SHAMAL
Research type
Research Study
Full title
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
IRAS ID
269265
Contact name
Katherine Murtagh
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-001924-37
Duration of Study in the UK
1 years, 10 months, 2 days
Research summary
Approximately 5-10% of people with asthma have a form called severe eosinophilic asthma. Current treatment is based on use of daily inhalers, inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs), and a reliever inhaler (rapid action inhaler used during an asthma attack, e.g. salbutamol). Symbicort is a combination ICS/LABA that can be used both for daily asthma maintenance and as a reliever. This is called “SMART” therapy (Symbicort Maintenance and Reliever Therapy).
Biologic therapies, such as Fasenra®, target elements of the immune system which increase inflammation and are recommended as add-on treatment in patients whose asthma is uncontrolled with high dose ICS/LABA treatment.
According to current guidelines doctors should consider reducing ICS/LABA maintenance dose for patients who have good asthma control. However, reducing the dose of ICS/LABA in patients taking a biologic for severe asthma has not been tested. In the future, if shown to be safe and effective, doctors are likely to reduce the ICS/LABA dose significantly, or completely, in patients whose asthma becomes well controlled after addition of biologic therapy.
There are currently no studies published which assess the reduction of background SMART treatment in severe eosinophilic asthma patients while on biologic therapy. There’s also no standardised plan for reduction of SMART treatment and no data to guide doctors on how to safely reduce the ICS/LABA dose in patients responding well to biologic therapy.
The proposed study (sponsored by AstraZeneca) will address these evidence gaps and provide clear guidance on the safe and effective reduction of SMART therapy while protecting against asthma worsening in patients taking Fasenra.
The objective of this study is to assess the potential for Fasenra®-treated severe eosinophilic asthma patients to safely and effectively reduce their SMART (Symbicort®) treatment from a daily high-dose to use as a reliever only. This study will recruit approximately 240 participants.
Lay summary of study results: The Lay summary for this study is not available at this time, publication is planned in upcoming months.
Once published the lay summary will be available on ClinicalTrials.gov.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: We are planning to publish the Shamal study results on ctgov by 31 Jan 2024. At this stage it is unknown when full results including substudy will be available.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/1628
Date of REC Opinion
7 Jan 2020
REC opinion
Further Information Favourable Opinion