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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Procedure: Investigational Procedures; Other: Procedure: Investigational Procedures

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended-Toll free for US & Canada; Phone Number: 6 800-633-1610; Email: Contact-US@sanofi.com

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Clinical Research of California - Site Number: 840145
  • Florida
    • Miami, Florida, United States, 33142
      • Recruiting
      • L&A Morales Healthcare, Inc - Site Number: 840102
  • Montana
    • Missoula, Montana, United States, 59808
      • Recruiting
      • Montana Medical Research - Site Number: 840137
  • Texas
    • Houston, Texas, United States, 77099
      • Recruiting
      • Pioneer Research Solutions - Site Number: 840104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.; Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
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	Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.; Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Part-2: A2- Controlled Asthma Cohort; Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (<)1.5	Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.; Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Part-2: B1- Type-2 (T2) High Asthma Cohort; Participants receiving SoC with elevated T2 biomarkers	Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.; Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Part-2: B2- Type-2 Low Asthma Cohort; Participants receiving SoC with low T2 biomarkers	Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.; Other: Procedure: Investigational Procedures; Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Part 1: At baseline
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)	Part 1: At baseline
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).	Part 1: At baseline
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.	Part 1: At baseline
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.	Part 2: At Weeks 52 and 104
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.	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	Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration.	Part-2: At Weeks 52 and 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Demographics and Clinical Characteristics		Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Disease Burden, Health Status, Treatment Experiences		Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Medication Use		Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Lifestyle and Environmental Influences		Part 1: From 12 months prior to study enrollment
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.	Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Inhaled and Systemic Corticosteroid Use		Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Healthcare Resource Utilization (HCRU)		Part 1: From 12 months prior to study enrollment
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.	Part 1: From 12 months prior to study enrollment
Part 2: Descriptive Characterization Including Sociodemographics and Disease Characteristics and Treatment History.		Part 2: At baseline
Part 2: Annualized Exacerbation Rates at Week 52 and 104		Part 2: At Weeks 52 and 104
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).	Part 2: From baseline to week 52 and week 104
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.	Part 2: From baseline to week 52 and week 104
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.	Part 2: From baseline to week 52 and week 104
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.	Part 2: At Weeks 52 and 104
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.	Part 2: At Weeks 52 and 104
Part 2: Number of Participants Analyzed for Changes in Inhaled and Systemic Corticosteroid Burden		Part 2: From baseline up to week 104
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.	Part 2: From baseline to week 52 and week 104
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.	Part 2: At Weeks 52 and 104
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.	Part 2: From baseline to week 52 and week 104
Part 2: Changes in Biomarker Level		Part 2: At Weeks 52 and 104

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Syneos Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): April 4, 2029
• Study Completion (Estimated): April 4, 2029

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cross-Sectional; Multicenter; Inhaled Corticosteroids
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: PIR21191; 2025-524916-13-00 (Ctis); U1111-1336-5183 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No