Clinical trial NCT04077528: Research on Severe Asthma
Official title: Research on Severe Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Severe Asthma Patients Treated in France
Keywords: Severe asthma
Adult
Respiratory disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult severe asthma patients treated in France

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of patients receiving asthma treatment
timeFrame: Previous treatment, collected at baseline
measure: Dose of severe asthma treatments
timeFrame: At baseline
measure: Duration of asthma treatments
timeFrame: Previous treatment, collected at baseline
measure: Other medications
timeFrame: At baseline
measure: Asthma-related comorbidities
timeFrame: At baseline
measure: Non-respiratory comorbidities
timeFrame: At baseline
measure: Asthma control test (ACT)
timeFrame: 12 previous months, collected at baseline
measure: Asthma exacerbations
timeFrame: 12 previous months, collected at baseline
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 12 previous months, collected at baseline
measure: Number of patients with at least 1 sick leaves due to asthma
timeFrame: 12 previous months, collected at baseline
measure: Number of sick leaves due to asthma
timeFrame: 12 previous months, collected at baseline
measure: Number of patients with long term disease status for asthma
timeFrame: At baseline
measure: Intensive care unit hospitalization due to asthma exacerbation
timeFrame: During life, collected at baseline
Secondary outcomes:
measure: Number of unscheduled healthcare visits or hospitalization
timeFrame: At 6 months
measure: Number of patients with unscheduled healthcare visits or hospitalization
timeFrame: At 6 months
measure: Number of unscheduled healthcare visits or hospitalization
timeFrame: At 12 months
measure: Number of patients with unscheduled healthcare visits or hospitalization
timeFrame: At 12 months
measure: Number of unscheduled healthcare visits or hospitalization
timeFrame: At 24 months
measure: Number of patients with unscheduled healthcare visits or hospitalization
timeFrame: At 24 months
measure: Number of unscheduled healthcare visits or hospitalization
timeFrame: At 36 months
measure: Number of patients with unscheduled healthcare visits or hospitalization
timeFrame: At 36 months
measure: Number of unscheduled healthcare visits or hospitalization
timeFrame: At 60 months
measure: Number of patients with unscheduled healthcare visits or hospitalization
timeFrame: At 60 months
measure: Daily dose of corticosteroids
timeFrame: At 6 months
measure: Daily dose of corticosteroids
timeFrame: At 12 months
measure: Daily dose of corticosteroids
timeFrame: At 24 months
measure: Daily dose of corticosteroids
timeFrame: At 36 months
measure: Daily dose of corticosteroids
timeFrame: At 60 months
measure: Number of patients with at least 1 other asthma medication
timeFrame: At 6 months
measure: Number of patients with at least 1 other asthma medication
timeFrame: At 12 months
measure: Number of patients with at least 1 other asthma medication
timeFrame: At 24 months
measure: Number of patients with at least 1 other asthma medication
timeFrame: At 36 months
measure: Number of patients with at least 1 other asthma medication
timeFrame: At 60 months
measure: Asthma exacerbations
timeFrame: 6 months
measure: Asthma exacerbations
timeFrame: At 12 months
measure: Asthma exacerbations
timeFrame: At 24 months
measure: Asthma exacerbations
timeFrame: At 36 months
measure: Asthma exacerbations
timeFrame: At 60 months
measure: Number of patients reporting suboptimal treatment adherence
timeFrame: Through study completion, an average of 5 years
measure: Drug survival rate
timeFrame: At 6 month
measure: Drug survival rate
timeFrame: At 12 months
measure: Time to drug discontinuation
timeFrame: Reported at 6 month
measure: Time to drug discontinuation
timeFrame: Reported at 12 month
measure: Asthma control test (ACT)
timeFrame: At 6 months
measure: Asthma control test (ACT)
timeFrame: At 12 months
measure: Asthma control test (ACT)
timeFrame: At 24 months
measure: Asthma control test (ACT)
timeFrame: At 36 months
measure: Asthma control test (ACT)
timeFrame: At 60 months
measure: Number of patients with at least 1 sick leaves due to asthma
timeFrame: At 6 months
measure: Number of sick leaves due to asthma
timeFrame: At 6 months
measure: Number of patients with at least 1 sick leaves due to asthma
timeFrame: At 12 months
measure: Number of sick leaves due to asthma
timeFrame: At 12 months
measure: Number of patients with at least 1 sick leaves due to asthma
timeFrame: At 24 months
measure: Number of sick leaves due to asthma
timeFrame: At 24 months
measure: Number of patients with at least 1 sick leaves due to asthma
timeFrame: At 36 months
measure: Number of sick leaves due to asthma
timeFrame: At 36 months
measure: Number of patients with at least 1 sick leaves due to asthma
timeFrame: At 60 months
measure: Number of sick leaves due to asthma
timeFrame: At 60 months
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: At 6 months
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: At 12 months
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: At 24 months
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: At 36 months
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: At 60 months
measure: Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit
timeFrame: At 6 months
measure: Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit
timeFrame: At 12 months
measure: Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit
timeFrame: At 24 months
measure: Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit
timeFrame: At 36 months
measure: Asthma Quality of Life Questionnaire (AQLQ) overall score by Visit
timeFrame: At 60 months
measure: EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment
timeFrame: At 6 months
measure: EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment
timeFrame: At 12 months
measure: EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment
timeFrame: At 24 months
measure: EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment
timeFrame: At 36 months
measure: EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) index score and health state assessment
timeFrame: At 60 months
measure: Hospital Anxiety and Depression scale
timeFrame: At 6 months
measure: Hospital Anxiety and Depression scale
timeFrame: At 12 months
measure: Hospital Anxiety and Depression scale
timeFrame: At 24 months
measure: Hospital Anxiety and Depression scale
timeFrame: At 36 months
measure: Hospital Anxiety and Depression scale
timeFrame: At 60 months
measure: Long term adverse Events associated with corticosteroid therapy.
timeFrame: 60 months
measure: Asthma-related comorbidities
timeFrame: At 6 months
measure: Asthma-related comorbidities
timeFrame: At 12 months
measure: Asthma-related comorbidities
timeFrame: At 24 months
measure: Asthma-related comorbidities
timeFrame: At 36 months
measure: Asthma-related comorbidities
timeFrame: At 60 months
measure: Death and cause of death
timeFrame: At 6 months
measure: Death and cause of death
timeFrame: At 12 months
measure: Death and cause of death
timeFrame: At 24 months
measure: Death and cause of death
timeFrame: At 36 months
measure: Death and cause of death
timeFrame: At 60 months
measure: Post-procedural adverse Events associated with bronchial thermoplasty
timeFrame: Up to 24 hours following the procedure
measure: Post-procedural adverse Events associated with bronchial thermoplasty
timeFrame: From 24 hours to 1 month following the procedure
measure: Long term adverse events associated with bronchial thermoplasty
timeFrame: 60 months
measure: Events of special interest
timeFrame: From treatment initiation to 3 months following treatment initiation
measure: Events of special interest
timeFrame: From 3 months to 12 months following treatment initiation
measure: Events of special interest
timeFrame: From 3 to 5 years following treatment initiation
measure: Blood eosinophil count
timeFrame: At baseline
measure: Total immunoglobulin E (IgE)
timeFrame: At baseline
measure: Chest computed tomography scan
timeFrame: At baseline
measure: Forced Vital Capacity (FVC)
timeFrame: At baseline
measure: Forced Vital Capacity (FVC)
timeFrame: At 6 months
measure: Forced Vital Capacity (FVC)
timeFrame: At 12 months
measure: Forced Vital Capacity (FVC)
timeFrame: At 24 months
measure: Forced Vital Capacity (FVC)
timeFrame: At 36 months
measure: Forced Vital Capacity (FVC)
timeFrame: At 60 months
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: At 6 months
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: At 12 months
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: At 24 months
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: At 36 months
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: At 60 months
measure: FEV1/FVC ratio
timeFrame: At baseline
measure: FEV1/FVC ratio
timeFrame: At 6 months
measure: FEV1/FVC ratio
timeFrame: At 12 months
measure: FEV1/FVC ratio
timeFrame: At 24 months
measure: FEV1/FVC ratio
timeFrame: At 36 months
measure: FEV1/FVC ratio
timeFrame: At 60 months
measure: RV/TLC ratio
timeFrame: At baseline
measure: RV/TLC ratio
timeFrame: At 6 months
measure: RV/TLC ratio
timeFrame: At 12 months
measure: RV/TLC ratio
timeFrame: At 24 months
measure: RV/TLC ratio
timeFrame: At 36 months
measure: RV/TLC ratio
timeFrame: At 60 months
measure: Fractional exhaled nitric oxide (FENO)
timeFrame: At baseline
measure: Costs of severe asthma management
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Bichat
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Camille TAILLE, MD,PHD
role: STUDY_CHAIR
References: