Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: FP; Drug: LABA; Drug: LTRA; Drug: LAMA; Drug: Theophylline; Drug: Oral Corticosteroids

• Study Type: Interventional
• Enrollment (Actual): 483
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Hospital Erasme; Neurologie
  • Jambes, Belgium, 5100
    • Private Practice
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Mhat - Pleven; Clinic of Pulmonology
  • Ruse, Bulgaria, 7002
    • Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
• Canada
  • Quebec, Canada, G1V 4G5
    • Hopital Laval; Centre de Pneumologie
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L7
      • Vancouver General Hosp; The Lung Centre
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital University of British Colambia Division of Hematology
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • Burlington Lung Clinic
    • Kingston, Ontario, Canada, K7L 2V6
      • Kingston General Hospital
    • Toronto, Ontario, Canada, M5T 3A9
      • Inspiration Research Limited
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital; Endoscopy Department
• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital, Lungemedicinsk Afdeling
  • København NV, Denmark, 2400
    • Lungemedicinsk afd. L, Bispebjerg Hospital
• France
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard ; Service de Pneumologie
• Germany
  • Berlin, Germany, 12159
    • Institut für Allergie- und Asthmaforschung Berlin, IAAB
  • Bochum, Germany, 44789
    • Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
  • Darmstadt, Germany, 64283
    • Lungenzentrum Darmstadt
  • Essen, Germany, 45239
    • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg, Abteilung Pneumologie
  • Hannover, Germany, 30173
    • Pneumologicum
  • Koblenz, Germany, 56068
    • KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
  • München, Germany, 81377
    • Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft
  • Budapest, Hungary, 1122
    • Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás
  • Debrecen, Hungary, 4032
    • Debrecen Uni Medical School; Dept of Pulmonary Medicine
  • Mátraháza, Hungary, 3233
    • Matrai Állami Gyógyintézet ; Bronchológia
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41124
      • Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
    • Palermo, Sicilia, Italy, 90146
      • A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
• Latvia
  • Riga, Latvia, 1038
    • Clinical Hospital Gailezers; Dept of Pulmonology
  • Riga, Latvia, LV-1001
    • Riga 1st hospital, outpatient clinic Bruninieks
  • Riga, Latvia, LV-1011
    • Latvian University postgraduate institute
• Netherlands
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden; Longziekten
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius; R&D Long
• Portugal
  • Vila Nova De Gaia, Portugal, 4434-502
    • CHVNG/E_Unidade 1; Servico de Pneumologia
• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Research Institute of Complex Cardiovascular Pathology
  • Krasnodar, Russian Federation
    • SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region
  • Moscow, Russian Federation, 115478
    • FSBI "National Research Center - Institute of Immunology" of FMBA of Russia
  • Moscow, Russian Federation, 125993
    • SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology
  • Nizhny Novgorod, Russian Federation, 603126
    • SBHI of NN region "RCH of NN n.a. N.A.Semashko"
  • Saint-Petersburg, Russian Federation, 198328
    • City Out-patient Clinic #106
  • Saratov, Russian Federation, 410012
    • Saratov State Medical University; Chair Of Clinical Allergology
  • St. Petersburg, Russian Federation, 197706
    • City Hospital #40 of Resort Administrative District
  • Vladikavkaz, Russian Federation
    • SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia
• Spain
  • Barcelona, Spain, 08006
    • Fundacio Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinic I provincial; Servicio de Neumologia
  • Cordoba, Spain
    • Hospital Universitario Reina Sofia; Servicio de Neumología
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Neumologia
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Complexo Hospitalario Universitario De Santiago
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
  • Vizcaya
    • Galdakano, Vizcaya, Spain, 48960
      • Hospital de Galdakano; Servicio de Neumologia
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Royal Infirmary
  • Gloucester, United Kingdom, GL1 3NN
    • Gloucestershire Royal Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • London, United Kingdom, EC1M 6BQ
    • William Harvey Research Institute
  • Manchester, United Kingdom, M8 5RB
    • North Manchester Hospital; Respiratory Department
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital, Portsmouth
  • Shrewsbury, United Kingdom, SY3 8XQ
    • Royal Shrewsbury Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama, LLC
  • California
    • Mission Viejo, California, United States, 92691
      • Southern California Research Center
    • Sacramento, California, United States, 95819
      • Capital Allergy Resp Dis Ctr
    • San Diego, California, United States, 92108
      • Allergy Assoc Medical Group
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
    • Waterbury, Connecticut, United States, 06708
      • Waterbury Pulmonary Associates
  • Florida
    • Coral Gables, Florida, United States, 33134
      • AAADRS; Clinical Research Center
    • Port Charlotte, Florida, United States, 33952
      • Volunteer Medical Research
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens Clinical Research Centers
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • Asthma & Allergy Center, P.C.
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Allergy & Asthma Research of Nj, Inc
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Commack, New York, United States, 11725
      • Island Medical Research Pc
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10016
      • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clin Res Pc
  • Pennsylvania
    • Blue Bell, Pennsylvania, United States, 19422
      • Allergy-Asthma Specialists PC
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy & Clinical Immun Assoc
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks-Schuylkill Respiratory Specialists, Ltd
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78251
      • Allergy & Asthma Res Ctr PA
  • Utah
    • Murray, Utah, United States, 84107
      • Allergy Associates of Utah
    • North Logan, Utah, United States, 84341
      • Bridgerland Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Northridge Internal Medicine
    • Fairfax, Virginia, United States, 22030
      • O & O Alpan, LLC
  • Washington
    • Seattle, Washington, United States, 98105
      • ASTHMA, Inc
    • Spokane, Washington, United States, 99204
      • Pulmonary & Sleep Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Drug: FP; ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.; Drug: LABA; LABA will be administered as per investigator discretion.; Drug: LTRA; LTRA will be administered as per investigator discretion.; Drug: LAMA; LAMA will be administered as per investigator discretion.; Drug: Theophylline; Theophylline will be administered as per investigator discretion.; Drug: Oral Corticosteroids; Oral corticosteroids will be administered as per investigator discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2015
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Theophylline
• Other Study ID Numbers: MB29599; 2015-000742-35 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No