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A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice

RecruitingN/A

Sponsor: Sanofi

Conditions: Asthma

Interventions: Procedure: Investigational Procedures, Procedure: Investigational Procedures

Countries: United States, Canada, Japan

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.

Eligibility overview

Sex: ALL

Age: 6 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

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:

A) Asthma control cohorts

1. ACQ-5 \>= 1.5
2. ACQ-5 \< 1.5 (B) Type-2 biomarker cohorts
3. Elevated T2 biomarkers (B1: Type-2-high cohort)
4. 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.

Locations (54)

Chandler, Arizona, United States
Mesa, Arizona, United States
Sun City, Arizona, United States
California City, California, United States
La Palma, California, United States
Newport Beach, California, United States
Pasadena, California, United States
Tarzana, California, United States
Walnut Creek, California, United States
Altamonte Springs, Florida, United States
Boca Raton, Florida, United States
Brandon, Florida, United States
Greenacres City, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
North Miami Beach, Florida, United States
Plantation, Florida, United States
Port Saint Lucie, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Columbus, Georgia, United States
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