Une étude évaluant les caractéristiques de la maladie et les résultats chez les participants souffrant d'asthme dans la pratique clinique de routine (AIRITY)
Une étude hybride transversale et prospective visant à évaluer les caractéristiques des patients, le fardeau de la maladie, le contrôle de la maladie, les phénotypes, les endotypes et les résultats dans un contexte réel chez les patients souffrant d'asthme
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Trial Transparency email recommended-Toll free for US & Canada
- Numéro de téléphone: 6 800-633-1610
- E-mail: Contact-US@sanofi.com
Lieux d'étude
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Bayern (Bavaria)
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München, Bayern (Bavaria), Allemagne, 85039
- Recrutement
- Investigational Site Number: 276503
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Allemagne, 53119
- Recrutement
- Investigational Site Number: 276505
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Saxony
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Hohenstein-Ernstthal, Saxony, Allemagne, 09337
- Recrutement
- Investigational Site Number: 276501
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Schleswig-Holstein
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Schleswig, Schleswig-Holstein, Allemagne, 24837
- Recrutement
- Investigational Site Number: 276502
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Alberta
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Calgary, Alberta, Canada, T3R 1W7
- Recrutement
- Investigational Site Number: 124203
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Ontario
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Windsor, Ontario, Canada, N8X 2G1
- Recrutement
- Investigational Site Number: 124201
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Quebec
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Trois-Rivières, Quebec, Canada, G8T7A1
- Recrutement
- Investigational Site Number: 124204
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Madrid, Espagne, 28034
- Recrutement
- Investigational Site Number: 724408
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Brittany Region
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Brest, Brittany Region, France, 29200
- Recrutement
- Investigational Site Number: 250603
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Occitanie
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Lunel, Occitanie, France, 34400
- Recrutement
- Investigational Site Number: 250612
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Toulouse, Occitanie, France, 31059
- Recrutement
- Investigational Site Number: 250607
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Pays de la Loire Region
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La Roche-sur-Yon, Pays de la Loire Region, France, 85000
- Recrutement
- Investigational Site Number: 250613
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Île-de-France Region
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Argenteuil, Île-de-France Region, France, 95100
- Recrutement
- Investigational Site Number: 250616
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Créteil, Île-de-France Region, France, 94010
- Recrutement
- Investigational Site Number: 250609
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Niigata, Japon
- Recrutement
- Investigational Site Number: 392707
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Fukuoka
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Kitakyushu-Shi, Fukuoka, Japon, 802-0083
- Recrutement
- Investigational Site Number: 392705
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Kagawa-ken
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Takamatsu, Kagawa-ken, Japon, 761-8073
- Recrutement
- Investigational Site Number: 392702
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Saga-ken
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Saga, Saga-ken, Japon, 849-8501
- Recrutement
- Investigational Site Number: 392711
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Tokyo
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Bunkyo-ku, Tokyo, Japon, 113-8431
- Recrutement
- Investigational Site Number: 392710
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tabashi City, Tokyo, Japon, 173-8610
- Recrutement
- Investigational Site Number: 392709
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Alabama
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Bessemer, Alabama, États-Unis, 35022
- Recrutement
- Trinity Clinical Research, LLC - Bessemer - Site Number: 840150
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Arizona
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Chandler, Arizona, États-Unis, 85224
- Retiré
- Chandler Clinical Trials - Site Number: 840106
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Mesa, Arizona, États-Unis, 85206
- Actif, ne recrute pas
- Del Sol Research Management, LLC - Mesa - Site Number: 840123
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Scottsdale, Arizona, États-Unis, 85254
- Recrutement
- Orso Health - Scottsdale - Site Number: 840133
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Sun City, Arizona, États-Unis, 85351
- Actif, ne recrute pas
- Sun City Clinical Trials - Elite - Site Number: 840120
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California
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California City, California, États-Unis, 91107
- Actif, ne recrute pas
- FOMAT - Huntington Asthma & Allergy Center - Site Number: 840158
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La Palma, California, États-Unis, 90623
- Actif, ne recrute pas
- Imax Clinical Trials - Site Number: 840109
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Los Angeles, California, États-Unis, 90017
- Actif, ne recrute pas
- Downtown LA Research - Site Number: 840161
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Newport Beach, California, États-Unis, 92663
- Actif, ne recrute pas
- Newport Native MD, Inc. - Site Number: 840101
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Pasadena, California, États-Unis, 91101
- Actif, ne recrute pas
- Pasadena Clinical Trials - Site Number: 840116
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Tarzana, California, États-Unis, 91356
