An observational study in Asthma, sponsored by Sanofi. Recruiting at 83 sites in 6 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Sanofi · Observational
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Applicable for Part 1 participants:
Applicable for Part 2 participants:
A) Asthma control cohorts
Participants are excluded from the study if any of the following criteria apply (applicable for both Part 1 and Part 2 participants):
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of greater than or equal to (\>=)1.5
Other: Procedure: Investigational Procedures
Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (\<)1.5
Other: Procedure: Investigational Procedures
Participants receiving SoC with elevated T2 biomarkers
Other: Procedure: Investigational Procedures
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.
Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
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.
Time frame: 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)
Time frame: 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).
Time frame: 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.
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
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.
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
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.
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
Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration.
Time frame: Part-2: At Weeks 52 and 104
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.
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Demographics and Clinical Characteristics
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Disease Burden, Health Status, Treatment Experiences
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Medication Use
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Lifestyle and Environmental Influences
Time frame: 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.
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Inhaled and Systemic Corticosteroid Use
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Healthcare Resource Utilization (HCRU)
Time frame: 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.
Time frame: Part 1: From 12 months prior to study enrollment
Part 2: Descriptive Characterization Including Sociodemographics and Disease Characteristics and Treatment History.
Time frame: Part 2: At baseline
Part 2: Annualized Exacerbation Rates at Week 52 and 104
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Part 2: At Weeks 52 and 104
Part 2: Number of Participants Analyzed for Changes in Inhaled and Systemic Corticosteroid Burden
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Part 2: From baseline to week 52 and week 104
Part 2: Changes in Biomarker Level
Time frame: Part 2: At Weeks 52 and 104
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Plan to share: 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
Started Apr 2026 (actual). Primary completion is estimated for Apr 2029, 36 months after the start.
Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's planned 36 months is above that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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