteoporosis, diabetes, cardiovascular disease.	60 months
Asthma-related comorbidities	Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …	At 6 months
Asthma-related comorbidities	Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …	At 12 months
Asthma-related comorbidities	Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …	At 24 months
Asthma-related comorbidities	Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …	At 36 months
Asthma-related comorbidities	Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …	At 60 months
Death and cause of death		At 6 months
Death and cause of death		At 12 months
Death and cause of death		At 24 months
Death and cause of death		At 36 months
Death and cause of death		At 60 months
Post-procedural adverse Events associated with bronchial thermoplasty	Frequency of post-procedure medical events such as hemoptysis, respiratory symptoms, asthma, prolonged hospitalization	Up to 24 hours following the procedure
Post-procedural adverse Events associated with bronchial thermoplasty	Frequency of post-procedure medical events such as hemoptysis, respiratory symptoms, asthma, prolonged hospitalization.	From 24 hours to 1 month following the procedure
Long term adverse events associated with bronchial thermoplasty	Frequency of long term medical events such as bronchial stenosis.	60 months
Events of special interest	Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis.	From treatment initiation to 3 months following treatment initiation
Events of special interest	Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis.	From 3 months to 12 months following treatment initiation
Events of special interest	Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis.	From 3 to 5 years following treatment initiation
Blood eosinophil count		At baseline
Total immunoglobulin E (IgE)		At baseline
Chest computed tomography scan	Dates and description of major findings.	At baseline
Forced Vital Capacity (FVC)		At baseline
Forced Vital Capacity (FVC)		At 6 months
Forced Vital Capacity (FVC)		At 12 months
Forced Vital Capacity (FVC)		At 24 months
Forced Vital Capacity (FVC)		At 36 months
Forced Vital Capacity (FVC)		At 60 months
Forced Expiratory Volume in 1 second (FEV1)		At 6 months
Forced Expiratory Volume in 1 second (FEV1)		At 12 months
Forced Expiratory Volume in 1 second (FEV1)		At 24 months
Forced Expiratory Volume in 1 second (FEV1)		At 36 months
Forced Expiratory Volume in 1 second (FEV1)		At 60 months
FEV1/FVC ratio		At baseline
FEV1/FVC ratio		At 6 months
FEV1/FVC ratio		At 12 months
FEV1/FVC ratio		At 24 months
FEV1/FVC ratio		At 36 months
FEV1/FVC ratio		At 60 months
RV/TLC ratio		At baseline
RV/TLC ratio		At 6 months
RV/TLC ratio		At 12 months
RV/TLC ratio		At 24 months
RV/TLC ratio		At 36 months
RV/TLC ratio		At 60 months
Fractional exhaled nitric oxide (FENO)		At baseline
Costs of severe asthma management	Total amount of money, expressed in euros, reimbursed by Social Security ( for treatments, medical visits, radiological or laboratory examinations).	Through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Camille TAILLE, MD,PHD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Adult; Respiratory disease; Severe asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: NI18033J; 2018-A03282-53 (Registry Identifier: Numeber IDRCB)

Drug and device information, study documents

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