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Research on Severe Asthma (RAMSES)

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ClinicalTrials.gov Identifier: NCT04077528
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research on Severe Asthma
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Number of patients receiving asthma treatment [ Time Frame: Previous treatment, collected at baseline ]
    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.

  2. Dose of severe asthma treatments [ Time Frame: At baseline ]
    Severe asthma medication (high dose inhaled corticosteroids / B2LDA, Anti IgE antibody, Anti IL5 antibody, daily oral steroids…)

  3. Duration of asthma treatments [ Time Frame: Previous treatment, collected at baseline ]
    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.

  4. Other medications [ Time Frame: At baseline ]
    Number of patients receiving antidiabetics, Number of patients receiving antidepressants, Number of patients receiving anti-osteoporotic drugs, Number of patients receiving cardiovascular drugs.

  5. Asthma-related comorbidities [ Time Frame: At baseline ]
    Prevalence of asthma related comorbidities such as chronic rhinosinusitis, nasal polyps, gastroesophageal reflux, obesity, obstructive sleep apnea respiratory infections, …

  6. Non-respiratory comorbidities [ Time Frame: At baseline ]
    Prevalence of non-respiratory comorbidities such as osteoporosis, diabetes , cardiovascular diseases...

  7. Asthma control test (ACT) [ Time Frame: 12 previous months, collected at baseline ]
    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.

  8. Asthma exacerbations [ Time Frame: 12 previous months, collected at baseline ]
    Number of systemic corticosteroids (SC) courses

  9. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 12 previous months, collected at baseline ]
    Mean FEV1, expressed in ml.

  10. Number of patients with at least 1 sick leaves due to asthma [ Time Frame: 12 previous months, collected at baseline ]
    Patient-reported sick leaves.

  11. Number of sick leaves due to asthma [ Time Frame: 12 previous months, collected at baseline ]
    Patient-reported sick leaves.

  12. Number of patients with long term disease status for asthma [ Time Frame: At baseline ]
  13. Intensive care unit hospitalization due to asthma exacerbation [ Time Frame: During life, collected at baseline ]
    At least one intensive care unit hospitalization for asthma


Secondary Outcome Measures :
  1. Number of unscheduled healthcare visits or hospitalization [ Time Frame: At 6 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  2. Number of patients with unscheduled healthcare visits or hospitalization [ Time Frame: At 6 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  3. Number of unscheduled healthcare visits or hospitalization [ Time Frame: At 12 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  4. Number of patients with unscheduled healthcare visits or hospitalization [ Time Frame: At 12 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  5. Number of unscheduled healthcare visits or hospitalization [ Time Frame: At 24 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  6. Number of patients with unscheduled healthcare visits or hospitalization [ Time Frame: At 24 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  7. Number of unscheduled healthcare visits or hospitalization [ Time Frame: At 36 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  8. Number of patients with unscheduled healthcare visits or hospitalization [ Time Frame: At 36 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  9. Number of unscheduled healthcare visits or hospitalization [ Time Frame: At 60 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  10. Number of patients with unscheduled healthcare visits or hospitalization [ Time Frame: At 60 months ]
    Inpatient hospitalizations due to asthma including intensive care unit, inpatient hospitalization for other reasons, emergency department visits and unscheduled ambulatory visits

  11. Daily dose of corticosteroids [ Time Frame: At 6 months ]
    Inhaled corticosteroids, oral corticosteroids (SC) in long term users

  12. Daily dose of corticosteroids [ Time Frame: At 12 months ]
    Inhaled corticosteroids, oral corticosteroids (SC) in long term users

  13. Daily dose of corticosteroids [ Time Frame: At 24 months ]
    Inhaled corticosteroids, oral corticosteroids (SC) in long term users

  14. Daily dose of corticosteroids [ Time Frame: At 36 months ]
    Inhaled corticosteroids, oral corticosteroids (SC) in long term users

  15. Daily dose of corticosteroids [ Time Frame: At 60 months ]
    Inhaled corticosteroids, oral corticosteroids (SC) in long term users

  16. Number of patients with at least 1 other asthma medication [ Time Frame: At 6 months ]
    Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.

  17. Number of patients with at least 1 other asthma medication [ Time Frame: At 12 months ]
    Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.

  18. Number of patients with at least 1 other asthma medication [ Time Frame: At 24 months ]
    Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.

  19. Number of patients with at least 1 other asthma medication [ Time Frame: At 36 months ]
    Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.

  20. Number of patients with at least 1 other asthma medication [ Time Frame: At 60 months ]
    Long acting beta 2 agonists, long acting anticholinergics, montelukast, macrolides, Anti IgE monoclonal antibodies, theophylline.

