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

NCT07556159 · Sanofi
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Official title
A Hybrid Cross-sectional and Prospective Study to Assess Patient Characteristics, Disease Burden, Disease Control, Phenotypes, Endotypes, and Outcomes in a Real-world Setting in Patients With Asthma
About this study
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.
Eligibility 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
Enrollment target: 2500 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2026-04-01
Estimated completion: 2029-04-04
Last updated: 2026-09-08
Interventions
Other: Procedure: Investigational ProceduresOther: Procedure: Investigational Procedures
Primary outcomes
  • Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities (Part 1: At baseline)
  • Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma (Part 1: At baseline)
  • Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma (Part 1: At baseline)
Sponsor
Sanofi · industry
With: Syneos Health
Contacts & investigators
ContactTrial Transparency email recommended-Toll free for US & Canada · contact · Contact-US@sanofi.com · 800-633-1610
All locations (62)
Chandler Clinical Trials - Site Number: 840106Withdrawn
Chandler, Arizona, United States
Del Sol Research Management, LLC - Mesa - Site Number: 840123Recruiting
Mesa, Arizona, United States
Sun City Clinical Trials - Elite - Site Number: 840120Recruiting
Sun City, Arizona, United States
FOMAT - Huntington Asthma & Allergy Center - Site Number: 840158Recruiting
California City, California, United States
Imax Clinical Trials - Site Number: 840109Recruiting
La Palma, California, United States
Downtown LA Research - Site Number: 840161Recruiting
Los Angeles, California, United States
Newport Native MD, Inc. - Site Number: 840101Recruiting
Newport Beach, California, United States
Pasadena Clinical Trials - Site Number: 840116Recruiting
Pasadena, California, United States
Valiance Clinical Research (JPJ Research) - Site Number: 840135Withdrawn
Tarzana, California, United States
Clinical Research of California - Site Number: 840145Recruiting
Walnut Creek, California, United States
Cornerstone Research Institute, LLC - Site Number: 840152Recruiting
Altamonte Springs, Florida, United States
3SYNC Research - Boca Raton - Site Number: 840148Recruiting
Boca Raton, Florida, United States
Meris Clinical Research - Site Number: 840167Recruiting
Brandon, Florida, United States
Finlay Medical Research - Site Number: 840107Recruiting
Greenacres City, Florida, United States
EMDA Clinical Research - Site Number: 840113Recruiting
Miami, Florida, United States
Finlay Medical Research - Miami - Site Number: 840110Recruiting
Miami, Florida, United States
Care Research Inc. - Site Number: 840103Recruiting
Miami, Florida, United States
L&A Morales Healthcare, Inc - Site Number: 840102Recruiting
Miami, Florida, United States
MedOne Clinical Research - Site Number: 840122Recruiting
Miami, Florida, United States
D&H National Research Centers INC - Site Number: 840128Recruiting
Miami, Florida, United States
Research Institute Of South Florida - Site Number: 840149Recruiting
Miami, Florida, United States
Valencia Medical & Research Center, Corp - Site Number: 840153Recruiting
Miami, Florida, United States
Correa Research Center, Inc. - Site Number: 840141Recruiting
Miami, Florida, United States
Pro Care Research Center - Site Number: 840143Recruiting
Miami Gardens, Florida, United States
3SYNC Research - Miami Lakes - Site Number: 840146Recruiting
Miami Lakes, Florida, United States
Deluxe Health Center - Site Number: 840117Recruiting
Miami Lakes, Florida, United States
MedQuest Translation Sciences, LLC - Site Number: 840162Recruiting
Miami Lakes, Florida, United States
Biscayne Clinical Research - Site Number: 840157Recruiting
North Miami Beach, Florida, United States
CTMD Research, Inc - Site Number: 840147Recruiting
Palm Springs, Florida, United States
Edward Jenner Research Group, LLC - Site Number: 840169Recruiting
Plantation, Florida, United States
Mark J. Pamer D.O., LLC - Site Number: 840121Recruiting
Port Saint Lucie, Florida, United States
TBC Research Corp - Site Number: 840132Recruiting
Tamarac, Florida, United States
Avita Clinical Research - Tampa - Site Number: 840125Recruiting
Tampa, Florida, United States
Palm Beach Medical & Research Center, Inc. - Site Number: 840165Recruiting
West Palm Beach, Florida, United States
The Allergy Center at Brookstone - Site Number: 840114Recruiting
Columbus, Georgia, United States
Next Innovation Clinical Research - Chicago - Site Number: 840159Recruiting
Chicago, Illinois, United States
Bluegrass Allergy Care - Lexington - Site Number:840112Recruiting
Lexington, Kentucky, United States
Velocity Clinical Research - Rockville - Site Number: 840163Recruiting
Rockville, Maryland, United States
Montana Medical Research - Site Number: 840137Recruiting
Missoula, Montana, United States
Primary Clinical Research, LLC - Papillion - Site Number: 840168Recruiting
Papillion, Nebraska, United States
MedCorps Asthma and Pulmonary Specialists LLC - Sewell - Site Number: 840136Recruiting
Sewell, New Jersey, United States
Finger Lakes Medical Research, PLLC - Site Number: 840155Recruiting
Cortland, New York, United States
Mid Hudson Medical Research, PLLC - Site Number: 840139Recruiting
New Windsor, New York, United States
Icahn School of Medicine at Mount Sinai - Center for Advanced Medicine - Site Number: 840119Recruiting
New York, New York, United States
Allergy Partners of Western North Carolina - Site Number: 840131Recruiting
Asheville, North Carolina, United States
Clinical Research of Gastonia (CRG) - Site Number: 840160Recruiting
Gastonia, North Carolina, United States
NexGen Research - Site Number: 840154Recruiting
Lima, Ohio, United States
Toledo Institute of Clinical Research Inc - Site Number: 840105Recruiting
Toledo, Ohio, United States
Allergy and Clinical Immunology Associates - Site Number: 840127Recruiting
Pittsburgh, Pennsylvania, United States
Clinical Research of Rock Hill - Site Number: 840115Recruiting
Rock Hill, South Carolina, United States
Allergy Associates, PA dba Allergy, Asthma and Sinus Center - Site Number: 840144Recruiting
Tennessee City, Tennessee, United States
Southwest Family Medicine Associates - Site Number: 840126Recruiting
Dallas, Texas, United States
El Paso Pulmonary Association (EPPA) - West El Paso - Site Number: 840108Recruiting
El Paso, Texas, United States
Lumi Research - Site Number: 840156Recruiting
Houston, Texas, United States
Pioneer Research Solutions - Site Number: 840104Recruiting
Houston, Texas, United States
Lumi Research - Hurst - Site Number: 840164Recruiting
Hurst, Texas, United States
DM Clinical - Tomball - Site Number: 840130Recruiting
Tomball, Texas, United States
Bellingham Asthma, Allergy & Immunology Clinic - Site Number: 840138Recruiting
Bellingham, Washington, United States
Investigational Site Number: 124203Recruiting
Calgary, Alberta, Canada
Investigational Site Number: 124201Recruiting
Windsor, Ontario, Canada
Investigational Site Number: 392705Recruiting
Kitakyushu-Shi, Fukuoka, Japan
Investigational Site Number: 392702Recruiting
Takamatsu, Kagawa-ken, Japan