- Retiré
- Valiance Clinical Research (JPJ Research) - Site Number: 840135
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Walnut Creek, California, États-Unis, 94598
- Actif, ne recrute pas
- Clinical Research of California - Site Number: 840145
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Florida
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Altamonte Springs, Florida, États-Unis, 32701
- Actif, ne recrute pas
- Cornerstone Research Institute, LLC - Site Number: 840152
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Boca Raton, Florida, États-Unis, 33431
- Actif, ne recrute pas
- 3SYNC Research - Boca Raton - Site Number: 840148
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Brandon, Florida, États-Unis, 33511
- Actif, ne recrute pas
- Meris Clinical Research - Site Number: 840167
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Greenacres City, Florida, États-Unis, 33467
- Actif, ne recrute pas
- Finlay Medical Research - Site Number: 840107
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Miami, Florida, États-Unis, 33126
- Actif, ne recrute pas
- EMDA Clinical Research - Site Number: 840113
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Miami, Florida, États-Unis, 33126
- Actif, ne recrute pas
- Finlay Medical Research - Miami - Site Number: 840110
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Miami, Florida, États-Unis, 33130
- Actif, ne recrute pas
- Care Research Inc. - Site Number: 840103
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Miami, Florida, États-Unis, 33142
- Actif, ne recrute pas
- L&A Morales Healthcare, Inc - Site Number: 840102
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Miami, Florida, États-Unis, 33145
- Actif, ne recrute pas
- MedOne Clinical Research - Site Number: 840122
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Miami, Florida, États-Unis, 33155
- Actif, ne recrute pas
- D&H National Research Centers INC - Site Number: 840128
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Miami, Florida, États-Unis, 33173
- Actif, ne recrute pas
- Research Institute Of South Florida - Site Number: 840149
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Miami, Florida, États-Unis, 33174
- Actif, ne recrute pas
- Valencia Medical & Research Center, Corp - Site Number: 840153
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Miami, Florida, États-Unis, 33186
- Actif, ne recrute pas
- Correa Research Center, Inc. - Site Number: 840141
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Miami Gardens, Florida, États-Unis, 33014
- Actif, ne recrute pas
- Pro Care Research Center - Site Number: 840143
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Miami Lakes, Florida, États-Unis, 33014
- Actif, ne recrute pas
- 3SYNC Research - Miami Lakes - Site Number: 840146
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Miami Lakes, Florida, États-Unis, 33014
- Actif, ne recrute pas
- Deluxe Health Center - Site Number: 840117
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Miami Lakes, Florida, États-Unis, 33016
- Actif, ne recrute pas
- MedQuest Translation Sciences, LLC - Site Number: 840162
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North Miami Beach, Florida, États-Unis, 33169
- Actif, ne recrute pas
- Biscayne Clinical Research - Site Number: 840157
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Palm Springs, Florida, États-Unis, 33406
- Actif, ne recrute pas
- CTMD Research, Inc - Site Number: 840147
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Plantation, Florida, États-Unis, 33317
- Actif, ne recrute pas
- Edward Jenner Research Group, LLC - Site Number: 840169
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Port Saint Lucie, Florida, États-Unis, 34986
- Actif, ne recrute pas
- Mark J. Pamer D.O., LLC - Site Number: 840121
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Tamarac, Florida, États-Unis, 33321
- Actif, ne recrute pas
- TBC Research Corp - Site Number: 840132
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Tampa, Florida, États-Unis, 33613
- Actif, ne recrute pas
- Avita Clinical Research - Tampa - Site Number: 840125
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West Palm Beach, Florida, États-Unis, 33409
- Actif, ne recrute pas
- Palm Beach Medical & Research Center, Inc. - Site Number: 840165
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Georgia
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Columbus, Georgia, États-Unis, 31904
- Actif, ne recrute pas
- The Allergy Center at Brookstone - Site Number: 840114
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Illinois
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Chicago, Illinois, États-Unis, 60616
- Actif, ne recrute pas
- Next Innovation Clinical Research - Chicago - Site Number: 840159
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Kentucky
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Lexington, Kentucky, États-Unis, 40509
- Actif, ne recrute pas
- Bluegrass Allergy Care - Lexington - Site Number:840112
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Maryland
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Columbia, Maryland, États-Unis, 21045
- Recrutement
- Columbia Medical Practice - Site Number: 840172
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Rockville, Maryland, États-Unis, 20854
- Actif, ne recrute pas
- Velocity Clinical Research - Rockville - Site Number: 840163
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- Recrutement
- University of Michigan - Ann Arbor - Site Number: 840140
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Montana
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Missoula, Montana, États-Unis, 59808
- Actif, ne recrute pas
- Montana Medical Research - Site Number: 840137
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Nebraska
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Papillion, Nebraska, États-Unis, 68046
- Actif, ne recrute pas
- Primary Clinical Research, LLC - Papillion - Site Number: 840168
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New Jersey
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Sewell, New Jersey, États-Unis, 08080
- Actif, ne recrute pas
- MedCorps Asthma and Pulmonary Specialists LLC - Sewell - Site Number: 840136
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New York
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Cortland, New York, États-Unis, 13045
- Actif, ne recrute pas
- Finger Lakes Medical Research, PLLC - Site Number: 840155
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New Windsor, New York, États-Unis, 12553
- Actif, ne recrute pas
- Mid Hudson Medical Research, PLLC - Site Number: 840139
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New York, New York, États-Unis, 10029
- Actif, ne recrute pas
- Icahn School of Medicine at Mount Sinai - Center for Advanced Medicine - Site Number: 840119
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North Carolina
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Asheville, North Carolina, États-Unis, 28801
- Actif, ne recrute pas
- Allergy Partners of Western North Carolina - Site Number: 840131
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Gastonia, North Carolina, États-Unis, 28054-7489
- Actif, ne recrute pas
- Clinical Research of Gastonia (CRG) - Site Number: 840160
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Greenville, North Carolina, États-Unis, 27834-2849
- Recrutement
- East Carolina University Physicians - Pulmonary and Critical Care Medicine - Site Number: 840142
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Ohio
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Lima, Ohio, États-Unis, 45801
- Actif, ne recrute pas
- NexGen Research - Site Number: 840154
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Toledo, Ohio, États-Unis, 43617
- Actif, ne recrute pas
- Toledo Institute of Clinical Research Inc - Site Number: 840105
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15241
- Actif, ne recrute pas
- Allergy and Clinical Immunology Associates - Site Number: 840127
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South Carolina
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Rock Hill, South Carolina, États-Unis, 29732
- Actif, ne recrute pas
- Clinical Research of Rock Hill - Site Number: 840115
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Tennessee
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Tennessee City, Tennessee, États-Unis, 30909
- Actif, ne recrute pas
- Allergy Associates, PA dba Allergy, Asthma and Sinus Center - Site Number: 840144
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Texas
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Dallas, Texas, États-Unis, 75235
- Actif, ne recrute pas
- Southwest Family Medicine Associates - Site Number: 840126
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El Paso, Texas, États-Unis, 79902
- Actif, ne recrute pas
- El Paso Pulmonary Association (EPPA) - West El Paso - Site Number: 840108
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Houston, Texas, États-Unis, 77090
- Actif, ne recrute pas
- Lumi Research - Site Number: 840156
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Houston, Texas, États-Unis, 77099
- Actif, ne recrute pas
- Pioneer Research Solutions - Site Number: 840104
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Hurst, Texas, États-Unis, 76054
- Actif, ne recrute pas
- Lumi Research - Hurst - Site Number: 840164
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Tomball, Texas, États-Unis, 77081
- Actif, ne recrute pas
- DM Clinical - Tomball - Site Number: 840130
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Washington
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Bellingham, Washington, États-Unis, 98225
- Actif, ne recrute pas
- Bellingham Asthma, Allergy & Immunology Clinic - Site Number: 840138
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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. |
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-2: A1- Uncontrolled Asthma Cohort
Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of greater than or equal to (>=)1.5 |
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-2: A2- Controlled Asthma Cohort
Participants receiving SoC with Asthma Control Questionnaire-5 (ACQ-5) threshold of less than (<)1.5 |
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-2: B1- Type-2 (T2) High Asthma Cohort
Participants receiving SoC with elevated T2 biomarkers |
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-2: B2- Type-2 Low Asthma Cohort
Participants receiving SoC with low T2 biomarkers |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities
Délai: Part 1: At baseline
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Descriptive Statistical Analyses may include sociodemographic and clinical characteristics, comorbidities, exacerbation history, medication burden, biomarkers and lung function. |
Part 1: At baseline
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Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma
Délai: Part 1: At baseline
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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: At baseline
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Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma
Délai: Part 1: At baseline
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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: At baseline
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Part 1: Physician Global Assessment of Asthma Severity and Symptom Control
Délai: Part 1: At baseline
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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 1: At baseline
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Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2
Délai: Part 2: At Weeks 52 and 104
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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: At Weeks 52 and 104
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Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2
Délai: Part 2: At Weeks 52 and 104
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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: At Weeks 52 and 104
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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
Délai: Part-2: At Weeks 52 and 104
