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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 2,500
- 试验地点
- 64
- 主要终点
- Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Part-2: B2- Type-2 Low Asthma Cohort
Participants receiving SoC with low T2 biomarkers
干预措施: Procedure: Investigational Procedures (Other)
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.
干预措施: Procedure: Investigational Procedures (Other)
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
干预措施: Procedure: Investigational Procedures (Other)
Part-2: A2- Controlled Asthma Cohort
Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (<)1.5
干预措施: Procedure: Investigational Procedures (Other)
Part-2: B1- Type-2 (T2) High Asthma Cohort
Participants receiving SoC with elevated T2 biomarkers
干预措施: Procedure: Investigational Procedures (Other)
结局指标
主要结局
Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities
时间窗: Part 1: At baseline
Descriptive Statistical Analyses may include sociodemographic and clinical characteristics, comorbidities, exacerbation history, medication burden, biomarkers and lung function.
Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma
时间窗: Part 1: At baseline
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)
Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma
时间窗: Part 1: At baseline
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).
Part 1: Physician Global Assessment of Asthma Severity and Symptom Control
时间窗: Part 1: At baseline
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.
Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2
时间窗: Part 2: At Weeks 52 and 104
Data on participant's asthma symptoms and control will be collected via the ACQ-5, 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 MCID.
Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2
时间窗: Part 2: At Weeks 52 and 104
Treatment utilization will include systemic corticosteroids (SCS), ICS, and short-acting beta agonists (SABA). Number of participants with various treatment utilization pattern will be assessed and reported.
Part 2: Descriptive Statistical Analysis of Difference in Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV₁) between Part 2 Cohorts B1 and Cohort B2
时间窗: Part-2: At Weeks 52 and 104
Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration.
次要结局
- Part 1: Number of Participants Characterised by Their Lifestyle and Environmental Influences(Part 1: From 12 months prior to study enrollment)
- Part 1: Physician-Reported Outcomes to Characterize Physician Perspectives(Part 1: From 12 months prior to study enrollment)
- Part 1: Number of Participants Characterised by Their Demographics and Clinical Characteristics(Part 1: From 12 months prior to study enrollment)
- Part 1: Number of Participants Characterised by Their Disease Burden, Health Status, Treatment Experiences(Part 1: From 12 months prior to study enrollment)
- Part 1: Number of Participants Characterised by Medication Use(Part 1: From 12 months prior to study enrollment)
- Part 1: Change From Baseline in Patient Global Impression of Severity (PGIS) Score(Part 1: From 12 months prior to study enrollment)
- Part 1: Number of Participants Characterised by Inhaled and Systemic Corticosteroid Use(Part 1: From 12 months prior to study enrollment)
- Part 1: Number of Participants Characterised by Healthcare Resource Utilization (HCRU)(Part 1: From 12 months prior to study enrollment)
- Part 1: Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score(Part 1: From 12 months prior to study enrollment)
- Part 2: Descriptive Characterization Including Sociodemographics and Disease Characteristics and Treatment History.(Part 2: At baseline)
- Part 2: Annualized Exacerbation Rates at Week 52 and 104(Part 2: At Weeks 52 and 104)
- Part 2: Changes From Baseline to Week 104 in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Part 2: From baseline to week 52 and week 104)
- Part 2: Number of Participants With Significant Changes in Asthma Treatment Patterns at Week 52 and Week 104(Part 2: From baseline to week 52 and week 104)
- Part 2: Changes in Physician Global Assessment of Asthma Severity, Symptom Control and Comorbidities (PhGIS)(Part 2: From baseline to week 52 and week 104)
- Part 2: Number of Participants With Comorbidities and Burden of Comorbidities Based on the Participant Survey Using the PGIS scale(Part 2: At Weeks 52 and 104)
- Part 2: Number of Participants With Comorbidities and Burden of Comorbidities Based on the Physician Survey Using the PhGIS Scale(Part 2: At Weeks 52 and 104)
- Part 2: Number of Participants Analyzed for Changes in Inhaled and Systemic Corticosteroid Burden(Part 2: From baseline up to week 104)
- Part 2: Changes in Physician-reported HCRU (Hospitalizations, Outpatient and Emergency Visits)(Part 2: From baseline to week 52 and week 104)
- Part 2: Changes in Patient-Reported Outcomes to Characterize Disease Evolution(Part 2: At Weeks 52 and 104)
- Part 2: Changes in Participant Survey Response(Part 2: From baseline to week 52 and week 104)
- Part 2: Changes in Biomarker Level(Part 2: At Weeks 52 and 104)