Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Disea… (NCT04550962) | Clinical Trial Compass
CompletedNot Applicable
Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)
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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline Characteristics: Socio-demographics
Timeframe: At baseline
2
Baseline Characteristics: Medical history
Timeframe: At baseline
3
Baseline Characteristics: Disease characteristics
Timeframe: At baseline
4
Baseline Characteristics: Biomarkers
Timeframe: At baseline
5
Baseline Characteristics: Concomitant treatments for asthma