CT Air-trapping for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients

NCT03976310 | Completed DMC

• 2 other identifiers: RECHMPL18_00162018-002292-18
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

BenraliScan aims to obtain thoracic computed tomography imaging data to predict the future level of patient response to a monoclonal antibody. Because the clinical responses under study can take many months to manifest, early identification of patients most-likely to benefit from treatment and treatment rule-out for others will save considerable time for everybody involved. The primary objective of BenraliScan is to determine the prognostic value (sensitivity, specificity, positive predictive value, negative predictive value) of air-trapping measures (Expiratory/Inspiratory ratios for Mean Lung Density (MLDe/i)) detected via quantitative thoracic computed tomography at baseline for improvement in exacerbation rate (the presence of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in baseline exacerbation rate) at 52 weeks among eosinophilic asthma patients treated with Benralizumab.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• The prognositc value (sensitivity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate

  The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate (the presence of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in baseline exacerbation rate) at week 52.

  52 weeks

• The prognositc value (specificity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate

  The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate (the presence of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in baseline exacerbation rate) at week 52.

  52 weeks

Secondary Outcomes (66)

• 52E: the number of exacerbations occurring during follow-up

  52 weeks

• 52cFEV1 pre BD: The change in forced expiratory volume in 1 second (FEV1) pre BD from baseline

  52 weeks

• 52cACQ: The change from baseline in the ACQ score

  52 weeks

• 52CI: A clinical improvement score

  52 weeks

• Concomitant medication use

  52 weeks

Study Arms (1)

The study population

OTHER

The study population corresponds to severe eosinophilic asthma patients (see eligibility criteria).

Drug: 48 weeks of Benralizumab; Other: Computed tomography

Interventions

48 weeks of Benralizumab DRUG

Benralizumab is administered for 48 weeks (week 0 to week 48) every 4 weeks for the first 3 injections (30 mg sc per injection), and then every 8 weeks for the following 5 injections.

The study population

Computed tomography OTHER

Computed tomography of the thorax is performed at the beginning (week 0), middle (week 24) and towards the end (week 48) of Benralizumab therapy. A sinus scan is also added on weeks 0 and 48.

The study population

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understanding and acceptance of the protocol
• The patient has given his/her informed consent and signed the consent form
• Affiliation with or beneficiary of the French national health insurance system
• Uncontrolled disease (Asthma Control Questionnaire \>1.5)
• Pre bronchodilator forced expiratory volume at 1 second (% predicted) between 40% and 85%, established according to the NHANESIII criteria
• Women of childbearing potential must use at least one acceptable and effective form of birth control
• Weight ≥ 40 kg

You may not qualify if:

• Other respiratory diseases or associated lung infections
• Patient deprived of liberty by judicial or administrative decision
• Major (adult) protected by the law (under any kind of guardianship)
• Patient who participated in another research protocol with X-ray exposure in the past 12 months
• Patient who has already participated in the present protocol
• Hypersensitivity to benralizumab or to any of the excipients: histidine, histidine hydrochloride monohydrate, trehalose dehydrate, polysorbate 20 and water for injections
• Subjects with untreated helminthic parasitic infection
• Lactating or pregnant\* females or females who intend to become pregnant
• Subjects with a history of anaphylaxis to any biologic therapy
• Subjects taking immunosuppressive medications (except oral prednisone and inhaled and topical corticosteroids)
• Subjects with intercurrent illnesses (eg, viral illnesses) that may compromise the safety of the subject
• Subjects who are febrile (≥ 38°C)
• Currently smoking or smoking history ≥ 20 pack years
• Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date of informed consent, and assent when applicable was obtained
• Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date of informed consent, and assent when applicable, was obtained

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• AstraZeneca: collaborator

Study Sites (2)

Assistance Publique - Hopitaux de Marseille

Marseille, 13915, France

Location

University Hospitals of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Asthma

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sébastien Bommart, MD PhD

  University Hospitals of Montpellier, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This single arm protocol will study individual patient responses to 12 months of benralizumab treatment and early means of detecting them. The model is a prognostic study that will use information detected via baseline quantitative thoracic computed tomography for predicting improvement in exacerbation rate 52 weeks after the start of treatment.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: June 20, 2019
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: July 18, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)