An observational study in Cystic Fibrosis, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by University Hospital, Montpellier · Observational
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.
•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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 100 is above the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CF patients (2 known variants) with hypereosinophilia ≥ 300/µl and uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)
Exclusion criteria
Clinical evolution
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 fibrosis
Time frame: 1 day
Spirometry in liters or percentage evolution
Spirometry in liters or percentage Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Time frame: 1 day
Biology evolution
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
Time frame: 1 day
concomitant therapy evolution
concomitant therapy Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Time frame: 1 day
CFQR and SNOT22 evolution
CFQR and SNOT22 questionnaires in score Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Time frame: 1 day
exacerbation evolution
Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Time frame: 1 day
Number of any adverse event reported during biotherapy treatments
Describe any adverse event potentially related to biotherapies. description of any adverse event reported during biotherapy treatments.
Time frame: 1 day
Plan to share: Undecided — NC
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier