Recruiting

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

Sponsor:

Sanofi

Code:

NCT07556159

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

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

Aug, 2026

Completion date

Apr 4, 2029

Anticipated

Primary completion date

Apr 4, 2029

Anticipated

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

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

Locations

Chandler Clinical Trials - Site Number: 840106

Recruiting

Chandler, Arizona, United States, 85224

Del Sol Research Management, LLC - Mesa - Site Number: 840123

Recruiting

Mesa, Arizona, United States, 85206

Sun City Clinical Trials - Elite - Site Number: 840120

Recruiting

Sun City, Arizona, United States, 85351

FOMAT - Huntington Asthma & Allergy Center - Site Number: 840158

Recruiting

California City, California, United States, 91107

Imax Clinical Trials - Site Number: 840109

Recruiting

La Palma, California, United States, 90623

Newport Native MD, Inc. - Site Number: 840101

Recruiting

Newport Beach, California, United States, 92663

Pasadena Clinical Trials - Site Number: 840116

Recruiting

Pasadena, California, United States, 91101

Valiance Clinical Research (JPJ Research) - Site Number: 840135

Recruiting

Tarzana, California, United States, 91356

Clinical Research of California - Site Number: 840145

Recruiting

Walnut Creek, California, United States, 94598

Cornerstone Research Institute, LLC - Site Number: 840152

Recruiting

Altamonte Springs, Florida, United States, 32701

3SYNC Research - Boca Raton - Site Number: 840148

Recruiting

Boca Raton, Florida, United States, 33431

Meris Clinical Research - Site Number: 840167

Recruiting

Brandon, Florida, United States, 33511

Finlay Medical Research - Site Number: 840107

Recruiting

Greenacres City, Florida, United States, 33467

EMDA Clinical Research - Site Number: 840113

Recruiting

Miami, Florida, United States, 33126

Finlay Medical Research - Miami - Site Number: 840110

Recruiting

Miami, Florida, United States, 33126

Care Research Inc. - Site Number: 840103

Recruiting

Miami, Florida, United States, 33130

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

Recruiting

Miami, Florida, United States, 33142

MedOne Clinical Research - Site Number: 840122

Recruiting

Miami, Florida, United States, 33145

D&H National Research Centers INC - Site Number: 840128

Recruiting

Miami, Florida, United States, 33155

Research Institute Of South Florida - Site Number: 840149

Recruiting

Miami, Florida, United States, 33173

Valencia Medical & Research Center, Corp - Site Number: 840153

Recruiting

Miami, Florida, United States, 33174

Correa Research Center, Inc. - Site Number: 840141

Recruiting

Miami, Florida, United States, 33186

Pro Care Research Center - Site Number: 840143

Recruiting

Miami Gardens, Florida, United States, 33014

3SYNC Research - Miami Lakes - Site Number: 840146

Recruiting

Miami Lakes, Florida, United States, 33014

Deluxe Health Center - Site Number: 840117

Recruiting

Miami Lakes, Florida, United States, 33014

MedQuest Translation Sciences, LLC - Site Number: 840162

Recruiting

Miami Lakes, Florida, United States, 33016

Biscayne Clinical Research - Site Number: 840157

Recruiting

North Miami Beach, Florida, United States, 33169

Edward Jenner Research Group, LLC - Site Number: 840169

Recruiting

Plantation, Florida, United States, 33317

Mark J. Pamer D.O., LLC - Site Number: 840121

Recruiting

Port Saint Lucie, Florida, United States, 34986

TBC Research Corp - Site Number: 840132

Recruiting

Tamarac, Florida, United States, 33321

Avita Clinical Research - Tampa - Site Number: 840125

Recruiting

Tampa, Florida, United States, 33613

Palm Beach Medical & Research Center, Inc. - Site Number: 840165

Recruiting

West Palm Beach, Florida, United States, 33409

The Allergy Center at Brookstone - Site Number: 840114

Recruiting

Columbus, Georgia, United States, 31904

Next Innovation Clinical Research - Chicago - Site Number: 840159

Recruiting

Chicago, Illinois, United States, 60616

Bluegrass Allergy Care - Lexington - Site Number:840112

Recruiting

Lexington, Kentucky, United States, 40509

Velocity Clinical Research - Rockville - Site Number: 840163

Recruiting

Rockville, Maryland, United States, 20854

Montana Medical Research - Site Number: 840137

Recruiting

Missoula, Montana, United States, 59808

Primary Clinical Research, LLC - Papillion - Site Number: 840168

Recruiting

Papillion, Nebraska, United States, 68046

MedCorps Asthma and Pulmonary Specialists LLC - Sewell - Site Number: 840136

Recruiting

Sewell, New Jersey, United States, 08080

Finger Lakes Medical Research, PLLC - Site Number: 840155

Recruiting

Cortland, New York, United States, 13045

Mid Hudson Medical Research, PLLC - Site Number: 840139

Recruiting

New Windsor, New York, United States, 12553

Icahn School of Medicine at Mount Sinai - Center for Advanced Medicine - Site Number: 840119

Recruiting

New York, New York, United States, 10029

Allergy Partners of Western North Carolina - Site Number: 840131

Recruiting

Asheville, North Carolina, United States, 28801

Clinical Research of Gastonia (CRG) - Site Number: 840160

Recruiting

Gastonia, North Carolina, United States, 28054-7489

NexGen Research - Site Number: 840154

Recruiting

Lima, Ohio, United States, 45801

Toledo Institute of Clinical Research Inc - Site Number: 840105

Recruiting

Toledo, Ohio, United States, 43617

Allergy and Clinical Immunology Associates - Site Number: 840127

Recruiting

Pittsburgh, Pennsylvania, United States, 15241

Clinical Research of Rock Hill - Site Number: 840115

Recruiting

Rock Hill, South Carolina, United States, 29732

Allergy Associates, PA dba Allergy, Asthma and Sinus Center - Site Number: 840144

Recruiting

Tennessee City, Tennessee, United States, 30909

Southwest Family Medicine Associates - Site Number: 840126

Recruiting

Dallas, Texas, United States, 75235

El Paso Pulmonary Association (EPPA) - West El Paso - Site Number: 840108

Recruiting

El Paso, Texas, United States, 79902

Lumi Research - Site Number: 840156

Recruiting

Houston, Texas, United States, 77090

Pioneer Research Solutions - Site Number: 840104

Recruiting

Houston, Texas, United States, 77099

Lumi Research - Hurst - Site Number: 840164

Recruiting

Hurst, Texas, United States, 76054

DM Clinical - Tomball - Site Number: 840130

Recruiting

Tomball, Texas, United States, 77081

Bellingham Asthma, Allergy & Immunology Clinic - Site Number: 840138

Recruiting

Bellingham, Washington, United States, 98225

Investigational Site Number: 124203

Recruiting

Calgary, Alberta, Canada, T3R 1W7

Investigational Site Number: 124201

Recruiting

Windsor, Ontario, Canada, N8X 2G1

More Information

Sponsor

Sanofi

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

Cross-Sectional
Multicenter
Inhaled Corticosteroids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-08-13.