AzTrials
AzTrials

AsthmaAIRITYNCT07556159

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

An observational study of Asthma, run by Sanofi at 83 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Asthma
What is being tested?
Procedure: Investigational Procedures
How many people
2,500 participants
Where
83 sitesin 6 countries
Study dates
1 Apr 2026to 4 Apr 2029
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Enrollment into Part 1 is planned to achieve a balanced distribution of participants across participating regions, to the extent feasible. In addition, enrollment is intended to include pediatric participants, adolescents, and adults. Enrollment into Part 2 is planned to achieve a balanced distribution of participants across participating regions, to the extent feasible.

Who may be able to join

  • 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:
Show all 23Show fewer
  • 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:
  • 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.

Who cannot join

None listed.

Trial locations and contacts

83 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended-Toll free for US & Canada contact

800-633-1610 ext. 6

Contact-US@sanofi.com

83 sites in 6 countries

United States63 sites, 5 recruiting

  • Cornerstone Research Institute, LLC - Site Number: 840152

    Altamonte Springs, Florida, 32701

    Active, not recruiting

  • University of Michigan - Ann Arbor - Site Number: 840140

    Ann Arbor, Michigan, 48109

    Recruiting

  • Allergy Partners of Western North Carolina - Site Number: 840131

    Asheville, North Carolina, 28801

    Active, not recruiting

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

    Bellingham, Washington, 98225

    Active, not recruiting

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

    Bessemer, Alabama, 35022

    Recruiting

  • 3SYNC Research - Boca Raton - Site Number: 840148

    Boca Raton, Florida, 33431

    Active, not recruiting

  • Meris Clinical Research - Site Number: 840167

    Brandon, Florida, 33511

    Active, not recruiting

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

    California City, California, 91107

    Active, not recruiting

  • Chandler Clinical Trials - Site Number: 840106

    Chandler, Arizona, 85224

    Withdrawn

  • Next Innovation Clinical Research - Chicago - Site Number: 840159

    Chicago, Illinois, 60616

    Active, not recruiting

  • Columbia Medical Practice - Site Number: 840172

    Columbia, Maryland, 21045

    Recruiting

  • The Allergy Center at Brookstone - Site Number: 840114

    Columbus, Georgia, 31904

    Active, not recruiting

  • Finger Lakes Medical Research, PLLC - Site Number: 840155

    Cortland, New York, 13045

    Active, not recruiting

  • Southwest Family Medicine Associates - Site Number: 840126

    Dallas, Texas, 75235

    Active, not recruiting

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

    El Paso, Texas, 79902

    Active, not recruiting

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

    Gastonia, North Carolina, 28054-7489

    Active, not recruiting

  • Finlay Medical Research - Site Number: 840107

    Greenacres City, Florida, 33467

    Active, not recruiting

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

    Greenville, North Carolina, 27834-2849

    Recruiting

  • Lumi Research - Site Number: 840156

    Houston, Texas, 77090

    Active, not recruiting

  • Pioneer Research Solutions - Site Number: 840104

    Houston, Texas, 77099

    Active, not recruiting

  • Lumi Research - Hurst - Site Number: 840164

    Hurst, Texas, 76054

    Active, not recruiting

  • Imax Clinical Trials - Site Number: 840109

    La Palma, California, 90623

    Active, not recruiting

  • Bluegrass Allergy Care - Lexington - Site Number:840112

    Lexington, Kentucky, 40509

    Active, not recruiting

  • NexGen Research - Site Number: 840154

    Lima, Ohio, 45801

    Active, not recruiting

  • Downtown LA Research - Site Number: 840161

    Los Angeles, California, 90017

    Active, not recruiting

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

    Mesa, Arizona, 85206

    Active, not recruiting

  • EMDA Clinical Research - Site Number: 840113

    Miami, Florida, 33126

    Active, not recruiting

  • Finlay Medical Research - Miami - Site Number: 840110

    Miami, Florida, 33126

    Active, not recruiting

  • Care Research Inc. - Site Number: 840103

    Miami, Florida, 33130

    Active, not recruiting

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

    Miami, Florida, 33142

    Active, not recruiting

  • MedOne Clinical Research - Site Number: 840122

    Miami, Florida, 33145

    Active, not recruiting

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

    Miami, Florida, 33155

    Active, not recruiting

  • Research Institute Of South Florida - Site Number: 840149

    Miami, Florida, 33173

    Active, not recruiting

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

    Miami, Florida, 33174

    Active, not recruiting

  • Correa Research Center, Inc. - Site Number: 840141

    Miami, Florida, 33186

    Active, not recruiting

  • Pro Care Research Center - Site Number: 840143

    Miami Gardens, Florida, 33014

    Active, not recruiting

  • 3SYNC Research - Miami Lakes - Site Number: 840146

    Miami Lakes, Florida, 33014

    Active, not recruiting

  • Deluxe Health Center - Site Number: 840117

    Miami Lakes, Florida, 33014

    Active, not recruiting

  • MedQuest Translation Sciences, LLC - Site Number: 840162

    Miami Lakes, Florida, 33016

    Active, not recruiting

  • Montana Medical Research - Site Number: 840137

    Missoula, Montana, 59808

    Active, not recruiting

  • Mid Hudson Medical Research, PLLC - Site Number: 840139

    New Windsor, New York, 12553

    Active, not recruiting

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

    New York, New York, 10029

    Active, not recruiting

  • Newport Native MD, Inc. - Site Number: 840101

    Newport Beach, California, 92663

    Active, not recruiting

  • Biscayne Clinical Research - Site Number: 840157

    North Miami Beach, Florida, 33169

    Active, not recruiting

  • CTMD Research, Inc - Site Number: 840147

    Palm Springs, Florida, 33406

    Active, not recruiting

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

    Papillion, Nebraska, 68046

    Active, not recruiting

  • Pasadena Clinical Trials - Site Number: 840116

    Pasadena, California, 91101

    Active, not recruiting

  • Allergy and Clinical Immunology Associates - Site Number: 840127

    Pittsburgh, Pennsylvania, 15241

    Active, not recruiting

  • Edward Jenner Research Group, LLC - Site Number: 840169

    Plantation, Florida, 33317

    Active, not recruiting

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

    Port Saint Lucie, Florida, 34986

    Active, not recruiting

  • Clinical Research of Rock Hill - Site Number: 840115

    Rock Hill, South Carolina, 29732

    Active, not recruiting

  • Velocity Clinical Research - Rockville - Site Number: 840163

    Rockville, Maryland, 20854

    Active, not recruiting

  • Orso Health - Scottsdale - Site Number: 840133

    Scottsdale, Arizona, 85254

    Recruiting

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

    Sewell, New Jersey, 08080

    Active, not recruiting

  • Sun City Clinical Trials - Elite - Site Number: 840120

    Sun City, Arizona, 85351

    Active, not recruiting

  • TBC Research Corp - Site Number: 840132

    Tamarac, Florida, 33321

    Active, not recruiting

  • Avita Clinical Research - Tampa - Site Number: 840125

    Tampa, Florida, 33613

    Active, not recruiting

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

    Tarzana, California, 91356

    Withdrawn

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

    Tennessee City, Tennessee, 30909

    Active, not recruiting

  • Toledo Institute of Clinical Research Inc - Site Number: 840105

    Toledo, Ohio, 43617

    Active, not recruiting

  • DM Clinical - Tomball - Site Number: 840130

    Tomball, Texas, 77081

    Active, not recruiting

  • Clinical Research of California - Site Number: 840145

    Walnut Creek, California, 94598

    Active, not recruiting

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

    West Palm Beach, Florida, 33409

    Active, not recruiting

Other trials in United States

France6 sites, 6 recruiting

  • Investigational Site Number: 250616

    Argenteuil, Île-de-France Region, 95100

    Recruiting

  • Investigational Site Number: 250603

    Brest, Brittany Region, 29200

    Recruiting

  • Investigational Site Number: 250609

    Créteil, Île-de-France Region, 94010

    Recruiting

  • Investigational Site Number: 250613

    La Roche-sur-Yon, Pays de la Loire Region, 85000

    Recruiting

  • Investigational Site Number: 250612

    Lunel, Occitanie, 34400

    Recruiting

  • Investigational Site Number: 250607

    Toulouse, Occitanie, 31059

    Recruiting

Other trials in France

Japan6 sites, 6 recruiting

  • Investigational Site Number: 392710

    Bunkyo-ku, Tokyo, 113-8431

    Recruiting

  • Investigational Site Number: 392705

    Kitakyushu-Shi, Fukuoka, 802-0083

    Recruiting

  • Investigational Site Number: 392707

    Niigata

    Recruiting

  • Investigational Site Number: 392711

    Saga, Saga-ken, 849-8501

    Recruiting

  • Investigational Site Number: 392709

    tabashi City, Tokyo, 173-8610

    Recruiting

  • Investigational Site Number: 392702

    Takamatsu, Kagawa-ken, 761-8073

    Recruiting

Other trials in Japan

Germany4 sites, 4 recruiting

  • Investigational Site Number: 276505

    Bonn, North Rhine-Westphalia, 53119

    Recruiting

  • Investigational Site Number: 276501

    Hohenstein-Ernstthal, Saxony, 09337

    Recruiting

  • Investigational Site Number: 276503

    München, Bayern (Bavaria), 85039

    Recruiting

  • Investigational Site Number: 276502

    Schleswig, Schleswig-Holstein, 24837

    Recruiting

Other trials in Germany

Canada3 sites, 3 recruiting

  • Investigational Site Number: 124203

    Calgary, Alberta, T3R 1W7

    Recruiting

  • Investigational Site Number: 124204

    Trois-Rivières, Quebec, G8T7A1

    Recruiting

  • Investigational Site Number: 124201

    Windsor, Ontario, N8X 2G1

    Recruiting

Other trials in Canada

Spain1 site, 1 recruiting

  • Investigational Site Number: 724408

    Madrid, 28034

    Recruiting

Other trials in Spain

About this study

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

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
Being tested
Procedure: Investigational Procedures
Keywords
Cross-Sectional, Multicenter, Inhaled Corticosteroids
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procedure: Investigational ProceduresOther

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

  • Procedure: Investigational ProceduresOther

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

Study groups in NCT07556159
Study groupRoleWhat they receive
Part-1: Participants With AsthmaParticipants 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.
Receives: Other: Procedure: Investigational Procedures
Part-2: A1- Uncontrolled Asthma CohortParticipants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of greater than or equal to (>=)1.5
Receives: Other: Procedure: Investigational Procedures
Part-2: A2- Controlled Asthma CohortParticipants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (<)1.5
Receives: Other: Procedure: Investigational Procedures
Part-2: B1- Type-2 (T2) High Asthma CohortParticipants receiving SoC with elevated T2 biomarkers
Receives: Other: Procedure: Investigational Procedures
Part-2: B2- Type-2 Low Asthma CohortParticipants receiving SoC with low T2 biomarkers
Receives: Other: Procedure: Investigational Procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Descriptive Statistical Analyses may include sociodemographic and clinical characteristics, comorbidities, exacerbation history, medication burden, biomarkers and lung function.

    Measured: Part 1: At baseline

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

    ACQ-5 is a 5-question survey. The five ACQ-5 questions are scored on a 6-point scale (0 = good control, 6 = poor control), and the overall score is the mean of the five responses. Participant's scores are then classified into three prescribed groups as having well-controlled asthma (score ≤ 0.75); partially controlled asthma (score 0.75-1.5), or not well controlled asthma (score >1.5). A change in ACQ-5 score of 0.5 is considered the minimal clinically important difference (MCID)

    Measured: Part 1: At baseline

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

    The Asthma Quality of Life Questionnaire (AQLQ) includes 32 items, The mini-AQLQ is a reduced version of the AQLQ which includes 15 items. The questions correspond to 4 dimensions of health: symptoms (5 items), limitation of usual activities (4 items), emotional function (3 items) and environmental stimuli (3 items). The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability. Higher scores indicating better quality of life (less impairment) and lower scores indicating worse quality of life (greater impairment).

    Measured: Part 1: At baseline

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

    Asthma severity, asthma control, and comorbidity will be assessed using three global impression of severity items: Physician Global Impression of Severity (PhGIS) - asthma severity. PhGIS - asthma control, and PhGIS - comorbidity.

    Measured: Part 1: At baseline

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

    Data on participant's asthma symptoms and control will be collected via the ACQ-5, 5-question survey. The five ACQ-5 questions are scored on a 6-point scale (0 = good control, 6 = poor control), and the overall score is the mean of the five responses. Participant's scores are then classified into three prescribed groups as having well-controlled asthma (score <=0.75); partially controlled asthma (score 0.75-1.5), or not well controlled asthma (score >1.5). A change in ACQ-5 score of 0.5 is considered the MCID.

    Measured: Part 2: At Weeks 52 and 104

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

    Treatment utilization will include systemic corticosteroids (SCS), ICS, and short-acting beta agonists (SABA). Number of participants with various treatment utilization pattern will be assessed and reported.

    Measured: Part 2: At Weeks 52 and 104

  7. 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

    Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration.

    Measured: Part-2: At Weeks 52 and 104

Secondary outcomes (21)

  1. Part 1: Physician-Reported Outcomes to Characterize Physician Perspectives

    The treatment preferences for participant profiles, an assessment of perceived disease burden on participants, an evaluation of barriers to optimal treatment, and treatment adherence and persistence will be collected from the main treating physician.

    Measured: Part 1: From 12 months prior to study enrollment

  2. Part 1: Number of Participants Characterised by Their Demographics and Clinical Characteristics

    Measured: Part 1: From 12 months prior to study enrollment

  3. Part 1: Number of Participants Characterised by Their Disease Burden, Health Status, Treatment Experiences

    Measured: Part 1: From 12 months prior to study enrollment

  4. Part 1: Number of Participants Characterised by Medication Use

    Measured: Part 1: From 12 months prior to study enrollment

  5. Part 1: Number of Participants Characterised by Their Lifestyle and Environmental Influences

    Measured: Part 1: From 12 months prior to study enrollment

  6. Part 1: Change From Baseline in Patient Global Impression of Severity (PGIS) Score

    The PGIS is a single question asking the participant to rate their severity and symptom control. The PGIS is a 5-point ordinal scale ranging from 1 (No symptoms) to 5 (Very severe symptoms). Higher scores indicate greater symptom severity.

    Measured: Part 1: From 12 months prior to study enrollment

  7. Part 1: Number of Participants Characterised by Inhaled and Systemic Corticosteroid Use

    Measured: Part 1: From 12 months prior to study enrollment

  8. Part 1: Number of Participants Characterised by Healthcare Resource Utilization (HCRU)

    Measured: Part 1: From 12 months prior to study enrollment

  9. Part 1: Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score

    The WPAI-Asthma is an Asthma-specific, patient-reported measure of work absenteeism, work presenteeism (reduced productivity while working due to illness), total work productivity loss (absenteeism plus presenteeism), and overall activity impairment over the prior 7 days. The WPAI-Asthma questionnaire score represents the percentage of impairment, from 0 to 100%. Higher scores represent greater impairment and less productivity.

    Measured: Part 1: From 12 months prior to study enrollment

  10. Part 2: Descriptive Characterization Including Sociodemographics and Disease Characteristics and Treatment History.

    Measured: Part 2: At baseline

  11. Part 2: Annualized Exacerbation Rates at Week 52 and 104

    Measured: Part 2: At Weeks 52 and 104

  12. Part 2: Changes From Baseline to Week 104 in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    FEV1 will be measured in Liters. Change from baseline: mean of (value of observed FEV1 at treatment duration minus baseline value).

