Studying how asthma affects people in everyday care
Observes people with asthma to describe their symptoms, treatment and daily burden.
Plain-language title generated from the registry record
Registry title: A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Key facts
- Where
- Brescia, Catanzaro, Genoa, Milan, Montebelluna, Palermo, and Rozzano, ItalySee the 7 sites
- Phase
- Phase 4
Where in Italy
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyNot yet recruiting
- IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyNot yet recruiting
- ASST Fatebenefratelli SaccoMilan, ItalyNot yet recruiting
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca TrevigianaMontebelluna, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07556159EU 2025-524916-13-00
- Record updated
- 5 November 2026
- Original description
The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life.Read full original descriptionShow less
A Hybrid Cross-sectional and Prospective Study to Assess Patient Characteristics, Disease Burden, Disease Control, Phenotypes, Endotypes, and Outcomes in a Real-world Setting in Patients With Asthma
The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life.
The study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.
Inclusion: Applicable for Part 1 participants:; Age 6 years and older, at the time of signing the informed consent; Physician diagnosis of asthma for at least 12 months; Existing treatment with low, medium, or high dose ICS and other asthma therapies as reflected in GINA 2-5 steps; Participant or legally authorized representative (where applicable) has consented to participate; Applicable for Part 2 participants:; Age 18 years and older, at the time of signing the informed consent; Physician diagnosis of asthma for at least 12 months; Existing treatment with low or medium ICS and other asthma therapies as reflected in GINA 2-4 steps; Participant or legally authorized representative (where applicable) has consented to participate; Participants must meet the criteria for at least one of the cohorts below:; Asthma control cohorts; ACQ-5 >= 1.5; ACQ-5 < 1.5 (B) Type-2 biomarker cohorts; Elevated T2 biomarkers (B1: Type-2-high cohort); Low T2 biomarkers (B2: Type-2-low cohort); Participants are excluded from the study if any of the following criteria apply (applicable for both Part 1 and Part 2 participants):; Current diagnosis of chronic obstructive pulmonary disease (COPD) or congestive heart failure; Participants with moderate/severe cognitive impairment; Participants with moderate/severe cardiac disease; Participants on immunosuppressive medication for a chronic condition; Participation in other interventional and noninterventional clinical study (currently or in the past 3 months); The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.