Clinical trial NCT04256772: Anti-IL5 and Other Biotherapies in Cystic Fibrosis
Official title: Anti-IL5 and Other Biotherapies in Cystic Fibrosis in French CF Centers : MAB-CF Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: CYSTIC FIBROSIS
BIOTHERAPY
ANTI-IL5
BENRALIZUMAB
APBA
SEVERE ASTHMA
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CF patients (2 known variants) with hypereosinophilia ≥ 300/µl and uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)

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.

Eligibility criteria: Inclusion criteria:

* Cystic fibrosis (2 known variants)
* Age ≥ 6 years
* Plasma hypereosinophilia ≥ 300/µl
* Uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)

Exclusion criteria

- Refusal to participate in this research

Primary outcomes:
measure: Clinical evolution
timeFrame: 1 day
measure: Spirometry in liters or percentage evolution
timeFrame: 1 day
measure: Biology evolution
timeFrame: 1 day
measure: concomitant therapy evolution
timeFrame: 1 day
measure: CFQR and SNOT22 evolution
timeFrame: 1 day
measure: exacerbation evolution
timeFrame: 1 day
Secondary outcomes:
measure: Number of any adverse event reported during biotherapy treatments
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Raphael CHIRON, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: