En studie som evaluerer sykdomskarakteristikker og utfall hos deltakere med astma i klinisk rutinepraksis (AIRITY)
En hybrid tverrsnitts- og prospektiv studie for å vurdere pasientkarakteristikker, sykdomsbyrde, sykdomskontroll, fenotyper, endotyper og utfall i en virkelig verden-setting hos pasienter med astma
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Trial Transparency email recommended-Toll free for US & Canada
- Telefonnummer: 6 800-633-1610
- E-post: Contact-US@sanofi.com
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T3R 1W7
- Rekruttering
- Investigational Site Number: 124203
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Ontario
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Windsor, Ontario, Canada, N8X 2G1
- Rekruttering
- Investigational Site Number: 124201
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Quebec
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Trois-Rivières, Quebec, Canada, G8T7A1
- Rekruttering
- Investigational Site Number: 124204
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Alabama
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Bessemer, Alabama, Forente stater, 35022
- Rekruttering
- Trinity Clinical Research, LLC - Bessemer - Site Number: 840150
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Tilbaketrukket
- Chandler Clinical Trials - Site Number: 840106
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Mesa, Arizona, Forente stater, 85206
- Aktiv, ikke rekrutterende
- Del Sol Research Management, LLC - Mesa - Site Number: 840123
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Scottsdale, Arizona, Forente stater, 85254
- Rekruttering
- Orso Health - Scottsdale - Site Number: 840133
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Sun City, Arizona, Forente stater, 85351
- Aktiv, ikke rekrutterende
- Sun City Clinical Trials - Elite - Site Number: 840120
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California
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California City, California, Forente stater, 91107
- Aktiv, ikke rekrutterende
- FOMAT - Huntington Asthma & Allergy Center - Site Number: 840158
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La Palma, California, Forente stater, 90623
- Aktiv, ikke rekrutterende
- Imax Clinical Trials - Site Number: 840109
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Los Angeles, California, Forente stater, 90017
- Aktiv, ikke rekrutterende
- Downtown LA Research - Site Number: 840161
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Newport Beach, California, Forente stater, 92663
- Aktiv, ikke rekrutterende
- Newport Native MD, Inc. - Site Number: 840101
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Pasadena, California, Forente stater, 91101
- Aktiv, ikke rekrutterende
- Pasadena Clinical Trials - Site Number: 840116
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Tarzana, California, Forente stater, 91356
- Tilbaketrukket
- Valiance Clinical Research (JPJ Research) - Site Number: 840135
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Walnut Creek, California, Forente stater, 94598
- Aktiv, ikke rekrutterende
- Clinical Research of California - Site Number: 840145
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Florida
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Altamonte Springs, Florida, Forente stater, 32701
- Aktiv, ikke rekrutterende
- Cornerstone Research Institute, LLC - Site Number: 840152
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Boca Raton, Florida, Forente stater, 33431
- Aktiv, ikke rekrutterende
- 3SYNC Research - Boca Raton - Site Number: 840148
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Brandon, Florida, Forente stater, 33511
- Aktiv, ikke rekrutterende
- Meris Clinical Research - Site Number: 840167
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Greenacres City, Florida, Forente stater, 33467
- Aktiv, ikke rekrutterende
- Finlay Medical Research - Site Number: 840107
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Miami, Florida, Forente stater, 33126
- Aktiv, ikke rekrutterende
- EMDA Clinical Research - Site Number: 840113
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Miami, Florida, Forente stater, 33126
- Aktiv, ikke rekrutterende
- Finlay Medical Research - Miami - Site Number: 840110
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Miami, Florida, Forente stater, 33130
- Aktiv, ikke rekrutterende
- Care Research Inc. - Site Number: 840103
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Miami, Florida, Forente stater, 33142
- Aktiv, ikke rekrutterende
- L&A Morales Healthcare, Inc - Site Number: 840102
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Miami, Florida, Forente stater, 33145
- Aktiv, ikke rekrutterende
- MedOne Clinical Research - Site Number: 840122
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Miami, Florida, Forente stater, 33155
- Aktiv, ikke rekrutterende
- D&H National Research Centers INC - Site Number: 840128
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Miami, Florida, Forente stater, 33173
- Aktiv, ikke rekrutterende
- Research Institute Of South Florida - Site Number: 840149
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Miami, Florida, Forente stater, 33174
- Aktiv, ikke rekrutterende
- Valencia Medical & Research Center, Corp - Site Number: 840153
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Miami, Florida, Forente stater, 33186
- Aktiv, ikke rekrutterende
- Correa Research Center, Inc. - Site Number: 840141
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Miami Gardens, Florida, Forente stater, 33014
- Aktiv, ikke rekrutterende
- Pro Care Research Center - Site Number: 840143
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Miami Lakes, Florida, Forente stater, 33014
- Aktiv, ikke rekrutterende
- 3SYNC Research - Miami Lakes - Site Number: 840146
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Miami Lakes, Florida, Forente stater, 33014
- Aktiv, ikke rekrutterende
- Deluxe Health Center - Site Number: 840117
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Miami Lakes, Florida, Forente stater, 33016
- Aktiv, ikke rekrutterende
- MedQuest Translation Sciences, LLC - Site Number: 840162
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North Miami Beach, Florida, Forente stater, 33169
- Aktiv, ikke rekrutterende
- Biscayne Clinical Research - Site Number: 840157
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Palm Springs, Florida, Forente stater, 33406
- Aktiv, ikke rekrutterende
- CTMD Research, Inc - Site Number: 840147
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Plantation, Florida, Forente stater, 33317
- Aktiv, ikke rekrutterende
- Edward Jenner Research Group, LLC - Site Number: 840169
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Port Saint Lucie, Florida, Forente stater, 34986
- Aktiv, ikke rekrutterende
- Mark J. Pamer D.O., LLC - Site Number: 840121
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Tamarac, Florida, Forente stater, 33321
- Aktiv, ikke rekrutterende
- TBC Research Corp - Site Number: 840132
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Tampa, Florida, Forente stater, 33613
- Aktiv, ikke rekrutterende
- Avita Clinical Research - Tampa - Site Number: 840125
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West Palm Beach, Florida, Forente stater, 33409
- Aktiv, ikke rekrutterende
- Palm Beach Medical & Research Center, Inc. - Site Number: 840165
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Georgia
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Columbus, Georgia, Forente stater, 31904
- Aktiv, ikke rekrutterende
- The Allergy Center at Brookstone - Site Number: 840114
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Illinois
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Chicago, Illinois, Forente stater, 60616
- Aktiv, ikke rekrutterende
- Next Innovation Clinical Research - Chicago - Site Number: 840159
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Kentucky
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Lexington, Kentucky, Forente stater, 40509
- Aktiv, ikke rekrutterende
- Bluegrass Allergy Care - Lexington - Site Number:840112
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Maryland
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Columbia, Maryland, Forente stater, 21045
- Rekruttering
- Columbia Medical Practice - Site Number: 840172
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Rockville, Maryland, Forente stater, 20854
- Aktiv, ikke rekrutterende
- Velocity Clinical Research - Rockville - Site Number: 840163
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Rekruttering
- University of Michigan - Ann Arbor - Site Number: 840140
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Montana
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Missoula, Montana, Forente stater, 59808
- Aktiv, ikke rekrutterende
- Montana Medical Research - Site Number: 840137
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Nebraska
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Papillion, Nebraska, Forente stater, 68046
- Aktiv, ikke rekrutterende
- Primary Clinical Research, LLC - Papillion - Site Number: 840168
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New Jersey
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Sewell, New Jersey, Forente stater, 08080
- Aktiv, ikke rekrutterende
- MedCorps Asthma and Pulmonary Specialists LLC - Sewell - Site Number: 840136
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New York
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Cortland, New York, Forente stater, 13045
- Aktiv, ikke rekrutterende
- Finger Lakes Medical Research, PLLC - Site Number: 840155
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New Windsor, New York, Forente stater, 12553
