Asthma
Conditions
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.
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous Dose regimen:
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Characteristics: Socio-demographics | At baseline | Socio-demographics including but not limited to gender, age, race, weight, and height |
| Baseline Characteristics: Medical history | At baseline | Including asthma history and asthma treatment history |
| Baseline Characteristics: Disease characteristics | At baseline | Disease characteristics including asthma, comorbid conditions, family history and history of inflammatory diseases |
| Baseline Characteristics: Biomarkers | At baseline | Including fractional exhaled nitric oxide (FeNo), blood eosinophils count, immunoglobulin E (IgE total/specific) |
| Baseline Characteristics: Concomitant treatments for asthma | At baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dupixent and other asthma treatment use patterns | Baseline to Month 36 | Including doses and dose frequency, treatment duration, asthma treatment associations (eg, Dupixent monotherapy, Dupixent + inhaled corticosteroids (ICS), Dupixent + ICS + additional controllers, oral corticosteroid (OCS) burst), and reasons for initiation and for discontinuation/switching. |
| Lung function | Baseline to Month 36 | Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time. |
| Annualized exacerbation rate | Baseline to Month 36 | A severe exacerbation event is defined as a deterioration of asthma requiring: * Use of systemic corticosteroids for ≥3 days; or * Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. |
| Patient reported outcomes: Asthma Control Questionnaire (6-item) (ACQ-6) | Baseline to Month 36 | To evaluate asthma control |
| Patient reported outcomes: Patient Oriented Eczema Measure (POEM) among participants with atopic dermatitis | Baseline to Month 36 | Among participants with atopic dermatitis |
| Patient reported outcomes: Allergic Rhinitis Visual Analogue Scale (AR-VAS) among participants with allergic rhinitis | Baseline to Month 36 | Among participants with allergic rhinitis |
| Patient reported outcomes: Sino-nasal Outcome Test (SNOT-22) | Baseline to Month 36 | Among participants with chronic rhinosinusitis with nasal polyps \[CRSwNP\] and chronic rhinosinusitis \[CRS\] without nasal polyps \[NP\]) |
| Healthcare Resource Utilization | Baseline to Month 36 | The Healthcare Resource Utilization (HCRU) collects information on unscheduled healthcare resource encounters including inpatient visits, emergency room visits, physician office visits related to asthma, including the dates of visits and duration of any hospitalizations, together with the reason for the visits |
| Number of participants with adverse events (AE) and serious adverse events (SAE) | Baseline to Month 36 | — |
Countries
Argentina, Chile, Colombia, Israel, Kuwait, Lebanon, Mexico, Qatar, Russia, Saudi Arabia, Singapore, United Arab Emirates
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed