RecruitingNot Applicable

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

United States2,500 participantsStarted 2026-04-01

Plain-language summary

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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities

Timeframe: Part 1: At baseline

Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma

Timeframe: Part 1: At baseline

Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma

Timeframe: Part 1: At baseline

Part 1: Physician Global Assessment of Asthma Severity and Symptom Control

Timeframe: Part 1: At baseline

Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2

Timeframe: Part 2: At Weeks 52 and 104

Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2

Timeframe: Part 2: At Weeks 52 and 104

Part 2: Descriptive Statistical Analysis of Difference in Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV₁) between Part 2 Cohorts B1 and Cohort B2

Trial details

NCT IDNCT07556159

SponsorSanofi

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-04-04

Contact for this trial

Trial Transparency email recommended-Toll free for US & Canada

800-633-1610 Contact-US@sanofi.com

View on ClinicalTrials.gov More Asthma trials

Plain-language summary

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

What they're measuring

Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities

Timeframe: Part 1: At baseline

Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma

Timeframe: Part 1: At baseline

Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma

Timeframe: Part 1: At baseline

Part 1: Physician Global Assessment of Asthma Severity and Symptom Control

Timeframe: Part 1: At baseline

Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2

Timeframe: Part 2: At Weeks 52 and 104

Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2

Timeframe: Part 2: At Weeks 52 and 104

Part 2: Descriptive Statistical Analysis of Difference in Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV₁) between Part 2 Cohorts B1 and Cohort B2