Health TrialsbyHealthPanel

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

ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorSanofi

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Enrollment into Part 1 is planned to achieve a balanced distribution of participants across participating regions, to the extent feasible. In addition, enrollment is intended to include pediatric participants, adolescents, and adults. Enrollment into Part 2 is planned to achieve a balanced distribution of participants across participating regions, to the extent feasible.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Procedure: Investigational Procedures

    Other intervention

    Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.

  • Procedure: Investigational Procedures

    Other intervention

    Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.

Treatment groups

2,500 Participants
are divided into 5 treatment groups
Group A: Part-1: Participants With Asthma1 intervention
Group B: Part-2: A1- Uncontrolled Asthma Cohort1 intervention
Group C: Part-2: A2- Controlled Asthma Cohort1 intervention
Group D: Part-2: B1- Type-2 (T2) High Asthma Cohort1 intervention
Group E: Part-2: B2- Type-2 Low Asthma Cohort1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities

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

Time frame
Part 1: At baseline
2

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

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)

Time frame
Part 1: At baseline
3

Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma

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).

Time frame
Part 1: At baseline
4

Part 1: Physician Global Assessment of Asthma Severity and Symptom Control

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.

Time frame
Part 1: At baseline

Secondary outcomes

1

Part 1: Physician-Reported Outcomes to Characterize Physician Perspectives

The treatment preferences for participant profiles, an assessment of perceived disease burden on participants, an evaluation of barriers to optimal treatment, and treatment adherence and persistence will be collected from the main treating physician.

Time frame
Part 1: From 12 months prior to study enrollment
2

Part 1: Number of Participants Characterised by Their Demographics and Clinical Characteristics

Time frame
Part 1: From 12 months prior to study enrollment
3

Part 1: Number of Participants Characterised by Their Disease Burden, Health Status, Treatment Experiences

Time frame
Part 1: From 12 months prior to study enrollment
4

Part 1: Number of Participants Characterised by Medication Use

Time frame
Part 1: From 12 months prior to study enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Syneos Health

Collaborator

Source ClinicalTrials.gov
Apply now