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OpenTrials
Completed

NCT Number: NCT04991805

Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study

This is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies. The primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. The secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neoplasms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Stockholm, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study population includes patients with severe asthma recruited into ISAR and CHRONICLE. Severe asthma patients are defined as those receiving treatment consistent with Global Initiative for Asthma (GINA) Step 5 or who are uncontrolled on GINA Step 4 treatment regimens.

Exclusion criteria

  • Patients who are not willing and able to sign written informed consent

Treatment and study plan

Primary outcomes

  1. Neoplasm

    Time frame: Annually, up to 5 years

    Incidence of neoplasm each year, starting from index date.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2021
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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