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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000742-35 | EudraCT Number |
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Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Corticosteroids (ICS) + Controller Medications | Other | Participants with severe asthma Global Initiative for Asthma (GINA) step 4/5 as indicated by current treatment with daily ICS consisting of >/=500 mcg FP administered by DPI (or equivalent), and at least one of the following controller medications: LABAs, LTRAs, LAMAs, theophylline or oral corticosteroids. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP | Drug | ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin | Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Asthma Exacerbations | Baseline up to Week 52 | |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points | Baseline, Weeks 26, 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35209 | United States | ||
| Southern California Research Center |
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| LABA | Drug | LABA will be administered as per investigator discretion. |
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| LTRA | Drug | LTRA will be administered as per investigator discretion. |
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| LAMA | Drug | LAMA will be administered as per investigator discretion. |
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| Theophylline | Drug | Theophylline will be administered as per investigator discretion. |
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| Oral Corticosteroids | Drug | Oral corticosteroids will be administered as per investigator discretion. |
|
| Time Taken for the Occurrence of First Asthma Exacerbation | Baseline up to Week 52 |
| Time to Treatment Failure | Baseline up to Week 52 |
| Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points | Baseline, Weeks 13, 26, 39, 52 |
| Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points | Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) |
| Change From Baseline in Asthma Control Test (ACT) at Specified Time Points | Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) |
| Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee | Baseline up to Week 52 |
| Serum Periostin Levels During the Study | Baseline, Weeks 26, 52 |
| Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels | Baseline, Weeks 26, 52 |
| Blood Eosinophil Levels During the Study | Baseline, Weeks 26, 52 |
| Serum Immunoglobulin E (IgE) Levels During the Study | Baseline, Weeks 26, 52 |
| Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations | Weeks 13, 26, 39, 52 |
| Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits | Weeks 13, 26, 39, 52 |
| Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits | Weeks 13, 26, 39, 52 |
| Mission Viejo |
| California |
| 92691 |
| United States |
| Capital Allergy Resp Dis Ctr | Sacramento | California | 95819 | United States |
| Allergy Assoc Medical Group | San Diego | California | 92108 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Waterbury Pulmonary Associates | Waterbury | Connecticut | 06708 | United States |
| AAADRS; Clinical Research Center | Coral Gables | Florida | 33134 | United States |
| Volunteer Medical Research | Port Charlotte | Florida | 33952 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Georgia Pollens Clinical Research Centers | Albany | Georgia | 31707 | United States |
| Asthma & Allergy Center, P.C. | Papillion | Nebraska | 68046 | United States |
| Allergy & Asthma Research of Nj, Inc | Mount Laurel | New Jersey | 08054 | United States |
| Island Medical Research Pc | Commack | New York | 11725 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Laura and ISAAC Perlmutter Cancer Center at NYU Langone. | New York | New York | 10016 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Vital Prospects Clin Res Pc | Tulsa | Oklahoma | 74136 | United States |
| Allergy-Asthma Specialists PC | Blue Bell | Pennsylvania | 19422 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Allergy & Clinical Immun Assoc | Pittsburgh | Pennsylvania | 15241 | United States |
| Berks-Schuylkill Respiratory Specialists, Ltd | Wyomissing | Pennsylvania | 19610 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Allergy & Asthma Res Ctr PA | San Antonio | Texas | 78251 | United States |
| Allergy Associates of Utah | Murray | Utah | 84107 | United States |
| Bridgerland Clinical Research | North Logan | Utah | 84341 | United States |
| Northridge Internal Medicine | Charlottesville | Virginia | 22903 | United States |
| O & O Alpan, LLC | Fairfax | Virginia | 22030 | United States |
| ASTHMA, Inc | Seattle | Washington | 98105 | United States |
| Pulmonary & Sleep Research | Spokane | Washington | 99204 | United States |
| Hospital Erasme; Neurologie | Brussels | 1070 | Belgium |
| Private Practice | Jambes | 5100 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| CHU UCL Mont-Godinne | Mont-godinne | 5530 | Belgium |
| Mhat - Pleven; Clinic of Pulmonology | Pleven | 5800 | Bulgaria |
| Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases | Rousse | 7002 | Bulgaria |
| Vancouver General Hosp; The Lung Centre | Vancouver | British Columbia | V5Z 1L7 | Canada |
| St. Paul's Hospital University of British Colambia Division of Hematology | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Burlington Lung Clinic | Burlington | Ontario | L7N 3V2 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V6 | Canada |
| Inspiration Research Limited | Toronto | Ontario | M5T 3A9 | Canada |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2X 3E4 | Canada |
| Jewish General Hospital; Endoscopy Department | Montreal | Quebec | H3T 1E2 | Canada |
| Hopital Laval; Centre de Pneumologie | Québec | G1V 4G5 | Canada |
| Hvidovre Hospital, Lungemedicinsk Afdeling | Hvidovre | 2650 | Denmark |
| Lungemedicinsk afd. L, Bispebjerg Hospital | København NV | 2400 | Denmark |
| Hopital Bichat Claude Bernard ; Service de Pneumologie | Paris | 75877 | France |
| Institut für Allergie- und Asthmaforschung Berlin, IAAB | Berlin | 12159 | Germany |
| Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH | Bochum | 44789 | Germany |
| Lungenzentrum Darmstadt | Darmstadt | 64283 | Germany |
| Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie | Essen | 45239 | Germany |
| Universitätsklinikum Freiburg, Abteilung Pneumologie | Freiburg im Breisgau | 79106 | Germany |
| Pneumologicum | Hanover | 30173 | Germany |
| KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt | Koblenz | 56068 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie | Mainz | 55131 | Germany |
| Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V | München | 81377 | Germany |
| Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept ) | Balassagyarmat | 2660 | Hungary |
| Synexus Magyarorszag Kft | Budapest | 1036 | Hungary |
| Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás | Budapest | 1122 | Hungary |
| Debrecen Uni Medical School; Dept of Pulmonary Medicine | Debrecen | 4032 | Hungary |
| Matrai Állami Gyógyintézet ; Bronchológia | Mátraháza | 3233 | Hungary |
| Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia | Chieti | Abruzzo | 66100 | Italy |
| Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio | Modena | Emilia-Romagna | 41124 | Italy |
| IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE | Genoa | Liguria | 16132 | Italy |
| AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia | Turin | Piedmont | 10126 | Italy |
| Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia | Catania | Sicily | 95123 | Italy |
| A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B | Palermo | Sicily | 90146 | Italy |
| A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii | Pisa | Tuscany | 56124 | Italy |
| Clinical Hospital Gailezers; Dept of Pulmonology | Riga | 1038 | Latvia |
| Riga 1st hospital, outpatient clinic Bruninieks | Riga | LV-1001 | Latvia |
| Latvian University postgraduate institute | Riga | LV-1011 | Latvia |
| Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde | Hoofddorp | 2134 TM | Netherlands |
| Medisch Centrum Leeuwarden; Longziekten | Leeuwarden | 8934 AD | Netherlands |
| St. Antonius; R&D Long | Nieuwegein | 3435 CM | Netherlands |
| CHVNG/E_Unidade 1; Servico de Pneumologia | Vila Nova de Gaia | 4434-502 | Portugal |
| Research Institute of Complex Cardiovascular Pathology | Kemerovo | 650002 | Russia |
| SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region | Krasnodar | Russia |
| FSBI "National Research Center - Institute of Immunology" of FMBA of Russia | Moscow | 115478 | Russia |
| SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology | Moscow | 125993 | Russia |
| SBHI of NN region "RCH of NN n.a. N.A.Semashko" | Nizhny Novgorod | 603126 | Russia |
| City Hospital #40 of Resort Administrative District | Saint Petersburg | 197706 | Russia |
| City Out-patient Clinic #106 | Saint Petersburg | 198328 | Russia |
| Saratov State Medical University; Chair Of Clinical Allergology | Saratov | 410012 | Russia |
| SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia | Vladikavkaz | Russia |
| Complexo Hospitalario Universitario de Santiago | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología | Majadahonda | Madrid | 28222 | Spain |
| Hospital de Galdakano; Servicio de Neumologia | Galdakano | Vizcaya | 48960 | Spain |
| Fundacio Santa Creu I Sant Pau | Barcelona | 08006 | Spain |
| Hospital Clinic I provincial; Servicio de Neumologia | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Neumología | Córdoba | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neumologia | Madrid | 28041 | Spain |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Gloucestershire Royal Hospital | Gloucester | GL1 3NN | United Kingdom |
| William Harvey Research Institute | London | EC1M 6BQ | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| North Manchester Hospital; Respiratory Department | Manchester | M8 5RB | United Kingdom |
| Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Queen Alexandra Hospital, Portsmouth | Portsmouth | PO6 3LY | United Kingdom |
| Royal Shrewsbury Hospital | Shrewsbury | SY3 8XQ | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013806 | Theophylline |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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