Asthma
Conditions
Keywords
Primary Indication of Asthma
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
Interventions
DRUGDUPIXENT®
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.
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demography | At Baseline | Including gender, age, race |
| Baseline Characteristics | At Baseline | Including prior medications and procedures, medical history, asthma history, weight, height |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Treatment Characteristics | At Baseline | Including but not limited to treatment dose, frequency, duration and asthma treatment associations. |
| Incidence of adverse events (AEs) | Baseline up to 3 years | Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs |
| Physician Assessment: - Spirometry | Baseline up to 3 years | 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. |
| Physician Assessment: Fractional exhaled Nitric Oxide (FeNO) | Baseline up to 3 Years | Assessment collected as per standard of care. |
| Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6) | Baseline up to 3 Years | 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. |
| Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ) | Baseline up to 3 Years | 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. |
| Patient Reported Outcome: Global Patient Assessment | Baseline up to 3 Years | 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. |
| Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ) | Baseline up to 3 Years | Assessing patient's physical activity in their free time. Higher score indicates more health-related quality of life impairment. |
| Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS) | Baseline up to 3 Years | Assessing severity of rhinits symptoms where higher score indicates more bothersome allergic symptoms. |
| 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) | Baseline up to 3 Years | 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. |
| Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22) | Baseline up to 3 Years | Questionnaire to assess the impact of chronic rhinosinusitis on quality of life. Lower score represents better health related quality of life. |
| Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM) | Baseline up to 3 Years | Questionnaire assessing eczema severity with lower score representing impact of lower severity of less severe eczema. |
| Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma) | Baseline up to 3 Years | Questionnaire to measure impairments in work and activities with higher score indicating greater impairment and less productivity. |
| Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ) | Baseline up to 3 years | The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma |
Countries
Canada, Denmark, France, Italy, Japan, Puerto Rico, Spain, Sweden, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed