Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT02537691
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
- Asthma diagnosed by a respiratory physician greater than or equal to (>/=) 12 months prior to study enrolment
- 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
- Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks prior to participant eligibility
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inhaled Corticosteroids (ICS) + Controller Medications FP 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. Inhaled Corticosteroids (ICS) + Controller Medications LABA 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. Inhaled Corticosteroids (ICS) + Controller Medications LTRA 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. Inhaled Corticosteroids (ICS) + Controller Medications Oral Corticosteroids 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. Inhaled Corticosteroids (ICS) + Controller Medications LAMA 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. Inhaled Corticosteroids (ICS) + Controller Medications Theophylline 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.
- Primary Outcome Measures
Name Time Method Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin Baseline up to Week 52
- Secondary Outcome Measures
Name Time Method Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points Baseline, Weeks 26, 52 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 Percentage of Participants With Asthma Exacerbations Baseline up to Week 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
Trial Locations
- Locations (100)
Riga 1st hospital, outpatient clinic Bruninieks
🇱🇻Riga, Latvia
Clinical Hospital Gailezers; Dept of Pulmonology
🇱🇻Riga, Latvia
Latvian University postgraduate institute
🇱🇻Riga, Latvia
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
CHU UCL Mont-Godinne
🇧🇪Mont-godinne, Belgium
City Out-patient Clinic #106
🇷🇺Saint-Petersburg, Russian Federation
Volunteer Medical Research
🇺🇸Port Charlotte, Florida, United States
Georgia Pollens Clinical Research Centers
🇺🇸Albany, Georgia, United States
Berks-Schuylkill Respiratory Specialists, Ltd
🇺🇸Wyomissing, Pennsylvania, United States
Mhat - Pleven; Clinic of Pulmonology
🇧🇬Pleven, Bulgaria
Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
🇧🇬Ruse, Bulgaria
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Hvidovre Hospital, Lungemedicinsk Afdeling
🇩🇰Hvidovre, Denmark
SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia
🇷🇺Vladikavkaz, Russian Federation
City Hospital #40 of Resort Administrative District
🇷🇺St. Petersburg, Russian Federation
Fundacio Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Neumología
🇪🇸Cordoba, Spain
Synexus Magyarorszag Kft
🇭🇺Budapest, Hungary
Matrai Állami Gyógyintézet ; Bronchológia
🇭🇺Mátraháza, Hungary
Debrecen Uni Medical School; Dept of Pulmonary Medicine
🇭🇺Debrecen, Hungary
Waterbury Pulmonary Associates
🇺🇸Waterbury, Connecticut, United States
Southern California Research Center
🇺🇸Mission Viejo, California, United States
Asthma & Allergy Center, P.C.
🇺🇸Papillion, Nebraska, United States
AAADRS; Clinical Research Center
🇺🇸Coral Gables, Florida, United States
Allergy & Asthma Research of Nj, Inc
🇺🇸Mount Laurel, New Jersey, United States
Island Medical Research Pc
🇺🇸Commack, New York, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
🇺🇸New York, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Vital Prospects Clin Res Pc
🇺🇸Tulsa, Oklahoma, United States
Allergy-Asthma Specialists PC
🇺🇸Blue Bell, Pennsylvania, United States
Allergy Associates of Utah
🇺🇸Murray, Utah, United States
Northridge Internal Medicine
🇺🇸Charlottesville, Virginia, United States
Bridgerland Clinical Research
🇺🇸North Logan, Utah, United States
O & O Alpan, LLC
🇺🇸Fairfax, Virginia, United States
Hospital Erasme; Neurologie
🇧🇪Bruxelles, Belgium
Pulmonary & Sleep Research
🇺🇸Spokane, Washington, United States
Private Practice
🇧🇪Jambes, Belgium
CHU Sart-Tilman
🇧🇪Liège, Belgium
Inspiration Research Limited
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital; Endoscopy Department
🇨🇦Montreal, Quebec, Canada
Burlington Lung Clinic
🇨🇦Burlington, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montreal, Quebec, Canada
Hopital Laval; Centre de Pneumologie
🇨🇦Quebec, Canada
Lungemedicinsk afd. L, Bispebjerg Hospital
🇩🇰København NV, Denmark
Hopital Bichat Claude Bernard ; Service de Pneumologie
🇫🇷Paris, France
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
🇩🇪Bochum, Germany
Pneumologicum
🇩🇪Hannover, Germany
Institut für Allergie- und Asthmaforschung Berlin, IAAB
🇩🇪Berlin, Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
🇩🇪Essen, Germany
Universitätsklinikum Freiburg, Abteilung Pneumologie
🇩🇪Freiburg, Germany
Lungenzentrum Darmstadt
🇩🇪Darmstadt, Germany
KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt
🇩🇪Koblenz, Germany
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
🇩🇪München, Germany
Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio
🇮🇹Modena, Emilia-Romagna, Italy
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
🇩🇪Mainz, Germany
Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
🇭🇺Balassagyarmat, Hungary
Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás
🇭🇺Budapest, Hungary
AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia
🇮🇹Torino, Piemonte, Italy
Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
🇮🇹Catania, Sicilia, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
🇮🇹Pisa, Toscana, Italy
A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B
🇮🇹Palermo, Sicilia, Italy
Medisch Centrum Leeuwarden; Longziekten
🇳🇱Leeuwarden, Netherlands
Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
🇳🇱Hoofddorp, Netherlands
St. Antonius; R&D Long
🇳🇱Nieuwegein, Netherlands
FSBI "National Research Center - Institute of Immunology" of FMBA of Russia
🇷🇺Moscow, Russian Federation
Research Institute of Complex Cardiovascular Pathology
🇷🇺Kemerovo, Russian Federation
SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region
🇷🇺Krasnodar, Russian Federation
SBHI of NN region "RCH of NN n.a. N.A.Semashko"
🇷🇺Nizhny Novgorod, Russian Federation
SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology
🇷🇺Moscow, Russian Federation
Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
🇪🇸Majadahonda, Madrid, Spain
Saratov State Medical University; Chair Of Clinical Allergology
🇷🇺Saratov, Russian Federation
Hospital de Galdakano; Servicio de Neumologia
🇪🇸Galdakano, Vizcaya, Spain
Complexo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, LA Coruña, Spain
Hospital Clinic I provincial; Servicio de Neumologia
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre; Servicio de Neumologia
🇪🇸Madrid, Spain
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre
🇬🇧Newcastle upon Tyne, United Kingdom
William Harvey Research Institute
🇬🇧London, United Kingdom
North Manchester Hospital; Respiratory Department
🇬🇧Manchester, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, United Kingdom
Queen Alexandra Hospital, Portsmouth
🇬🇧Portsmouth, United Kingdom
CHVNG/E_Unidade 1; Servico de Pneumologia
🇵🇹Vila Nova De Gaia, Portugal
Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia
🇮🇹Chieti, Abruzzo, Italy
IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE
🇮🇹Genova, Liguria, Italy
Allergy & Asthma Res Ctr PA
🇺🇸San Antonio, Texas, United States
Clinical Research Center of Alabama, LLC
🇺🇸Birmingham, Alabama, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Allergy & Clinical Immun Assoc
🇺🇸Pittsburgh, Pennsylvania, United States
Capital Allergy Resp Dis Ctr
🇺🇸Sacramento, California, United States
Allergy Assoc Medical Group
🇺🇸San Diego, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
ASTHMA, Inc
🇺🇸Seattle, Washington, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States