Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
NCT ID: NCT02537691
Last Updated: 2019-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
483 participants
INTERVENTIONAL
2015-08-28
2017-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Inhaled Corticosteroids (ICS) + Controller Medications
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.
FP
ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.
LABA
LABA will be administered as per investigator discretion.
LTRA
LTRA will be administered as per investigator discretion.
LAMA
LAMA will be administered as per investigator discretion.
Theophylline
Theophylline will be administered as per investigator discretion.
Oral Corticosteroids
Oral corticosteroids will be administered as per investigator discretion.
Interventions
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FP
ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.
LABA
LABA will be administered as per investigator discretion.
LTRA
LTRA will be administered as per investigator discretion.
LAMA
LAMA will be administered as per investigator discretion.
Theophylline
Theophylline will be administered as per investigator discretion.
Oral Corticosteroids
Oral corticosteroids will be administered as per investigator discretion.
Eligibility Criteria
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Inclusion Criteria
* Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1
* Documented bronchodilator response defined as \>/=12% relative improvement in FEV1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (\<) 8 milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline
* Current treatment with a total daily dose of \>/= 500 micrograms (mcg) of fluticasone propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the following controller medications: long-acting Beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/Visit 1
Exclusion Criteria
* Acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to study
* Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline/Visit 1
* Ex-smokers with \>/=10 pack-year smoking history
* Prior treatment with bronchial thermoplasty
* Participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/Visit 1 or during the study
* Pregnancy prior to participation or during the study
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Southern California Research Center
Mission Viejo, California, United States
Capital Allergy Resp Dis Ctr
Sacramento, California, United States
Allergy Assoc Medical Group
San Diego, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Waterbury Pulmonary Associates
Waterbury, Connecticut, United States
AAADRS; Clinical Research Center
Coral Gables, Florida, United States
Volunteer Medical Research
Port Charlotte, Florida, United States
University of South Florida
Tampa, Florida, United States
Georgia Pollens Clinical Research Centers
Albany, Georgia, United States
Asthma & Allergy Center, P.C.
Papillion, Nebraska, United States
Allergy & Asthma Research of Nj, Inc
Mount Laurel, New Jersey, United States
Island Medical Research Pc
Commack, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, United States
Allergy-Asthma Specialists PC
Blue Bell, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Allergy & Clinical Immun Assoc
Pittsburgh, Pennsylvania, United States
Berks-Schuylkill Respiratory Specialists, Ltd
Wyomissing, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Allergy & Asthma Res Ctr PA
San Antonio, Texas, United States
Allergy Associates of Utah
Murray, Utah, United States
Bridgerland Clinical Research
North Logan, Utah, United States
Northridge Internal Medicine
Charlottesville, Virginia, United States
O & O Alpan, LLC
Fairfax, Virginia, United States
ASTHMA, Inc
Seattle, Washington, United States
Pulmonary & Sleep Research
Spokane, Washington, United States
Hospital Erasme; Neurologie
Brussels, , Belgium
Private Practice
Jambes, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHU Sart-Tilman
Liège, , Belgium
CHU UCL Mont-Godinne
Mont-godinne, , Belgium
Mhat - Pleven; Clinic of Pulmonology
Pleven, , Bulgaria
Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
Rousse, , Bulgaria
Vancouver General Hosp; The Lung Centre
Vancouver, British Columbia, Canada
St. Paul's Hospital University of British Colambia Division of Hematology
Vancouver, British Columbia, Canada
Burlington Lung Clinic
Burlington, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Inspiration Research Limited
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital; Endoscopy Department
Montreal, Quebec, Canada
Hopital Laval; Centre de Pneumologie
Québec, , Canada
Hvidovre Hospital, Lungemedicinsk Afdeling
Hvidovre, , Denmark
Lungemedicinsk afd. L, Bispebjerg Hospital
København NV, , Denmark
Hopital Bichat Claude Bernard ; Service de Pneumologie
Paris, , France
Institut für Allergie- und Asthmaforschung Berlin, IAAB
Berlin, , Germany
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
Bochum, , Germany
Lungenzentrum Darmstadt
Darmstadt, , Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, , Germany
Universitätsklinikum Freiburg, Abteilung Pneumologie
Freiburg im Breisgau, , Germany
Pneumologicum
Hanover, , Germany
KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt
Koblenz, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, , Germany
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
München, , Germany
Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
Balassagyarmat, , Hungary
Synexus Magyarorszag Kft
Budapest, , Hungary
Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás
Budapest, , Hungary
Debrecen Uni Medical School; Dept of Pulmonary Medicine
Debrecen, , Hungary
Matrai Állami Gyógyintézet ; Bronchológia
Mátraháza, , Hungary
Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia
Chieti, Abruzzo, Italy
Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio
Modena, Emilia-Romagna, Italy
IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE
Genoa, Liguria, Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia
Turin, Piedmont, Italy
Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
Catania, Sicily, Italy
A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B
Palermo, Sicily, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Tuscany, Italy
Clinical Hospital Gailezers; Dept of Pulmonology
Riga, , Latvia
Riga 1st hospital, outpatient clinic Bruninieks
Riga, , Latvia
Latvian University postgraduate institute
Riga, , Latvia
Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
Hoofddorp, , Netherlands
Medisch Centrum Leeuwarden; Longziekten
Leeuwarden, , Netherlands
St. Antonius; R&D Long
Nieuwegein, , Netherlands
CHVNG/E_Unidade 1; Servico de Pneumologia
Vila Nova de Gaia, , Portugal
Research Institute of Complex Cardiovascular Pathology
Kemerovo, , 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, , Russia
SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology
Moscow, , Russia
SBHI of NN region "RCH of NN n.a. N.A.Semashko"
Nizhny Novgorod, , Russia
City Hospital #40 of Resort Administrative District
Saint Petersburg, , Russia
City Out-patient Clinic #106
Saint Petersburg, , Russia
Saratov State Medical University; Chair Of Clinical Allergology
Saratov, , 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, Spain
Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
Majadahonda, Madrid, Spain
Hospital de Galdakano; Servicio de Neumologia
Galdakano, Vizcaya, Spain
Fundacio Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Clinic I provincial; Servicio de Neumologia
Barcelona, , Spain
Hospital Universitario Reina Sofia; Servicio de Neumología
Córdoba, , Spain
Hospital Universitario 12 de Octubre; Servicio de Neumologia
Madrid, , Spain
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
William Harvey Research Institute
London, , United Kingdom
St George's Hospital
London, , United Kingdom
North Manchester Hospital; Respiratory Department
Manchester, , United Kingdom
Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre
Newcastle upon Tyne, , United Kingdom
Queen Alexandra Hospital, Portsmouth
Portsmouth, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Countries
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Other Identifiers
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2015-000742-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MB29599
Identifier Type: -
Identifier Source: org_study_id
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