    Measured: Part 2: From baseline to week 52 and week 104

  13. Part 2: Number of Participants With Significant Changes in Asthma Treatment Patterns at Week 52 and Week 104

    Changes in treatment patterns including use of SCS, ICS, other asthma therapies, and rescue medication. Treatment escalation (for example [e.g.], ICS dose changes, addition of asthma therapies, or biologic prescription), treatment adherence, and treatment persistence will be assessed from baseline to Week 52 and Week 104 in participants with Asthma.

    Measured: Part 2: From baseline to week 52 and week 104

  14. Part 2: Changes in Physician Global Assessment of Asthma Severity, Symptom Control and Comorbidities (PhGIS)

    Asthma severity, asthma control, and comorbidity will be assessed using three global impression of severity items: PhGIS - asthma severity. PhGIS - asthma control, and PhGIS - comorbidity.

    Measured: Part 2: From baseline to week 52 and week 104

  15. Part 2: Number of Participants With Comorbidities and Burden of Comorbidities Based on the Participant Survey Using the PGIS scale

    The PGIS is a single question asking the participant to rate their severity and symptom control. The PGIS is a 5-point ordinal scale ranging from 1 (No symptoms) to 5 (Very severe symptoms). Higher scores indicate greater symptom severity.

    Measured: Part 2: At Weeks 52 and 104

  16. Part 2: Number of Participants With Comorbidities and Burden of Comorbidities Based on the Physician Survey Using the PhGIS Scale

    Asthma severity, asthma control, and comorbidity will be assessed using three global impression of severity items: PhGIS - asthma severity. PhGIS - asthma control, and PhGIS - comorbidity.

    Measured: Part 2: At Weeks 52 and 104

  17. Part 2: Number of Participants Analyzed for Changes in Inhaled and Systemic Corticosteroid Burden

    Measured: Part 2: From baseline up to week 104

  18. Part 2: Changes in Physician-reported HCRU (Hospitalizations, Outpatient and Emergency Visits)

    Data about HCRU associated with medical encounters will be collected by physicians from medical records. The data collected will include setting, department, type of specialist, the reasons and duration of hospitalizations, outpatient and emergency room (ER) visits.

    Measured: Part 2: From baseline to week 52 and week 104

  19. Part 2: Changes in Patient-Reported Outcomes to Characterize Disease Evolution

    PROs used will include but not limited to ACQ-5, mini-AQLQ. ACQ-5 questions are scored on a 6-point scale (0 = good control, 6 = poor control), Mean of the five responses is the overall score. Scores are then classified into three groups as having well-controlled asthma (score <= 0.75); partially controlled asthma (score 0.75-1.5), or not well controlled asthma (score >1.5). AQLQ includes 32 items, The mini-AQLQ is a reduced version of the AQLQ which includes 15 items. The questions correspond to 4 dimensions of health: symptoms (5 items), limitation of usual activities (4 items), emotional function (3 items) and environmental stimuli (3 items). The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability.

    Measured: Part 2: At Weeks 52 and 104

  20. Part 2: Changes in Participant Survey Response

    Participant survey collecting demographics, clinical characteristics, disease burden, health status, treatment experiences, medication use and burden, work and school impacts, lifestyle and environmental influences, impacts on daily life, PGIS for each comorbidity and burden of comorbidities, inhaled and systemic corticosteroid burden (frequency of use, routes of administration, treatment satisfaction), and HCRU office visits, hospitalizations, outpatient and emergency visits will be collected from medical records.

    Measured: Part 2: From baseline to week 52 and week 104

  21. Part 2: Changes in Biomarker Level

    Measured: Part 2: At Weeks 52 and 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start1 Apr 2026
  3. Primary completion4 Apr 2029 (estimated)
  4. Study completion4 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07556159
Sponsor's protocol ID
PIR21191
Other IDs
2025-524916-13-00, U1111-1336-5183, 2025
Acronym
AIRITY
Status last verified
Nov 2026
First submitted
31 Mar 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Sanofi at 83 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, France, Japan, Germany, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended-Toll free for US & Canada (800-633-1610 ext. 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities (time frame: Part 1: At baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07556159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in