- Aktiv, ikke rekrutterende
- Mid Hudson Medical Research, PLLC - Site Number: 840139
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New York, New York, Forente stater, 10029
- Aktiv, ikke rekrutterende
- 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, Forente stater, 28801
- Aktiv, ikke rekrutterende
- Allergy Partners of Western North Carolina - Site Number: 840131
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Gastonia, North Carolina, Forente stater, 28054-7489
- Aktiv, ikke rekrutterende
- Clinical Research of Gastonia (CRG) - Site Number: 840160
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Greenville, North Carolina, Forente stater, 27834-2849
- Rekruttering
- East Carolina University Physicians - Pulmonary and Critical Care Medicine - Site Number: 840142
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Ohio
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Lima, Ohio, Forente stater, 45801
- Aktiv, ikke rekrutterende
- NexGen Research - Site Number: 840154
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Toledo, Ohio, Forente stater, 43617
- Aktiv, ikke rekrutterende
- Toledo Institute of Clinical Research Inc - Site Number: 840105
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15241
- Aktiv, ikke rekrutterende
- Allergy and Clinical Immunology Associates - Site Number: 840127
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South Carolina
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Rock Hill, South Carolina, Forente stater, 29732
- Aktiv, ikke rekrutterende
- Clinical Research of Rock Hill - Site Number: 840115
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Tennessee
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Tennessee City, Tennessee, Forente stater, 30909
- Aktiv, ikke rekrutterende
- Allergy Associates, PA dba Allergy, Asthma and Sinus Center - Site Number: 840144
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Texas
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Dallas, Texas, Forente stater, 75235
- Aktiv, ikke rekrutterende
- Southwest Family Medicine Associates - Site Number: 840126
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El Paso, Texas, Forente stater, 79902
- Aktiv, ikke rekrutterende
- El Paso Pulmonary Association (EPPA) - West El Paso - Site Number: 840108
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Houston, Texas, Forente stater, 77090
- Aktiv, ikke rekrutterende
- Lumi Research - Site Number: 840156
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Houston, Texas, Forente stater, 77099
- Aktiv, ikke rekrutterende
- Pioneer Research Solutions - Site Number: 840104
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Hurst, Texas, Forente stater, 76054
- Aktiv, ikke rekrutterende
- Lumi Research - Hurst - Site Number: 840164
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Tomball, Texas, Forente stater, 77081
- Aktiv, ikke rekrutterende
- DM Clinical - Tomball - Site Number: 840130
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Washington
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Bellingham, Washington, Forente stater, 98225
- Aktiv, ikke rekrutterende
- Bellingham Asthma, Allergy & Immunology Clinic - Site Number: 840138
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Brittany Region
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Brest, Brittany Region, Frankrike, 29200
- Rekruttering
- Investigational Site Number: 250603
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Occitanie
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Lunel, Occitanie, Frankrike, 34400
- Rekruttering
- Investigational Site Number: 250612
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Toulouse, Occitanie, Frankrike, 31059
- Rekruttering
- 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, Frankrike, 85000
- Rekruttering
- Investigational Site Number: 250613
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Île-de-France Region
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Argenteuil, Île-de-France Region, Frankrike, 95100
- Rekruttering
- Investigational Site Number: 250616
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Créteil, Île-de-France Region, Frankrike, 94010
- Rekruttering
- Investigational Site Number: 250609
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Niigata, Japan
- Rekruttering
- Investigational Site Number: 392707
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Fukuoka
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Kitakyushu-Shi, Fukuoka, Japan, 802-0083
- Rekruttering
- Investigational Site Number: 392705
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Kagawa-ken
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Takamatsu, Kagawa-ken, Japan, 761-8073
- Rekruttering
- Investigational Site Number: 392702
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Saga-ken
