A Study Evaluating Disease Characteristics and Outcomes in Participants With 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 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities

Time frame: Part 1: At baseline

Descriptive Statistical Analyses may include sociodemographic and clinical characteristics, comorbidities, exacerbation history, medication burden, biomarkers and lung function.

Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma

Time frame: Part 1: At baseline

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: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma

Time frame: Part 1: At baseline

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: Physician Global Assessment of Asthma Severity and Symptom Control

Time frame: Part 1: At baseline

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 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

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: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2

Time frame: Part 2: At Weeks 52 and 104

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: 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

Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.