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

ArmDescriptionAssigned 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.
  • Other: Procedure: Investigational Procedures
    Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.
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
  • Other: Procedure: Investigational Procedures
    Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Part-2: A2- Controlled Asthma Cohort Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (<)1.5
  • Other: Procedure: Investigational Procedures
    Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Part-2: B1- Type-2 (T2) High Asthma Cohort Participants receiving SoC with elevated T2 biomarkers
  • Other: Procedure: Investigational Procedures
    Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Part-2: B2- Type-2 Low Asthma Cohort Participants receiving SoC with low T2 biomarkers
  • Other: Procedure: Investigational Procedures
    Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.

Recruiting Locations

Clinical Research of California - Site Number: 840145
Walnut Creek, California 94598

L&A Morales Healthcare, Inc - Site Number: 840102
Miami, Florida 33142

Montana Medical Research - Site Number: 840137
Missoula, Montana 59808

Pioneer Research Solutions - Site Number: 840104
Houston, Texas 77099

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended-Toll free for US & Canada
800-633-1610
Contact-US@sanofi.com