Asthma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: I 01. Male or female, aged =12 years at the baseline visit I 02. Confirmed diagnosis of asthma based on Global Initiative for Asthma (GINA) and/or Chinese criteria (i.e., Guidelines for Bronchial Asthma Prevent and Management). I 03. Initiating Dupixent treatment for asthma (by physician’s discretion) I 04. Willing and able to comply with required ICF as well as clinic visits, study procedures and assessments I 05. Able to understand and complete study-related questionnaires I 06. Willing to participate in the study voluntarily and sign the written informed consent. • For participants aged 12-18 years (=12 years but <18 years), written informed consent must be obtained from both the participant and his/her legal guardian.
Exclusion criteria
Exclusion criteria: E 01. Participants who have a contraindication to Dupixent E 02. Treatment with Dupixent within 6 months before the baseline visit E 03. Any condition that, in the opinion of the investigator, may interfere with participant’s ability to participate in the study, such as short life expectancy, severe cognitive impairment, or other comorbid disease(s) that can predictably prevent the participant from adequately completing the schedule of visits and assessments. E 04. Currently participating in any non-Sanofi sponsored clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Socio-demographics (gender, age, smoking status, etc.).;Clinical characteristics (medical/surgical history, prior/concomitant treatments, inflammatory biomarkers, lung function, etc.).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in annualized exacerbation rate in the 12-month post dupilumab initiation compared to 12-month baseline annualized exacerbation rate.;Absolute and percent change from baseline in pre-and post-bronchodilator Forced Expiratory Volume in one second (FEV1) at Weeks 24 and 52.;Absolute and percent change from baseline in pre-and post-bronchodilator Forced Vital Capacity (FVC) at Weeks 24 and 52.;Absolute and percent change from baseline in Forced mid-Expiratory Flow (FEF)25%-75% at Weeks 24 and 52.;Absolute and percent change from baseline in pre-and post-bronchodilator Peak Expiratory Flow (PEF) at Weeks 24 and 52.;Change from baseline in inflammatory biomarkers (EOS, FeNO, IgE) at Weeks 24 and 52.;Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) at Weeks 24 and 52.;Change from baseline in Mini Asthma Quality of Life Questionnaire (= 17 years)(MiniAQLQ) at Weeks 24 and 52.;Change from baseline in Pediatric Asthma Quality of Life Questionnaire (<17 years) (PAQLQ) from baseline at Weeks 24 and 52.;Incidence of adverse events in follow-up period.;Dupilumab dosage, frequency, duration and other asthma treatment patterns (e.g., medium, high dose inhale corticosteroids [ICS] and/or long-acting inhale beta2-agonist (LABA) and/or long-acting muscarinic antagonists (LAMA) and/or oral corticosteroids [OCS]).;Reasons for initiation and discontinuation/switching/adjustment of dupilumab.;Change in the proportion of patients treated with maintenance oral corticosteroids (mOCS) in the 12-month post dupilumab initiation compared to 12-month baseline.;Change in daily mOCS dose in the 12-month post dupilumab initiation compared to 12-month baseline.;Concomitant treatments.;Change from baseline in HCRU at Week 24 and 52.;Change from baseline in Allergic Rhinitis Visual Analogue Scale (AR-VAS, for those with allergic rhinitis), Sino-Nasal Outcome Test (SNOT-22, for those with chronic rhinosinusitis [CRS]), Patient Oriented Eczema Measure (POEM, for those with atopic de | — |
Countries
China
Contacts
Public ContactQingling ZHANG
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed