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

NCT07556159 | Recruiting

• 3 other identifiers: PIR211912025-524916-13-00U1111-1336-5183
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 4

Brief 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. 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

Keywords

Cross-Sectional; Multicenter; Inhaled Corticosteroids

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (21)

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

  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

Study Arms (5)

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

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

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

Part-2: B1- Type-2 (T2) High Asthma Cohort

Participants receiving SoC with elevated T2 biomarkers

Other: Procedure: Investigational Procedures

Part-2: B2- Type-2 Low Asthma Cohort

Participants receiving SoC with low T2 biomarkers

Other: Procedure: Investigational Procedures

Interventions

Procedure: Investigational Procedures OTHER

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

Part-1: Participants With Asthma

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Sanofi: lead
• Syneos Health: collaborator

Study Sites (4)

Clinical Research of California - Site Number: 840145

Walnut Creek, California, 94598, United States

RECRUITING

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

Miami, Florida, 33142, United States

RECRUITING

Montana Medical Research - Site Number: 840137

Missoula, Montana, 59808, United States

RECRUITING

Pioneer Research Solutions - Site Number: 840104

Houston, Texas, 77099, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended-Toll free for US & Canada

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 4, 2029
• Study Completion (Estimated): April 4, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)