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Saga, Saga-ken, Japan, 849-8501
- Rekruttering
- Investigational Site Number: 392711
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Rekruttering
- Investigational Site Number: 392710
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tabashi City, Tokyo, Japan, 173-8610
- Rekruttering
- Investigational Site Number: 392709
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Madrid, Spania, 28034
- Rekruttering
- Investigational Site Number: 724408
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Bayern (Bavaria)
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München, Bayern (Bavaria), Tyskland, 85039
- Rekruttering
- Investigational Site Number: 276503
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Tyskland, 53119
- Rekruttering
- Investigational Site Number: 276505
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Saxony
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Hohenstein-Ernstthal, Saxony, Tyskland, 09337
- Rekruttering
- Investigational Site Number: 276501
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Schleswig-Holstein
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Schleswig, Schleswig-Holstein, Tyskland, 24837
- Rekruttering
- Investigational Site Number: 276502
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities
Tidsramme: Part 1: At baseline
|
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
Tidsramme: 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: At baseline
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Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma
Tidsramme: 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: At baseline
|
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Part 1: Physician Global Assessment of Asthma Severity and Symptom Control
Tidsramme: 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 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
Tidsramme: 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: 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
Tidsramme: 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: 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
Tidsramme: 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-2: At Weeks 52 and 104
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Del 1: Antall deltakere karakterisert etter demografi og kliniske kjennetegn
Tidsramme: Del 1: Fra 12 måneder før studiedeltakelse
|
Del 1: Fra 12 måneder før studiedeltakelse
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Del 1: Antall deltakere karakterisert etter sykdomsbyrde, helsestatus, behandlingserfaringer
Tidsramme: Del 1: Fra 12 måneder før studiestart
|
Del 1: Fra 12 måneder før studiestart
|
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Del 1: Antall deltakere karakterisert etter medikamentbruk
Tidsramme: Del 1: Fra 12 måneder før studiestart
|
Del 1: Fra 12 måneder før studiestart
|
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Del 1: Antall deltakere karakterisert ved deres livsstil og miljøpåvirkninger
Tidsramme: Del 1: Fra 12 måneder før studiedeltakelse
|
Del 1: Fra 12 måneder før studiedeltakelse
|
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Del 1: Antall deltakere karakterisert ved bruk av inhalerte og systemiske kortikosteroider
Tidsramme: Del 1: Fra 12 måneder før studiestart
|
Del 1: Fra 12 måneder før studiestart
|
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Del 1: Antall deltakere karakterisert etter bruk av helsetjenesteressurser (HCRU)
Tidsramme: Del 1: Fra 12 måneder før studiestart
|
Del 1: Fra 12 måneder før studiestart
|
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Del 2: Beskrivende karakterisering inkludert sosiademografi og sykdomskarakteristika og behandlingshistorie.
Tidsramme: Del 2: Ved baseline
|
Del 2: Ved baseline
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Del 2: Annualiserte eksaserbasjonsrater ved uke 52 og 104
Tidsramme: Del 2: I uke 52 og 104
|
Del 2: I uke 52 og 104
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Del 2: Antall deltakere analysert for endringer i belastning av inhalerte og systemiske kortikosteroider
Tidsramme: Del 2: Fra baseline til uke 104
|
Del 2: Fra baseline til uke 104
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Del 2: Endringer i Biomarkørnivå
Tidsramme: Part 2: At Weeks 52 and 104
|
Part 2: At Weeks 52 and 104
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Part 1: Physician-Reported Outcomes to Characterize Physician Perspectives
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre studie-ID-numre
- PIR21191
- 2025-524916-13-00 (Ctis)
- U1111-1336-5183 (Registeridentifikator: ICTRP)
- 2025 (U.S. NIH-stipend/kontrakt)
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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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