Registry of Asthma Patients Initiating DUPIXENT®

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life. This includes characterization of: Patient demographics (eg, gender, age, and race) Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height) The secondary objectives of the study are: To characterize real-world use patterns of DUPIXENT® for asthma To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT® To collect long-term safety data on study participants in the real-world setting

Detailed Description
-----------------
3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over

Official Title
-----------------
Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: DUPIXENT®


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Willing and able to comply with the required clinic visits, study procedures and assessments Able to understand and complete study-related questionnaires Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information Key Exclusion Criteria: Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DUPIXENT®|There is no investigational product provided by the study sponsor and no therapeutic intervention regulated by this protocol. As a condition for eligibility, patients are required to initiate DUPIXENT® for asthma, according to the country-specific prescribing information, prescribed by their physician as part of their normal care (ie, not for the purpose of enrolling in the registry). Once patients enter the study, there are no protocol requirements regarding DUPIXENT® or any other treatments.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demography | Including gender, age, race | At Baseline | 
| Baseline Characteristics | Including prior medications and procedures, medical history, asthma history, weight, height | At Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Treatment Characteristics | Including but not limited to treatment dose, frequency, duration and asthma treatment associations. | At Baseline | 
| Incidence of adverse events (AEs) | Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs | Baseline up to 3 years | 
| Physician Assessment: - Spirometry | Assessment collected as per standard of care. Includes forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow (FEF) between 25% to 75% of vital capacity (FEF25%-75%), post-bronchodilator FEV1. | Baseline up to 3 years | 
| Physician Assessment: Fractional exhaled Nitric Oxide (FeNO) | Assessment collected as per standard of care. | Baseline up to 3 Years | 
| Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6) | Questionnaire assessing the most common asthma symptoms during the previous week, using a 7-point Likert scale (0=fully controlled; 6=severely uncontrolled). Higher score indicates worse asthma control. | Baseline up to 3 Years | 
| Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ) | Questionnaire answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment). Higher score indicates less impact of asthma on quality of life. | Baseline up to 3 Years | 
| Patient Reported Outcome: Global Patient Assessment | Assessing patient's symptom severity over the past week and the patient's overall satisfaction with their asthma treatment. Higher scores indicate higher severity of asthma symptoms and lower satisfaction with asthma treatment. | Baseline up to 3 Years | 
| Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ) | Assessing patient's physical activity in their free time. Higher score indicates more health-related quality of life impairment. | Baseline up to 3 Years | 
| Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS) | Assessing severity of rhinits symptoms where higher score indicates more bothersome allergic symptoms. | Baseline up to 3 Years | 
| Patient Reported Outcome in patients with allergic rhinitis: Standardized Rhinoconjunctivitis Quality of Life Questionnaire for patients 12 years of age and older (RQLQ[S]+12) | Health-related quality of life signs and symptoms that are most problematic, as a result of perennial or seasonal allergic rhinitis. RQLQ(S)+12 responses are based on 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Higher score indicates more health-related quality of life impairment. | Baseline up to 3 Years | 
| Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22) | Questionnaire to assess the impact of chronic rhinosinusitis on quality of life. Lower score represents better health related quality of life. | Baseline up to 3 Years | 
| Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM) | Questionnaire assessing eczema severity with lower score representing impact of lower severity of less severe eczema. | Baseline up to 3 Years | 
| Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma) | Questionnaire to measure impairments in work and activities with higher score indicating greater impairment and less productivity. | Baseline up to 3 Years | 
| Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ) | The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma | Baseline up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Indication of Asthma