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A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

NCT04159519•AstraZeneca

View on ClinicalTrials.gov

Summary

This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.

Detailed Description

This study will be conducted at 24 study sites in 3-5 countries. The study duration for each participant will be approximately 52-56 weeks. Approximately 240 participants with severe eosinophilic asthma taking high-dose Inhaled corticosteroids/ long-acting β2-agonist (ICS/LABA) who have been treated for severe eosinophilic asthma with at least 3 consecutive doses of Fasenra® and have clinically responded since the start of Fasenra® treatment (defined for the purpose of this study as an Asthma control questionnaire-5 item (ACQ-5 score) \<1.5 at Visit 1 and Visit 2b) will be enrolled into this open-label study. The study consists of a Screening Visit (Visit 1) and 4- to 8-week screening and run-in period (to align the randomisation study visit with the next Fasenra® injection), a reduction period of 32 weeks, and a 16-week maintenance period.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of informed consent prior to any study-specific procedures.
•2. Patient must be aged 18 years old or above at the time of consenting to study participation.
•3. Documented current maintenance treatment with high-dose ICS/LABA.
•4. ACQ-5 score \<1.5 at Visit 1.
•5. Treatment with Fasenra® for the indicated diagnosis of severe eosinophilic asthma and has received at least 3 consecutive doses (\>8 weeks) prior to Visit 1.
•6. Male or female.
•7. Negative serum pregnancy test at Visit 1 for women of childbearing potential (WOCBP).
•8. WOCBP must agree to use a highly effective method of birth control (confirmed by the Investigator) from randomisation throughout the study duration and within 12 weeks after the last dose of study treatment. Highly effective forms of birth control (those that can achieve a failure rate of less than 1% per year when used consistently and correctly) include:
•* Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation-oral, intravaginal, or transdermal.
•* Progestogen-only hormonal contraception associated with inhibition of ovulation-oral, injectable, or implantable.
+14 more criteria

Exclusion Criteria

•1. As judged by the Investigator, any evidence of a severe or serious treatment-related AE during Fasenra® treatment which in the Investigator's opinion makes it undesirable for the patient to participate in the study.
•2. History of exacerbation requiring systemic corticosteroids or hospitalisation during the last 3 months prior to Visit 1 or during the run-in period.
•3. Clinically important pulmonary disease other than asthma (eg, active lung infection, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
•4. Current smokers or former smokers with a smoking history ≥20 pack/years.
•5. History of alcohol or drug abuse within 12 months prior to Visit 1.
•6. A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
•7. History of anaphylaxis to any biologic therapy.
•8. Known history of allergy or reaction to any component of the study treatment formulation.
•9. A history of known immunodeficiency disorder, including history of a positive human immunodeficiency virus (HIV) test.
•10. Current malignancy, or history of malignancy, except for:
+22 more criteria

Locations (23)

Research Site

Brest, France

Research Site

Dijon, France

Research Site

Le Kremlin-Bicêtre, France

Research Site

Lille, France

Research Site

Lyon, France

Research Site

Pessac, France

Research Site

Berlin, Germany

Research Site

Bonn, Germany

Research Site

Cottbus, Germany

Research Site

Hamburg, Germany

Key Dates

Start Date

July 27, 2020

Primary Completion Date

January 31, 2023

Completion Date

January 31, 2023

Last Updated

January 9, 2025

Enrollment

170

ACTUAL participants

Conditions

AsthmaSevere Eosinophilic Asthma

Interventions

Symbicort®

DRUG

Fasenra®

DRUG

Ventolin®

DRUG

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Asthma

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RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

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Asthma

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma