Recruiting

Observational Study

Sponsor:

Sanofi

Code:

NCT07556159

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Procedure: Investigational Procedures

Procedure: Investigational Procedures

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT07556159

Start date

Apr 1, 2026

Status verified date

Sep, 2026

Completion date

Apr 4, 2029

Anticipated

Primary completion date

Apr 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Procedure: Investigational Procedures

Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.

Procedure: Investigational Procedures

Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.

Primary outcome measure

  • Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities [ Time Frame: Part 1: At baseline ]
  • Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma [ Time Frame: Part 1: At baseline ]
  • Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma [ Time Frame: Part 1: At baseline ]
  • Part 1: Physician Global Assessment of Asthma Severity and Symptom Control [ Time Frame: Part 1: At baseline ]
  • Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2 [ Time Frame: Part 2: At Weeks 52 and 104 ]
  • Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2 [ Time Frame: 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 [ Time Frame: Part-2: At Weeks 52 and 104 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended-Toll free for US & Canada

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

Locations

Trinity Clinical Research, LLC - Bessemer - Site Number: 840150

Recruiting

Bessemer, Alabama, United States, 35022

Orso Health - Scottsdale - Site Number: 840133

Recruiting

Scottsdale, Arizona, United States, 85254

Columbia Medical Practice - Site Number: 840172

Recruiting

Columbia, Maryland, United States, 21045

University of Michigan - Ann Arbor - Site Number: 840140

Recruiting

Ann Arbor, Michigan, United States, 48109

East Carolina University Physicians - Pulmonary and Critical Care Medicine - Site Number: 840142

Recruiting

Greenville, North Carolina, United States, 27834-2849

Investigational Site Number: 124203

Recruiting

Calgary, Alberta, Canada, T3R 1W7

Investigational Site Number: 124201

Recruiting

Windsor, Ontario, Canada, N8X 2G1

Investigational Site Number: 124204

Recruiting

Trois-Rivières, Quebec, Canada, G8T7A1

More Information

Sponsor

Sanofi

Last update posted

Oct 9, 2026

Last verified

Sep, 2026

Keywords

  • Cross-Sectional
  • Multicenter
  • Inhaled Corticosteroids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.