A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Study on Asthma Characteristics and Outcomes in Routine Clinical Practice
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.
This study investigates asthma and its characteristics in individuals receiving routine clinical care. The purpose of this study is to explore various aspects of asthma, including sociodemographic and clinical features, treatment levels, and the impact on daily life.
The study focuses on understanding the burden of asthma and the quality of life of those affected. It evaluates factors like disease severity and health-related quality of life without detailing specific study methods or participant assignments.
- Who can participate: Participants aged 6 years and older with a physician's diagnosis of asthma for at least 12 months may qualify. Participants should be on existing asthma treatments, and those with certain health conditions or on specific medications are excluded.
- Study details: Participants will provide information about their asthma, including treatments and health impacts.
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