Research on Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Asthma-related comorbidities
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient does not accept the recording of his data in the cohort
- •Patient not benefiting from health insurance coverage
- •Patient under curatorship or tutorship
结局指标
主要结局
Asthma-related comorbidities
时间窗: At baseline
Prevalence of asthma related comorbidities such as chronic rhinosinusitis, nasal polyps, gastroesophageal reflux, obesity, obstructive sleep apnea respiratory infections, ...
Forced Expiratory Volume in 1 second (FEV1)
时间窗: 12 previous months, collected at baseline
Mean FEV1, expressed in ml.
Number of patients receiving asthma treatment
时间窗: 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.
Dose of severe asthma treatments
时间窗: At baseline
Severe asthma medication (high dose inhaled corticosteroids / B2LDA, Anti IgE antibody, Anti IL5 antibody, daily oral steroids...)
Duration of asthma treatments
时间窗: 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.
Other medications
时间窗: 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.
Non-respiratory comorbidities
时间窗: At baseline
Prevalence of non-respiratory comorbidities such as osteoporosis, diabetes , cardiovascular diseases...
Asthma exacerbations
时间窗: 12 previous months, collected at baseline
Number of systemic corticosteroids (SC) courses
Asthma control test (ACT)
时间窗: 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.
Number of patients with at least 1 sick leaves due to asthma
时间窗: 12 previous months, collected at baseline
Patient-reported sick leaves.
Number of sick leaves due to asthma
时间窗: 12 previous months, collected at baseline
Patient-reported sick leaves.
Number of patients with long term disease status for asthma
时间窗: At baseline
Intensive care unit hospitalization due to asthma exacerbation
时间窗: During life, collected at baseline
At least one intensive care unit hospitalization for asthma
次要结局
- Number of unscheduled healthcare visits or hospitalization(At 60 months)
- Number of patients with at least 1 other asthma medication(At 60 months)
- Asthma exacerbations(At 60 months)
- Drug survival rate(At 12 months)
- Number of patients with at least 1 sick leaves due to asthma(At 60 months)
- Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit(At 60 months)
- Post-procedural adverse Events associated with bronchial thermoplasty(From 24 hours to 1 month following the procedure)
- Long term adverse events associated with bronchial thermoplasty(60 months)
- Total immunoglobulin E (IgE)(At baseline)
- Forced Expiratory Volume in 1 second (FEV1)(At 60 months)
- Number of patients with unscheduled healthcare visits or hospitalization(At 60 months)
- Daily dose of corticosteroids(At 60 months)
- Number of sick leaves due to asthma(At 60 months)
- St. George's Respiratory Questionnaire (SGRQ)(At 60 months)
- EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment(At 60 months)
- Hospital Anxiety and Depression scale(At 60 months)
- Death and cause of death(At 60 months)
- RV/TLC ratio(At 60 months)
- Number of patients reporting suboptimal treatment adherence(Through study completion, an average of 5 years)
- Time to drug discontinuation(Reported at 12 month)
- Asthma control test (ACT)(At 60 months)
- Long term adverse Events associated with corticosteroid therapy.(60 months)
- Blood eosinophil count(At baseline)
- FEV1/FVC ratio(At 60 months)
- Asthma-related comorbidities(At 60 months)
- Events of special interest(From 3 to 5 years following treatment initiation)
- Forced Vital Capacity (FVC)(At 60 months)
- Chest computed tomography scan(At baseline)
- Costs of severe asthma management(Through study completion, an average of 5 years)
- Fractional exhaled nitric oxide (FENO)(At baseline)