Cross-sectional Study for Identification and Description of Severe Asthma Patients
31. mars 2016 oppdatert av: GlaxoSmithKline
Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study
This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day.
Investigational product will not be administered.
Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects.
The study will not include a run-in or follow-up period.
This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab.
This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab.
Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
767
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
- GSK Investigational Site
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Alberta
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Sherwood Park, Alberta, Canada, T8H 0N2
- GSK Investigational Site
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
- GSK Investigational Site
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Burlington, Ontario, Canada, L7N 3V2
- GSK Investigational Site
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Grimsby, Ontario, Canada, L3M1P3
- GSK Investigational Site
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London, Ontario, Canada, N6A1V2
- GSK Investigational Site
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Mississauga, Ontario, Canada, L5A 3V4
- GSK Investigational Site
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St-Charles-Borromée, Ontario, Canada, J6E 2B4
- GSK Investigational Site
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Toronto, Ontario, Canada, M5G 1E2
- GSK Investigational Site
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Toronto, Ontario, Canada, M5T 3A9
- GSK Investigational Site
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Windsor, Ontario, Canada, N8X2G1
- GSK Investigational Site
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
- GSK Investigational Site
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Quebec City, Quebec, Canada, G1V 4M6
- GSK Investigational Site
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Québec, Quebec, Canada, G1V 4G5
- GSK Investigational Site
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Trois Rivières, Quebec, Canada, G8T 7A1
- GSK Investigational Site
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- GSK Investigational Site
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California
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Fresno, California, Forente stater, 93720
- GSK Investigational Site
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Los Angeles, California, Forente stater, 90025
- GSK Investigational Site
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Newport Beach, California, Forente stater, 92663
- GSK Investigational Site
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Riverside, California, Forente stater, 92506
- GSK Investigational Site
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Rolling Hills Estates, California, Forente stater, 90274
- GSK Investigational Site
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San Diego, California, Forente stater, 92123
- GSK Investigational Site
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Upland, California, Forente stater, 91786
- GSK Investigational Site
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Florida
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Tallahassee, Florida, Forente stater, 32308
- GSK Investigational Site
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Kentucky
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Owensboro, Kentucky, Forente stater, 42301
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, Forente stater, 21236
- GSK Investigational Site
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Columbia, Maryland, Forente stater, 21044
- GSK Investigational Site
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55402
- GSK Investigational Site
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Plymouth, Minnesota, Forente stater, 55441
- GSK Investigational Site
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New York
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Corning, New York, Forente stater, 14830
- GSK Investigational Site
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North Carolina
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Charlotte, North Carolina, Forente stater, 28277
- GSK Investigational Site
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Shelby, North Carolina, Forente stater, 28150
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, Forente stater, 45231
- GSK Investigational Site
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Oregon
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Medford, Oregon, Forente stater, 97504
- GSK Investigational Site
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15241
- GSK Investigational Site
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- GSK Investigational Site
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Bayonne cedex, Frankrike, 64109
- GSK Investigational Site
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Dijon Cedex, Frankrike, 21033
- GSK Investigational Site
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Grenoble cedex 9, Frankrike, 38043
- GSK Investigational Site
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Lille Cedex, Frankrike, 59037
- GSK Investigational Site
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Lyon cedex 04, Frankrike, 69317
- GSK Investigational Site
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Marseille cedex 03, Frankrike, 13331
- GSK Investigational Site
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Nantes cedex 1, Frankrike, 44093
- GSK Investigational Site
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Nantes cedex 2, Frankrike, 44277
- GSK Investigational Site
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Paris Cedex 18, Frankrike, 75877
- GSK Investigational Site
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Pessac cedex, Frankrike, 33604
- GSK Investigational Site
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Reims Cedex, Frankrike, 51092
- GSK Investigational Site
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Rouen Cedex, Frankrike, 76031
- GSK Investigational Site
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Strasbourg, Frankrike, 67091
- GSK Investigational Site
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Tarbes cedex 9, Frankrike, 65013
- GSK Investigational Site
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Villefranche sur Saône, Frankrike, 69655
- GSK Investigational Site
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Birmingham, Storbritannia, B15 2WB
- GSK Investigational Site
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Birmingham, Storbritannia, B18 7QH
- GSK Investigational Site
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Cambridge, Storbritannia, CB2 2XY
- GSK Investigational Site
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Crawley, Storbritannia, RH10 7DX
- GSK Investigational Site
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Liverpool, Storbritannia, L12 2AP
- GSK Investigational Site
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London, Storbritannia, SW17 0RE
- GSK Investigational Site
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Middlesbrough, Storbritannia, TS4 3BW
- GSK Investigational Site
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Radstock, Bath, Storbritannia, BA3 2UH
- GSK Investigational Site
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Salford, Storbritannia, M6 8HD
- GSK Investigational Site
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Trowbridge, Storbritannia, BA14 9AR
- GSK Investigational Site
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Berlin, Tyskland, 13086
- GSK Investigational Site
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Berlin, Tyskland, 10717
- GSK Investigational Site
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Berlin, Tyskland, 13597
- GSK Investigational Site
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Berlin, Tyskland, 12203
- GSK Investigational Site
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Berlin, Tyskland, 12157
- GSK Investigational Site
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Hamburg, Tyskland, 22299
- GSK Investigational Site
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Bayern
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Gauting, Bayern, Tyskland, 82131
- GSK Investigational Site
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Muenchen, Bayern, Tyskland, 80539
- GSK Investigational Site
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Brandenburg
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Cottbus, Brandenburg, Tyskland, 03050
- GSK Investigational Site
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Sachsen
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Leipzig, Sachsen, Tyskland, 04357
- GSK Investigational Site
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Leipzig, Sachsen, Tyskland, 04103
- GSK Investigational Site
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, Tyskland, 23552
- GSK Investigational Site
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Schleswig, Schleswig-Holstein, Tyskland, 24837
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- At least 12 years of age at study visit.
- Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Society (ERS/ATS) Guidelines for severe asthma: Asthma which requires treatment with guideline suggested medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous year (i.e., at least 12 months).
Patients must be treated with high dose ICS PLUS at least one of the following: LABA, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year).
SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the maximum recommended dose of the ICS/LABA combination per local label is acceptable.
- Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. A parent or legal guardian must provide informed consent for participants less than 18 years of age at study visit (or less than minimum age to be considered an adult per local laws).
Exclusion Criteria:
Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Non-drug interventional group
All enrolled participants will provide a blood sample, spirometry , and feedback on their severe asthma symptoms via questionnaires, and health related quality of life and burden of illness through response to self-administered questionnaires.
No investigational product will be administered to participants.
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Participants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of severe asthma patients eligible for one or more biologic treatments for asthma
Tidsramme: Day 1
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Biologic treatments for asthma will include mepolizumab (anti-Interleukin [IL] 5), omalizumab (anti-immunoglobulin E [IgE]), and reslizumab (anti-IL5).
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Day 1
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
Tidsramme: Day 1
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Day 1
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Mean and median Charlson Comorbidity Index score
Tidsramme: Day 1
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The Charlson Comorbidity Index is a score that is based on age and the presence of 19 comorbidities.
The mean and median Charlson Comorbidity Index score will be calculated and reported
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Day 1
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Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio
Tidsramme: Day 1
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Day 1
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Mean post-bronchodilator FEV1/FVC ratio
Tidsramme: Day 1
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Day 1
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Mean pre-bronchodilator FEV1
Tidsramme: Day 1
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Day 1
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Mean post-bronchodilator FEV1
Tidsramme: Day 1
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Day 1
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Mean pre-bronchodilator FVC
Tidsramme: Day 1
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Day 1
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Mean post-bronchodilator FVC
Tidsramme: Day 1
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Day 1
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Mean and median levels of blood eosinophils
Tidsramme: Day 1
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Day 1
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Mean and median levels of total IgE
Tidsramme: Day 1
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Day 1
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Mean and median levels of specific IgE
Tidsramme: Day 1
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Day 1
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Descriptive statistics for asthma Control Questionnaire (ACQ-5)
Tidsramme: Day 1
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Day 1
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Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)
Tidsramme: Day 1
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Day 1
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Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)
Tidsramme: Day 1
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Day 1
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Descriptive statistics for EuroQol 5D (EQ-5D-5L)
Tidsramme: Day 1
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Day 1
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Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)
Tidsramme: Day 1
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Day 1
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Descriptive statistics for Asthma Symptom Utility Index (ASUI)
Tidsramme: Day 1
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Day 1
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.
- Mullerova H, Cockle SM, Gunsoy NB, Nelsen LM, Albers FC. Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study. J Asthma. 2021 Apr;58(4):459-470. doi: 10.1080/02770903.2019.1708095. Epub 2020 Jan 9.
- Albers FC, Mullerova H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2018 Feb;55(2):152-160. doi: 10.1080/02770903.2017.1322611. Epub 2017 Jun 16.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2014
Primær fullføring (Faktiske)
1. mai 2015
Studiet fullført (Faktiske)
1. mai 2015
Datoer for studieregistrering
Først innsendt
27. oktober 2014
Først innsendt som oppfylte QC-kriteriene
13. november 2014
Først lagt ut (Anslag)
18. november 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. april 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201722
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .