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New treatment option for Asthma; Eosinophilic
Official title Predictive Signature of Benralizumab Response
ClinicalTrials.gov ID: NCT04565483
What this study is testing
What is Benralizumab Prefilled Syringe?
Benralizumab Prefilled Syringe is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for asthma; eosinophilic.
Also referred to as Transcriptomic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients. This trial is a French, multicenter and no-randomized trial.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients between 18 and 75 years old.
- Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.:
- asthma requiring high doses of ICS (\>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to...
- and/or uncontrolled asthma despite the later medications,
- and/or a controlled asthma worsening after decreasing medications,
You likely can't join if
- Patients diagnosed with difficult-to-treat asthma and/or with uncontrolled asthma differential diagnosis according to the judgment of the...
- Non-adherent patients to inhaled treatment (ICS + LABA).
- Active smokers or former smokers exceeding 20 packs year.
- Exacerbation at inclusion visit M0.
- Active malignancy or malignancy in remission over less than 5 years.
- Active parasitic infection or parasitic infection in the past 24 weeks.
See the full eligibility criteria
- Patients between 18 and 75 years old.
- Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.:
- asthma requiring high doses of ICS (\>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to be controlled over one year,
- and/or uncontrolled asthma despite the later medications,
- and/or a controlled asthma worsening after decreasing medications,
- Documented historical reversibility of FEV1 ≥12% and FEV1 gain ≥ 200 milliliter
- ACQ-7 score ≥ 1,5 at M0.
- ≥ 3 exacerbations in the 12 months prior to screening visit M-1.
- Eosinophil blood count ≥ 0,3 G/L at inclusion visit or in the 12 months prior to the inclusion visit. If eosinophil blood count is ≥ 0,15 G/L and \< 0,3 G/L, an eosinophilic phenotype defined by at least 1 of the...
- Fractional Exhaled Nitric Oxide (FeNO) \> 25 ppm at inclusion visit or in the 12 months prior to the inclusion visit.
- Sputum eosinophils ≥ 3% at inclusion visit or in the 12 months prior to the inclusion visit.
- Patients who provide written informed consent prior to participation in the study
- Patients diagnosed with difficult-to-treat asthma and/or with uncontrolled asthma differential diagnosis according to the judgment of the investigator (e.g., vocal cord dysfunction, gastroesophageal reflux disease...
- Non-adherent patients to inhaled treatment (ICS + LABA).
- Active smokers or former smokers exceeding 20 packs year.
- Exacerbation at inclusion visit M0.
- Active malignancy or malignancy in remission over less than 5 years.
- Active parasitic infection or parasitic infection in the past 24 weeks.
- Hypersensitivity to Benralizumab or to any of the excipients of Fasenra® (histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20)
- Patients requiring other immunosuppressive and immunomodulator drugs
- Patients requiring other biotherapy than Benralizumab, with or without French's marketing authorisation in severe asthma
- Patients requiring other biotherapy than Benralizumab that affects the immune system
- SARS-COV2 infection
- Pregnancy, lactation, or patients with childbearing potential refusing efficient contraceptive method.
- Patients under psychiatric condition altering their comprehension and their ability to give informed consent.
- Patients already enrolled in a clinical treatment research.
- Patients not affiliated to a health insurance plan
- Patients under guardianship, curators or safeguard of justice
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, France
- Angers, France
- Bordeaux, France
- Brest, France
- Dijon, France
- Grenoble, France
- Le Kremlin-Bicêtre, France
- Le Mans, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Orléans, France
- Paris, France
- Rouen, France
- Strasbourg, France
- Suresnes, France
- Toulouse, France
- Villeurbanne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aix-en-Provence, France; Angers, France; Bordeaux, France; Brest, France; Dijon, France; Grenoble, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.