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Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration. |
Part-2: At Weeks 52 and 104
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Partie 1 : Nombre de participants caractérisés par leurs données démographiques et cliniques
Délai: Partie 1 : À partir de 12 mois avant l'inscription à l'étude
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Partie 1 : À partir de 12 mois avant l'inscription à l'étude
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Partie 1 : Nombre de participants caractérisés par leur fardeau de la maladie, leur état de santé et leurs expériences thérapeutiques
Délai: Partie 1 : De 12 mois avant l'inscription à l'étude
|
Partie 1 : De 12 mois avant l'inscription à l'étude
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Partie 1 : Nombre de participants caractérisés par leur utilisation de médicaments
Délai: Partie 1 : À partir des 12 mois précédant l'inscription à l'étude
|
Partie 1 : À partir des 12 mois précédant l'inscription à l'étude
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Partie 1 : Nombre de participants caractérisés par leur mode de vie et leurs influences environnementales
Délai: Partie 1 : À partir de 12 mois avant l'inscription à l'étude
|
Partie 1 : À partir de 12 mois avant l'inscription à l'étude
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Partie 1 : Nombre de participants caractérisés par l'utilisation de corticostéroïdes inhalés et systémiques
Délai: Partie 1 : Des 12 mois précédant l'inscription à l'étude
|
Partie 1 : Des 12 mois précédant l'inscription à l'étude
|
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Partie 1 : Nombre de participants caractérisés par l'utilisation des ressources de soins de santé (HCRU)
Délai: Partie 1 : À partir de 12 mois avant l'inscription à l'étude
|
Partie 1 : À partir de 12 mois avant l'inscription à l'étude
|
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Partie 2 : Caractérisation descriptive incluant les données sociodémographiques, les caractéristiques de la maladie et les antécédents thérapeutiques.
Délai: Partie 2 : Au départ
|
Partie 2 : Au départ
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Partie 2 : Taux annualisés d'exacerbations aux semaines 52 et 104
Délai: Partie 2 : Aux semaines 52 et 104
|
Partie 2 : Aux semaines 52 et 104
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Partie 2 : Nombre de participants analysés pour les modifications de la charge en corticostéroïdes inhalés et systémiques
Délai: Partie 2 : De la date de référence jusqu'à la semaine 104
|
Partie 2 : De la date de référence jusqu'à la semaine 104
|
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Partie 2 : Changements du niveau de biomarqueur
Délai: Partie 2 : aux semaines 52 et 104
|
Partie 2 : aux semaines 52 et 104
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Part 1: Physician-Reported Outcomes to Characterize Physician Perspectives
Délai: 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: From 12 months prior to study enrollment
|
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Part 1: Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Délai: 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 1: From 12 months prior to study enrollment
|
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Part 1: Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score
Délai: 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 1: From 12 months prior to study enrollment
|
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Part 2: Changes From Baseline to Week 104 in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Délai: 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: From baseline to week 52 and week 104
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Part 2: Number of Participants With Significant Changes in Asthma Treatment Patterns at Week 52 and Week 104
Délai: 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: From baseline to week 52 and week 104
|
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Part 2: Changes in Physician Global Assessment of Asthma Severity, Symptom Control and Comorbidities (PhGIS)
Délai: 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: From baseline to week 52 and week 104
|
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Part 2: Number of Participants With Comorbidities and Burden of Comorbidities Based on the Participant Survey Using the PGIS scale
Délai: Part 2: At Weeks 52 and 104
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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: At Weeks 52 and 104
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Part 2: Number of Participants With Comorbidities and Burden of Comorbidities Based on the Physician Survey Using the PhGIS Scale
Délai: Part 2: At Weeks 52 and 104
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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: At Weeks 52 and 104
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Part 2: Changes in Physician-reported HCRU (Hospitalizations, Outpatient and Emergency Visits)
Délai: Part 2: From baseline to week 52 and week 104
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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: From baseline to week 52 and week 104
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Part 2: Changes in Patient-Reported Outcomes to Characterize Disease Evolution
Délai: Part 2: At Weeks 52 and 104
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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: At Weeks 52 and 104
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Part 2: Changes in Participant Survey Response
Délai: Part 2: From baseline to week 52 and week 104
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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 2: From baseline to week 52 and week 104
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Autres numéros d'identification d'étude
- PIR21191
- 2025-524916-13-00 (Ctis)
- U1111-1336-5183 (Identificateur de registre: ICTRP)
- 2025 (Subvention/contrat des NIH des États-Unis)
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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