PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 376
- Locations
- 41
- Primary Endpoint
- Baseline Characteristics: Medical history
Study Overview
Brief Summary
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.
Detailed Description
Each patient will be followed for up to 36 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Participants with asthma
Eligible participants are initiating treatment with Dupixent for asthma according to the prescribing information in effect in each country
Intervention: Dupilumab SAR231893 (Drug)
Outcomes
Primary Outcomes
Baseline Characteristics: Medical history
Time Frame: At baseline
Including asthma history and asthma treatment history
Baseline Characteristics: Concomitant treatments for asthma
Time Frame: At baseline
Baseline Characteristics: Socio-demographics
Time Frame: At baseline
Socio-demographics including but not limited to gender, age, race, weight, and height
Baseline Characteristics: Disease characteristics
Time Frame: At baseline
Disease characteristics including asthma, comorbid conditions, family history and history of inflammatory diseases
Baseline Characteristics: Biomarkers
Time Frame: At baseline
Including fractional exhaled nitric oxide (FeNo), blood eosinophils count, immunoglobulin E (IgE total/specific)
Secondary Outcomes
- Dupixent and other asthma treatment use patterns(Baseline to Month 36)
- Lung function(Baseline to Month 36)
- Annualized exacerbation rate(Baseline to Month 36)
- Patient reported outcomes: Asthma Control Questionnaire (6-item) (ACQ-6)(Baseline to Month 36)
- Patient reported outcomes: Patient Oriented Eczema Measure (POEM) among participants with atopic dermatitis(Baseline to Month 36)
- Patient reported outcomes: Allergic Rhinitis Visual Analogue Scale (AR-VAS) among participants with allergic rhinitis(Baseline to Month 36)
- Patient reported outcomes: Sino-nasal Outcome Test (SNOT-22)(Baseline to Month 36)
- Healthcare Resource Utilization(Baseline to Month 36)
- Number of participants with adverse events (AE) and serious adverse events (SAE)(Baseline to Month 36)