Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524916-13-00 | EU Trial (CTIS) Number | ||
| U1111-1336-5183 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Syneos Health | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
| |
| Part-2: A2- Controlled Asthma Cohort | Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (<)1.5 |
| |
| Part-2: B1- Type-2 (T2) High Asthma Cohort | Participants receiving SoC with elevated T2 biomarkers |
| |
| Part-2: B2- Type-2 Low Asthma Cohort | Participants receiving SoC with low T2 biomarkers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: Investigational Procedures | Other | Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration. |
| 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. |
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended-Toll free for US & Canada | Contact | 800-633-1610 | 6 | Contact-US@sanofi.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research of California - Site Number: 840145 | Recruiting | Walnut Creek | California | 94598 | United States | |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure: Investigational Procedures | Other | Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration. |
|
| 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 |
| 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 |
| L&A Morales Healthcare, Inc - Site Number: 840102 |
| Recruiting |
| Miami |
| Florida |
| 33142 |
| United States |
| Montana Medical Research - Site Number: 840137 | Recruiting | Missoula | Montana | 59808 | United States |
| Pioneer Research Solutions - Site Number: 840104 | Recruiting | Houston | Texas | 77099 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided