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

Part of paid clinical trials in Walnut Creek, California.

Sponsor
Sanofi
Study ID
NCT07556159
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Procedure: Investigational Procedures — OTHER
    Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.
  • Procedure: Investigational Procedures — OTHER
    Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Apr 4, 2029
Completion
Apr 4, 2029

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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
  • Arm: Part-2: A2- Controlled Asthma Cohort
    Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (\<)1.5
  • Arm: Part-2: B1- Type-2 (T2) High Asthma Cohort
    Participants receiving SoC with elevated T2 biomarkers
  • Arm: Part-2: B2- Type-2 Low Asthma Cohort
    Participants receiving SoC with low T2 biomarkers

Primary Outcome Measure

Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities [ Time Frame: Part 1: At baseline ]

Central Contacts

  • Trial Transparency email recommended-Toll free for US & Canada
    800-633-1610
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Research of California - Site Number: 840145Walnut CreekCalifornia94598-
L&A Morales Healthcare, Inc - Site Number: 840102MiamiFlorida33142-
Montana Medical Research - Site Number: 840137MissoulaMontana59808-
Pioneer Research Solutions - Site Number: 840104HoustonTexas77099-

Find similar trials in Walnut Creek, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Clinical Research of California· Walnut Creek, CAL&A Morales Healthcare, Inc· Miami, FLMontana Medical Research· Missoula, MTPioneer Research Solutions· Houston, TX

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