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

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities [Time frame: Part 1: At baseline]
• Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma [Time frame: Part 1: At baseline]
• Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma [Time frame: Part 1: At baseline]
• Part 1: Physician Global Assessment of Asthma Severity and Symptom Control [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 [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 [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 [Time frame: Part-2: At Weeks 52 and 104]

Secondary outcome measures (12)

• Part 1: Physician-Reported Outcomes to Characterize Physician Perspectives [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 [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 [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) [Time frame: Part 2: From baseline to week 52 and week 104]

Eligibility criteria

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

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 51 centers

• Chandler Clinical Trials - Site Number: 840106 — Chandler
• Del Sol Research Management, LLC - Mesa - Site Number: 840123 — Mesa
• Sun City Clinical Trials - Elite - Site Number: 840120 — Sun City
• FOMAT - Huntington Asthma & Allergy Center - Site Number: 840158 — California City
• Imax Clinical Trials - Site Number: 840109 — La Palma
• Newport Native MD, Inc. - Site Number: 840101 — Newport Beach
• Pasadena Clinical Trials - Site Number: 840116 — Pasadena
• Valiance Clinical Research (JPJ Research) - Site Number: 840135 — Tarzana
• … and 43 more centers

Canada · 2 centers

• Investigational Site Number: 124203 — Calgary
• Investigational Site Number: 124201 — Windsor

Japan · 1 center

• Investigational Site Number: 392702 — Takamatsu

Identifiers

NCT: NCT07556159 · PIR21191 · 2025-524916-13-00 · U1111-1336-5183

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