Anti-IL5 and Other Biotherapies in Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT04256772
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
Our project is to describe retrospectively and prospectively CF patients treated with biotherapy in French CF centers.
Main objective: To describe the clinical and paraclinical course of CF patients before and after treatment with anti-IL5 and other biotherapies since 2019.
Secondary objective: To describe adverse events potentially related to the biotherapies.
- Detailed Description
•Background: ABPA and asthma associated with cystic fibrosis impact the CF course with a more rapid decline in lung function.
Corticosteroid therapy can be harmful and must be avoid in CF to prevent diabetes, osteoporomalacia or mycobacterium infections.
Monoclonal antibodies have the marketing authorization for severe uncontrolled asthma and, up to now, some CF patients with ABPA or severe asthma and high plasma IgE levels benefit from omalizumab.
Anti-Il5 agents are available since February 2019 and have demonstrated their efficacy in severe and hypereosinophilic asthma control (plasma eos.\>300mmol/L).
Some patients with CF who have severe asthma or ABPA are still poorly controlled despite Omalizumab with other treatments (steroids and/or azoles). Some of them have persistent hypereosinophilia suggesting a possibility to treat with antiIL5 antibodies.
About 5% of patients have biotherapy treatment criteria, some have already received it, others are elective to such treatment and will receive in the future.
Methods:
Our project is to describe retrospectively and prospectively the clinical history of CF patients eligible for biotherapy in French CF centers.
Main objective: To describe the clinical and paraclinical course of CF patients before and after treatment with anti-IL5 and other biotherapies since 2019.
Secondary objective: To describe any adverse events potentially related to the biotherapies.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical evolution 1 day Physical examination (height in centimeters, weight in kilograms, numerical scales in score, temperature in degrees, SaO2 in percentage).
Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis To assess the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosisSpirometry in liters or percentage evolution 1 day Spirometry in liters or percentage Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Biology evolution 1 day Biology (leukocyte formula in 10\^9/L, IgE tot, IgE spe, sputum microbiology) Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
concomitant therapy evolution 1 day concomitant therapy Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
CFQR and SNOT22 evolution 1 day CFQR and SNOT22 questionnaires in score Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
exacerbation evolution 1 day Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
- Secondary Outcome Measures
Name Time Method Number of any adverse event reported during biotherapy treatments 1 day Describe any adverse event potentially related to biotherapies. description of any adverse event reported during biotherapy treatments.
Trial Locations
- Locations (1)
Uh Montpellier
🇫🇷Montpellier, France