NCT04256772

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

January 27, 2020

Last Update Submit

July 28, 2020

Conditions

Cystic Fibrosis

Keywords

CYSTIC FIBROSISBIOTHERAPYANTI-IL5BENRALIZUMABAPBASEVERE ASTHMA

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    1 day

  • concomitant therapy evolution

    concomitant therapy Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis

    1 day

  • CFQR and SNOT22 evolution

    CFQR and SNOT22 questionnaires in score Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis

    1 day

  • exacerbation evolution

    Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis

    1 day

Secondary Outcomes (1)

  • Number of any adverse event reported during biotherapy treatments

    1 day

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

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

You may not qualify if:

  • \- Refusal to participate in this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Cystic FibrosisAsthma

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Raphael CHIRON, PU-PH

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 5, 2020

Study Start

July 1, 2019

Primary Completion

June 1, 2020

Study Completion

March 31, 2022

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

FR(1)