Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT) (REVEAL)

Sanofi

Status

Active, not recruiting

Conditions

Asthma

Treatments

Drug: Dupilumab SAR231893

Study type

Observational

Funder types

Industry

Identifiers

NCT04550962

OBS16688

Details and patient eligibility

About

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.

Full description

Each patient will be followed during 36 months.

Enrollment

375 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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.