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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at people with mild to severe asthma during their usual care. It studies their health, treatments, and how asthma affects daily life. Part 1 is for people age 6 and older, and Part 2 follows adults over time to see how their asthma changes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Part 1: Be age 6 or older when consent is signed.
  • Part 2: Be age 18 or older when consent is signed.
  • Both parts: Have had a doctor's diagnosis of asthma for at least 12 months.
  • Part 1: Use a low, medium, or high dose of an inhaled steroid and other asthma treatments matching guideline steps 2–5.
  • Part 2: Use a low or medium dose of an inhaled steroid and other asthma treatments matching guideline steps 2–4.
  • Both parts: You or your legal representative must agree to take part.
  • Part 2: Fit at least one study group based on an asthma control survey score or high or low levels of markers of type 2 inflammation.

Who can't join

  • Have COPD, a long-term lung disease that makes breathing hard, or heart failure.
  • Have moderate or severe problems with thinking or memory.
  • Have moderate or severe heart disease.
  • Take medicine that weakens the immune system for a long-term health condition.
  • Are in another clinical study now, or were in one in the past 3 months, whether or not it tested a treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 1. ACQ-5 \>= 1.5 2. ACQ-5 \< 1.5 (B) Type-2 biomarker cohorts 3. Elevated T2 biomarkers (B1: Type-2-high cohort) 4. 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.

Study sites (63)

AL

AZ

CA

FL

GA

IL

KY

MD

MI

MT

NC

  • Allergy Partners of Western North Carolina - Site Number: 840131 · Asheville, NC 28801More trials in Asheville
  • Clinical Research of Gastonia (CRG) - Site Number: 840160 · Gastonia, NC 28054-7489More trials in Gastonia
  • East Carolina University Physicians - Pulmonary and Critical Care Medicine - Site Number: 840142 · Greenville, NC 27834-2849More trials in Greenville

NE

NJ

  • MedCorps Asthma and Pulmonary Specialists LLC - Sewell - Site Number: 840136 · Sewell, NJ 08080More trials in Sewell

NY

OH

PA

SC

TN

TX

WA