Asthma
Conditions
Keywords
Cross-Sectional, Multicenter, Inhaled Corticosteroids
Brief summary
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.
Interventions
OTHERProcedure: Investigational Procedures
Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.
Sponsors
Sanofi
Syneos Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Physician Global Assessment of Asthma Severity and Symptom Control | 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 | 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 | 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 | 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. |
| Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants Characterised by Medication Use | 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 | The WPAI-Asthma is an Asthma-specific, patient-reported measure of work absenteeism, work presenteeism (reduced productivity while working due to illness), total work productivity loss (absenteeism plus presenteeism), and overall activity impairment over the prior 7 days. The WPAI-Asthma questionnaire score represents the percentage of impairment, from 0 to 100%. Higher scores represent greater impairment and less productivity. |
| 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 | FEV1 will be measured in Liters. Change from baseline: mean of (value of observed FEV1 at treatment duration minus baseline value). |
| 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 | Changes in treatment patterns including use of SCS, ICS, other asthma therapies, and rescue medication. Treatment escalation (for example \[e.g.\], ICS dose changes, addition of asthma therapies, or biologic prescription), treatment adherence, and treatment persistence will be assessed from baseline to Week 52 and Week 104 in participants with Asthma. |
| 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 | Asthma severity, asthma control, and comorbidity will be assessed using three global impression of severity items: PhGIS - asthma severity. PhGIS - asthma control, and PhGIS - comorbidity. |
| 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 | The PGIS is a single question asking the participant to rate their severity and symptom control. The PGIS is a 5-point ordinal scale ranging from 1 (No symptoms) to 5 (Very severe symptoms). Higher scores indicate greater symptom severity. |
| 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 | Asthma severity, asthma control, and comorbidity will be assessed using three global impression of severity items: PhGIS - asthma severity. PhGIS - asthma control, and PhGIS - comorbidity. |
| 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 | Data about HCRU associated with medical encounters will be collected by physicians from medical records. The data collected will include setting, department, type of specialist, the reasons and duration of hospitalizations, outpatient and emergency room (ER) visits. |
| Part 2: Changes in Patient-Reported Outcomes to Characterize Disease Evolution | Part 2: At Weeks 52 and 104 | PROs used will include but not limited to ACQ-5, mini-AQLQ. ACQ-5 questions are scored on a 6-point scale (0 = good control, 6 = poor control), Mean of the five responses is the overall score. Scores are then classified into three 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). 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. |
| Part 2: Changes in Participant Survey Response | Part 2: From baseline to week 52 and week 104 | Participant survey collecting demographics, clinical characteristics, disease burden, health status, treatment experiences, medication use and burden, work and school impacts, lifestyle and environmental influences, impacts on daily life, PGIS for each comorbidity and burden of comorbidities, inhaled and systemic corticosteroid burden (frequency of use, routes of administration, treatment satisfaction), and HCRU office visits, hospitalizations, outpatient and emergency visits will be collected from medical records. |
| Part 1: Change From Baseline in Patient Global Impression of Severity (PGIS) Score | Part 1: From 12 months prior to study enrollment | The PGIS is a single question asking the participant to rate their severity and symptom control. The PGIS is a 5-point ordinal scale ranging from 1 (No symptoms) to 5 (Very severe symptoms). Higher scores indicate greater symptom severity. |
| Part 2: Changes in Biomarker Level | Part 2: At Weeks 52 and 104 | — |
| Part 1: Number of Participants Characterised by Their Lifestyle and Environmental Influences | 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: Physician-Reported Outcomes to Characterize Physician Perspectives | Part 1: From 12 months prior to study enrollment | 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. |
| 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 | — |
Countries
Canada, Japan, United States
Contacts
CONTACTTrial Transparency email recommended-Toll free for US & Canada
Outcome results
None listed