A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Study of Asthma Characteristics and Health Outcomes in Routine Care
Study 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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Asthma
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Age: 6 years or above
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Gender: All
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.
The purpose of this research study is to describe the characteristics and health outcomes of people with asthma across different levels of disease severity. This includes looking at things like background and clinical features, current treatments, disease burden, biomarkers (measurable signs in the body), and quality of life.
Participants will take part in one or both parts of the study. One part collects information at a single point in time, and another part follows some participants over time to see how asthma changes.
Who can participate:
People with asthma may be able to participate if they:
- Are age 6 or older (for the first part of the study), or age 18 or older (for the follow-up part)
- Have had an asthma diagnosis from a doctor for at least one year
- Are already being treated with inhaled corticosteroids (a common type of asthma controller medicine) and other asthma treatments (the specific treatment steps differ by study part)
- For the follow-up part only, fit into at least one group based on asthma control or certain “type 2” biomarker levels
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