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

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Procedure: Investigational Procedures — OTHER
  Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.
• Procedure: Investigational Procedures — OTHER
  Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.

Study Details

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.

Key Dates

First listed

Apr 29, 2026

Start date

Apr 1, 2026

Status verified

Aug 2026

Primary completion

Apr 4, 2029

Completion

Apr 4, 2029

Study Design

Enrollment

2,500 participants (estimated)

Arms

• Arm: Part-1: Participants With Asthma
  Participants receiving treatment with low-, medium-, or high-dose inhaled corticosteroids (ICS) and/or biologic therapies as part of standard of care (SoC) for the management of asthma in routine clinical practice.
• Arm: Part-2: A1- Uncontrolled Asthma Cohort
  Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of greater than or equal to (\>=)1.5
• Arm: Part-2: A2- Controlled Asthma Cohort
  Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (\<)1.5
• Arm: Part-2: B1- Type-2 (T2) High Asthma Cohort
  Participants receiving SoC with elevated T2 biomarkers
• Arm: Part-2: B2- Type-2 Low Asthma Cohort
  Participants receiving SoC with low T2 biomarkers

Primary Outcome Measure

Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities [ Time Frame: Part 1: At baseline ]

Central Contacts

• Trial Transparency email recommended-Toll free for US & Canada
  800-633-1610
  [email protected]

Locations (56)

Find similar trials in Chandler, AZ

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