A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Purpose
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.
Condition
- Asthma
Eligibility
- Eligible Ages
- Over 6 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Part-1: Participants With Asthma | Participants receiving treatment with low-, medium-, or high-dose inhaled corticosteroids (ICS) and/or biologic therapies as part of standard of care (SoC) for the management of asthma in routine clinical practice. |
|
| Part-2: A1- Uncontrolled Asthma Cohort | Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of greater than or equal to (>=)1.5 |
|
| Part-2: A2- Controlled Asthma Cohort | Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (<)1.5 |
|
| Part-2: B1- Type-2 (T2) High Asthma Cohort | Participants receiving SoC with elevated T2 biomarkers |
|
| Part-2: B2- Type-2 Low Asthma Cohort | Participants receiving SoC with low T2 biomarkers |
|
Recruiting Locations
Chandler, Arizona 85224
Mesa, Arizona 85206
Sun City, Arizona 85351
California City, California 91107
La Palma, California 90623
Newport Beach, California 92663
Pasadena, California 91101
Tarzana, California 91356
Walnut Creek, California 94598
Altamonte Springs, Florida 32701
Boca Raton, Florida 33431
Brandon, Florida 33511
Greenacres City, Florida 33467
Miami, Florida 33126
Miami, Florida 33126
Miami, Florida 33130
Miami, Florida 33142
Miami, Florida 33155
Miami, Florida 33173
Miami, Florida 33174
Miami, Florida 33186
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Miami Lakes, Florida 33016
North Miami Beach, Florida 33169
Plantation, Florida 33317
Port Saint Lucie, Florida 34986
Tampa, Florida 33613
West Palm Beach, Florida 33409
Columbus, Georgia 31904
Chicago, Illinois 60616
Lexington, Kentucky 40509
Rockville, Maryland 20854
Missoula, Montana 59808
Papillion, Nebraska 68046
Sewell, New Jersey 08080
Cortland, New York 13045
New Windsor, New York 12553
Asheville, North Carolina 28801
Lima, Ohio 45801
Toledo, Ohio 43617
Pittsburgh, Pennsylvania 15241
Rock Hill, South Carolina 29732
Tennessee City, Tennessee 30909
Dallas, Texas 75235
El Paso, Texas 79902
Houston, Texas 77090
Houston, Texas 77099
Hurst, Texas 76054
Tomball, Texas 77081
Bellingham, Washington 98225
More Details
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended-Toll free for US & Canada800-633-1610
Contact-US@sanofi.com