  21. Asthma exacerbations [ Time Frame: 6 months ]
    Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users

  22. Asthma exacerbations [ Time Frame: At 12 months ]
    Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users

  23. Asthma exacerbations [ Time Frame: At 24 months ]
    Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users

  24. Asthma exacerbations [ Time Frame: At 36 months ]
    Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users

  25. Asthma exacerbations [ Time Frame: At 60 months ]
    Systemic corticosteroids (SC) use or doubling the usual dose or at least 48 hours in SC long term users

  26. Number of patients reporting suboptimal treatment adherence [ Time Frame: Through study completion, an average of 5 years ]
    Patient-reported adherence to asthma treatment. Suboptimal treatment is defined as less treatment received than expected.

  27. Drug survival rate [ Time Frame: At 6 month ]
    Proportion of patients still exposed to treatment

  28. Drug survival rate [ Time Frame: At 12 months ]
    Proportion of patients still exposed to treatment;

  29. Time to drug discontinuation [ Time Frame: Reported at 6 month ]
    Median time between the start of treatment and its definitive cessation

  30. Time to drug discontinuation [ Time Frame: Reported at 12 month ]
    Median time between the start of treatment and its definitive cessation.

  31. Asthma control test (ACT) [ Time Frame: At 6 months ]
    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).

  32. Asthma control test (ACT) [ Time Frame: At 12 months ]
    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).

  33. Asthma control test (ACT) [ Time Frame: At 24 months ]
    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).

  34. Asthma control test (ACT) [ Time Frame: At 36 months ]
    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).

  35. Asthma control test (ACT) [ Time Frame: At 60 months ]
    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).

  36. Number of patients with at least 1 sick leaves due to asthma [ Time Frame: At 6 months ]
    Patient-reported sick leaves.

  37. Number of sick leaves due to asthma [ Time Frame: At 6 months ]
    Patient-reported sick leaves.

  38. Number of patients with at least 1 sick leaves due to asthma [ Time Frame: At 12 months ]
    Patient-reported sick leaves.

  39. Number of sick leaves due to asthma [ Time Frame: At 12 months ]
    Patient-reported sick leaves.

  40. Number of patients with at least 1 sick leaves due to asthma [ Time Frame: At 24 months ]
    Patient-reported sick leaves.

  41. Number of sick leaves due to asthma [ Time Frame: At 24 months ]
    Patient-reported sick leaves.

  42. Number of patients with at least 1 sick leaves due to asthma [ Time Frame: At 36 months ]
    Patient-reported sick leaves.

  43. Number of sick leaves due to asthma [ Time Frame: At 36 months ]
    Patient-reported sick leaves.

  44. Number of patients with at least 1 sick leaves due to asthma [ Time Frame: At 60 months ]
    Patient-reported sick leaves.

  45. Number of sick leaves due to asthma [ Time Frame: At 60 months ]
    Patient-reported sick leaves.

  46. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: At 6 months ]
    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.

  47. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: At 12 months ]
    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.

  48. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: At 24 months ]
    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.

  49. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: At 36 months ]
    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.

  50. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: At 60 months ]
    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.

  51. Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit [ Time Frame: At 6 months ]
    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.

  52. Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit [ Time Frame: At 12 months ]
    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.

  53. Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit [ Time Frame: At 24 months ]
    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.

  54. Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit [ Time Frame: At 36 months ]
    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.

  55. Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit [ Time Frame: At 60 months ]
    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.

  56. EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment [ Time Frame: At 6 months ]

    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).


  57. EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment [ Time Frame: At 12 months ]

    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).


  58. EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment [ Time Frame: At 24 months ]

    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).


  59. EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment [ Time Frame: At 36 months ]

    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).


  60. EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment [ Time Frame: At 60 months ]

    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).


  61. Hospital Anxiety and Depression scale [ Time Frame: At 6 months ]
    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.

  62. Hospital Anxiety and Depression scale [ Time Frame: At 12 months ]
    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.

  63. Hospital Anxiety and Depression scale [ Time Frame: At 24 months ]
    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.

  64. Hospital Anxiety and Depression scale [ Time Frame: At 36 months ]
    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.

  65. Hospital Anxiety and Depression scale [ Time Frame: At 60 months ]
    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.

  66. Long term adverse Events associated with corticosteroid therapy. [ Time Frame: 60 months ]
    Frequency of relevant medical events such as osteoporosis, diabetes, cardiovascular disease.

  67. Asthma-related comorbidities [ Time Frame: At 6 months ]
    Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …

  68. Asthma-related comorbidities [ Time Frame: At 12 months ]
    Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …

  69. Asthma-related comorbidities [ Time Frame: At 24 months ]
    Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …

  70. Asthma-related comorbidities [ Time Frame: At 36 months ]
    Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …

  71. Asthma-related comorbidities [ Time Frame: At 60 months ]
    Prevalence of comorbidities such as rhinosinusitis, obesity, gastroesophageal reflux, sleep obstructive apnea syndrome, …

  72. Death and cause of death [ Time Frame: At 6 months ]
  73. Death and cause of death [ Time Frame: At 12 months ]
  74. Death and cause of death [ Time Frame: At 24 months ]
  75. Death and cause of death [ Time Frame: At 36 months ]
  76. Death and cause of death [ Time Frame: At 60 months ]
  77. Post-procedural adverse Events associated with bronchial thermoplasty [ Time Frame: Up to 24 hours following the procedure ]
    Frequency of post-procedure medical events such as hemoptysis, respiratory symptoms, asthma, prolonged hospitalization

  78. Post-procedural adverse Events associated with bronchial thermoplasty [ Time Frame: From 24 hours to 1 month following the procedure ]
    Frequency of post-procedure medical events such as hemoptysis, respiratory symptoms, asthma, prolonged hospitalization.

  79. Long term adverse events associated with bronchial thermoplasty [ Time Frame: 60 months ]
    Frequency of long term medical events such as bronchial stenosis.

  80. Events of special interest [ Time Frame: From treatment initiation to 3 months following treatment initiation ]
    Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis.

  81. Events of special interest [ Time Frame: From 3 months to 12 months following treatment initiation ]
    Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis.

  82. Events of special interest [ Time Frame: From 3 to 5 years following treatment initiation ]
    Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis.

  83. Blood eosinophil count [ Time Frame: At baseline ]
  84. Total immunoglobulin E (IgE) [ Time Frame: At baseline ]
  85. Chest computed tomography scan [ Time Frame: At baseline ]
    Dates and description of major findings.

  86. Forced Vital Capacity (FVC) [ Time Frame: At baseline ]
  87. Forced Vital Capacity (FVC) [ Time Frame: At 6 months ]
  88. Forced Vital Capacity (FVC) [ Time Frame: At 12 months ]
  89. Forced Vital Capacity (FVC) [ Time Frame: At 24 months ]
  90. Forced Vital Capacity (FVC) [ Time Frame: At 36 months ]
  91. Forced Vital Capacity (FVC) [ Time Frame: At 60 months ]
  92. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: At 6 months ]
  93. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: At 12 months ]
  94. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: At 24 months ]
  95. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: At 36 months ]
  96. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: At 60 months ]
  97. FEV1/FVC ratio [ Time Frame: At baseline ]
  98. FEV1/FVC ratio [ Time Frame: At 6 months ]
  99. FEV1/FVC ratio [ Time Frame: At 12 months ]
  100. FEV1/FVC ratio [ Time Frame: At 24 months ]
  101. FEV1/FVC ratio [ Time Frame: At 36 months ]
  102. FEV1/FVC ratio [ Time Frame: At 60 months ]
  103. RV/TLC ratio [ Time Frame: At baseline ]
  104. RV/TLC ratio [ Time Frame: At 6 months ]
  105. RV/TLC ratio [ Time Frame: At 12 months ]
  106. RV/TLC ratio [ Time Frame: At 24 months ]
  107. RV/TLC ratio [ Time Frame: At 36 months ]
  108. RV/TLC ratio [ Time Frame: At 60 months ]
  109. Fractional exhaled nitric oxide (FENO) [ Time Frame: At baseline ]
  110. Costs of severe asthma management [ Time Frame: Through study completion, an average of 5 years ]
    Total amount of money, expressed in euros, reimbursed by Social Security ( for treatments, medical visits, radiological or laboratory examinations).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult severe asthma patients treated in France
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077528


Contacts
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Contact: Camille TAILLE, MD,PHD 01 40 25 68 63 camille.taille@aphp.fr
Contact: Candice ESTELLAT, Dr 01 42 16 75 72 candice.estellat@aphp.fr

Locations
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France
CHU Bichat Recruiting
Paris, France, 75877
Contact: Yannick VACHER    01.44.84.17.30    yannick.vacher@aphp.fr   
Contact: Sarra POCHON    01 42 16 75 74    sarra.pochon@aphp.fr   
Principal Investigator: Camille TAILLE, MD,PHD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Camille TAILLE, MD,PHD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04077528    
Other Study ID Numbers: NI18033J
2018-A03282-53 ( Registry Identifier: Numeber IDRCB )
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Severe asthma
Adult
Respiratory disease
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases