A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Recruiting · NCT07556159 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
Procedure: Investigational Procedures
What this trial is about
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 take part
Age range
6 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
- 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)
- 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.
Where it is running
60 locations listed across 18 US states.
- Chandler Clinical Trials - Site Number: 840106 - Chandler, Arizona, United States
- Del Sol Research Management, LLC - Mesa - Site Number: 840123 - Mesa, Arizona, United States
- Sun City Clinical Trials - Elite - Site Number: 840120 - Sun City, Arizona, United States
- FOMAT - Huntington Asthma & Allergy Center - Site Number: 840158 - California City, California, United States
- Imax Clinical Trials - Site Number: 840109 - La Palma, California, United States
- Downtown LA Research - Site Number: 840161 - Los Angeles, California, United States
- Newport Native MD, Inc. - Site Number: 840101 - Newport Beach, California, United States
- Pasadena Clinical Trials - Site Number: 840116 - Pasadena, California, United States
- Valiance Clinical Research (JPJ Research) - Site Number: 840135 - Tarzana, California, United States
- Clinical Research of California - Site Number: 840145 - Walnut Creek, California, United States
- Cornerstone Research Institute, LLC - Site Number: 840152 - Altamonte Springs, Florida, United States
- 3SYNC Research - Boca Raton - Site Number: 840148 - Boca Raton, Florida, United States
- Meris Clinical Research - Site Number: 840167 - Brandon, Florida, United States
- Finlay Medical Research - Site Number: 840107 - Greenacres City, Florida, United States
- EMDA Clinical Research - Site Number: 840113 - Miami, Florida, United States
- Finlay Medical Research - Miami - Site Number: 840110 - Miami, Florida, United States
- Care Research Inc. - Site Number: 840103 - Miami, Florida, United States
- L&A Morales Healthcare, Inc - Site Number: 840102 - Miami, Florida, United States
- MedOne Clinical Research - Site Number: 840122 - Miami, Florida, United States
- D&H National Research Centers INC - Site Number: 840128 - Miami, Florida, United States
- Research Institute Of South Florida - Site Number: 840149 - Miami, Florida, United States
- Valencia Medical & Research Center, Corp - Site Number: 840153 - Miami, Florida, United States
- Correa Research Center, Inc. - Site Number: 840141 - Miami, Florida, United States
- Pro Care Research Center - Site Number: 840143 - Miami Gardens, Florida, United States
- 3SYNC Research - Miami Lakes - Site Number: 840146 - Miami Lakes, Florida, United States
- Deluxe Health Center - Site Number: 840117 - Miami Lakes, Florida, United States
- MedQuest Translation Sciences, LLC - Site Number: 840162 - Miami Lakes, Florida, United States
- Biscayne Clinical Research - Site Number: 840157 - North Miami Beach, Florida, United States
- CTMD Research, Inc - Site Number: 840147 - Palm Springs, Florida, United States
- Edward Jenner Research Group, LLC - Site Number: 840169 - Plantation, Florida, United States
- Mark J. Pamer D.O., LLC - Site Number: 840121 - Port Saint Lucie, Florida, United States
- TBC Research Corp - Site Number: 840132 - Tamarac, Florida, United States
- Avita Clinical Research - Tampa - Site Number: 840125 - Tampa, Florida, United States
- Palm Beach Medical & Research Center, Inc. - Site Number: 840165 - West Palm Beach, Florida, United States
- The Allergy Center at Brookstone - Site Number: 840114 - Columbus, Georgia, United States
- Next Innovation Clinical Research - Chicago - Site Number: 840159 - Chicago, Illinois, United States
- Bluegrass Allergy Care - Lexington - Site Number:840112 - Lexington, Kentucky, United States
- Velocity Clinical Research - Rockville - Site Number: 840163 - Rockville, Maryland, United States
- Montana Medical Research - Site Number: 840137 - Missoula, Montana, United States
- Primary Clinical Research, LLC - Papillion - Site Number: 840168 - Papillion, Nebraska, United States
- MedCorps Asthma and Pulmonary Specialists LLC - Sewell - Site Number: 840136 - Sewell, New Jersey, United States
- Finger Lakes Medical Research, PLLC - Site Number: 840155 - Cortland, New York, United States
- Mid Hudson Medical Research, PLLC - Site Number: 840139 - New Windsor, New York, United States
- Icahn School of Medicine at Mount Sinai - Center for Advanced Medicine - Site Number: 840119 - New York, New York, United States
- Allergy Partners of Western North Carolina - Site Number: 840131 - Asheville, North Carolina, United States
- Clinical Research of Gastonia (CRG) - Site Number: 840160 - Gastonia, North Carolina, United States
- NexGen Research - Site Number: 840154 - Lima, Ohio, United States
- Toledo Institute of Clinical Research Inc - Site Number: 840105 - Toledo, Ohio, United States
- Allergy and Clinical Immunology Associates - Site Number: 840127 - Pittsburgh, Pennsylvania, United States
- Clinical Research of Rock Hill - Site Number: 840115 - Rock Hill, South Carolina, United States
- Allergy Associates, PA dba Allergy, Asthma and Sinus Center - Site Number: 840144 - Tennessee City, Tennessee, United States
- Southwest Family Medicine Associates - Site Number: 840126 - Dallas, Texas, United States
- El Paso Pulmonary Association (EPPA) - West El Paso - Site Number: 840108 - El Paso, Texas, United States
- Lumi Research - Site Number: 840156 - Houston, Texas, United States
- Pioneer Research Solutions - Site Number: 840104 - Houston, Texas, United States
- Lumi Research - Hurst - Site Number: 840164 - Hurst, Texas, United States
- DM Clinical - Tomball - Site Number: 840130 - Tomball, Texas, United States
- Bellingham Asthma, Allergy & Immunology Clinic - Site Number: 840138 - Bellingham, Washington, United States
- Investigational Site Number: 124203 - Calgary, Alberta, Canada
- Investigational Site Number: 392705 - Kitakyushu-Shi, Fukuoka, Japan
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →