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.
Study Type
OBSERVATIONAL
Enrollment
2,500
Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.
Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
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
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
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
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
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Chandler Clinical Trials - Site Number: 840106
Chandler, Arizona, United States
WITHDRAWNDel Sol Research Management, LLC - Mesa - Site Number: 840123
Mesa, Arizona, United States
ACTIVE_NOT_RECRUITINGSun City Clinical Trials - Elite - Site Number: 840120
Sun City, Arizona, United States
ACTIVE_NOT_RECRUITINGFOMAT - Huntington Asthma & Allergy Center - Site Number: 840158
California City, California, United States
ACTIVE_NOT_RECRUITINGImax Clinical Trials - Site Number: 840109
La Palma, California, United States
ACTIVE_NOT_RECRUITINGDowntown LA Research - Site Number: 840161
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGNewport Native MD, Inc. - Site Number: 840101
Newport Beach, California, United States
ACTIVE_NOT_RECRUITINGPasadena Clinical Trials - Site Number: 840116
Pasadena, California, United States
ACTIVE_NOT_RECRUITINGValiance Clinical Research (JPJ Research) - Site Number: 840135
Tarzana, California, United States
WITHDRAWNClinical Research of California - Site Number: 840145
Walnut Creek, California, United States
ACTIVE_NOT_RECRUITING...and 52 more locations
Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2
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.
Time frame: Part 2: At Weeks 52 and 104
Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2
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.
Time frame: Part 2: At Weeks 52 and 104
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
Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration.
Time frame: Part-2: At Weeks 52 and 104
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
Part 1: Number of Participants Characterised by Their Demographics and Clinical Characteristics
Time frame: Part 1: From 12 months prior to study enrollment
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
Part 1: Number of Participants Characterised by Medication Use
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Lifestyle and Environmental Influences
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Change From Baseline in Patient Global Impression of Severity (PGIS) Score
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.
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Inhaled and Systemic Corticosteroid Use
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Healthcare Resource Utilization (HCRU)
Time frame: Part 1: From 12 months prior to study enrollment
Part 1: Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score
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.
Time frame: Part 1: From 12 months prior to study enrollment
Part 2: Descriptive Characterization Including Sociodemographics and Disease Characteristics and Treatment History.
Time frame: Part 2: At baseline
Part 2: Annualized Exacerbation Rates at Week 52 and 104
Time frame: 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)
FEV1 will be measured in Liters. Change from baseline: mean of (value of observed FEV1 at treatment duration minus baseline value).
Time frame: 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
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.
Time frame: 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)
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Part 2: At Weeks 52 and 104
Part 2: Number of Participants Analyzed for Changes in Inhaled and Systemic Corticosteroid Burden
Time frame: Part 2: From baseline up to week 104
Part 2: Changes in Physician-reported HCRU (Hospitalizations, Outpatient and Emergency Visits)
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.
Time frame: Part 2: From baseline to week 52 and week 104
Part 2: Changes in Patient-Reported Outcomes to Characterize Disease Evolution
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.
Time frame: Part 2: At Weeks 52 and 104
Part 2: Changes in Participant Survey Response
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.
Time frame: Part 2: From baseline to week 52 and week 104
Part 2: Changes in Biomarker Level
Time frame: Part 2: At Weeks 52 and 104