Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)
Study of Investigational Medication for Asthma in Real-World Settings
Study Overview
Primary Objective:
The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma.
Secondary Objectives:
The secondary objectives of the study are:
- To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching)
- To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control)
- To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent
- To collect data on HealthCare Resource Utilization (HCRU)
- To collect safety data on study participants in the real-world setting.
Study Details
Each patient will be followed during 36 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Asthma
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Age: 12 years or above
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Gender: All
- Male or female, 12 years or older Initiating treatment with Dupixent for asthma according
to the country-specific prescribing information Willing and able to comply with the required clinic visits, study procedures and assessments.
Provided signed informed consent
- Most important exclusion criteria for potential participants Patients who have a contraindication to Dupixent according to the country-specific prescribing information Treatment with Dupixent within 6 months before the baseline visit. Note: for patients who have been treated previously with DUPIXENT a washout period of 6 months is required before Visit 1.
Any condition that, in the opinion of the Investigator, may interfere with patient's
ability to participate in the study, such as short life expectancy, substance abuse, severe
cognitive impairment, or other comorbidities that can predictably prevent the patient from
adequately completing the schedule of visits and assessments Patients currently
participating in any interventional clinical trial which modifies patient care.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
This study investigates the use of an investigational medication for asthma in real-world settings. Asthma is a condition where the airways in the lungs become narrow and swollen, making it hard to breathe. The study will look at patients' medical histories, including their asthma history and treatments, as well as other factors like age and other medicines they are taking.
Participants will undergo various procedures to collect data on how the investigational medication affects their asthma. This includes checking lung function, monitoring asthma attacks, and understanding how well asthma is controlled. The study will also gather information about other related health conditions and the overall safety of the medication.
- Who can participate: The study is open to males and females aged 12 years or older who are starting treatment with the investigational medication for asthma. Participants must be willing to attend clinic visits and follow study procedures. They must not have used the investigational medication within 6 months prior to the study.
- Study details: Participants will be required to attend clinic visits and complete study assessments. The study will involve monitoring lung function and asthma control.
- Study Timelines: The study will last 36 months.
