Cystic FibrosisMAB-CFNCT04256772
Anti-IL5 and Other Biotherapies in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CF patients (2 known variants) with hypereosinophilia ≥ 300/µl and uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)
Who may be able to join
- Cystic fibrosis (2 known variants)
- Age ≥ 6 years
- Plasma hypereosinophilia ≥ 300/µl
- Uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)
Who cannot join
- Refusal to participate in this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-IL5 and Other Biotherapies in Cystic Fibrosis in French CF Centers : MAB-CF Cohort
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- CYSTIC FIBROSIS, BIOTHERAPY, ANTI-IL5, BENRALIZUMAB, APBA, SEVERE ASTHMA
- Medical subject headings
- Cystic Fibrosis, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 day
concomitant therapy evolution
concomitant therapy Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Measured: 1 day
CFQR and SNOT22 evolution
CFQR and SNOT22 questionnaires in score Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Measured: 1 day
exacerbation evolution
Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jul 2019
- Primary completion1 Jun 2020
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael CHIRON, PU-PH, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256772
- Sponsor's protocol ID
- RECHMPL19_0563
- Acronym
- MAB-CF
- Status last verified
- Jul 2020
- First submitted
- 27 Jan 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-IL5 and Other Biotherapies in Cystic Fibrosis in French CF Centers : MAB-CF Cohort
- ClinicalTrials.gov ID
- NCT04256772
- Acronym / sponsor ID
- MAB-CF / RECHMPL19_0563
- Conditions
- Cystic Fibrosis
- Keywords
- CYSTIC FIBROSIS, BIOTHERAPY, ANTI-IL5, BENRALIZUMAB, APBA, SEVERE ASTHMA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CF patients (2 known variants) with hypereosinophilia ≥ 300/µl and uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)
Key inclusion criteria (4 listed)
- Cystic fibrosis (2 known variants)
- Age ≥ 6 years
- Plasma hypereosinophilia ≥ 300/µl
- Uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)
Key exclusion criteria (1 listed)
- Refusal to participate in this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical evolution
Time frame: 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 fibrosis
Spirometry in liters or percentage evolution
Time frame: 1 day
Spirometry in liters or percentage Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Biology evolution
Time frame: 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
Time frame: 1 day
concomitant therapy Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
CFQR and SNOT22 evolution
Time frame: 1 day
CFQR and SNOT22 questionnaires in score Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
exacerbation evolution
Time frame: 1 day
Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
1 secondary outcome
Number of any adverse event reported during biotherapy treatments
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael CHIRON, PU-PH principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.