Clinical trial NCT02537691: Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
Official title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Percentage of Participants With Asthma Exacerbations
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points
timeFrame: Baseline, Weeks 26, 52
measure: Time Taken for the Occurrence of First Asthma Exacerbation
timeFrame: Baseline up to Week 52
measure: Time to Treatment Failure
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points
timeFrame: Baseline, Weeks 13, 26, 39, 52
measure: Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points
timeFrame: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)
measure: Change From Baseline in Asthma Control Test (ACT) at Specified Time Points
timeFrame: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)
measure: Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee
timeFrame: Baseline up to Week 52
measure: Serum Periostin Levels During the Study
timeFrame: Baseline, Weeks 26, 52
measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
timeFrame: Baseline, Weeks 26, 52
measure: Blood Eosinophil Levels During the Study
timeFrame: Baseline, Weeks 26, 52
measure: Serum Immunoglobulin E (IgE) Levels During the Study
timeFrame: Baseline, Weeks 26, 52
measure: Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations
timeFrame: Weeks 13, 26, 39, 52
measure: Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits
timeFrame: Weeks 13, 26, 39, 52
measure: Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits
timeFrame: Weeks 13, 26, 39, 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Mission Viejo
country: United States
facility: Southern California Research Center
state: California
city: Sacramento
country: United States
facility: Capital Allergy Resp Dis Ctr
state: California
city: San Diego
country: United States
facility: Allergy Assoc Medical Group
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Waterbury
country: United States
facility: Waterbury Pulmonary Associates
state: Connecticut
city: Coral Gables
country: United States
facility: AAADRS; Clinical Research Center
state: Florida
city: Port Charlotte
country: United States
facility: Volunteer Medical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers
state: Georgia
city: Papillion
country: United States
facility: Asthma & Allergy Center, P.C.
state: Nebraska
city: Mount Laurel
country: United States
facility: Allergy & Asthma Research of Nj, Inc
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Commack
country: United States
facility: Island Medical Research Pc
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
state: New York
city: Tulsa
country: United States
facility: Vital Prospects Clin Res Pc
state: Oklahoma
city: Blue Bell
country: United States
facility: Allergy-Asthma Specialists PC
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immun Assoc
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks-Schuylkill Respiratory Specialists, Ltd
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Allergy & Asthma Res Ctr PA
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: North Logan
country: United States
facility: Bridgerland Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Northridge Internal Medicine
state: Virginia
city: Fairfax
country: United States
facility: O & O Alpan, LLC
state: Virginia
city: Seattle
country: United States
facility: ASTHMA, Inc
state: Washington
city: Spokane
country: United States
facility: Pulmonary & Sleep Research
state: Washington
city: Bruxelles
country: Belgium
facility: Hospital Erasme; Neurologie
city: Jambes
country: Belgium
facility: Private Practice
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Mont-godinne
country: Belgium
facility: CHU UCL Mont-Godinne
city: Pleven
country: Bulgaria
facility: Mhat - Pleven; Clinic of Pulmonology
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
city: Vancouver
country: Canada
facility: Vancouver General Hosp; The Lung Centre
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital University of British Colambia Division of Hematology
state: British Columbia
city: Burlington
country: Canada
facility: Burlington Lung Clinic
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Inspiration Research Limited
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital; Endoscopy Department
state: Quebec
city: Quebec
country: Canada
facility: Hopital Laval; Centre de Pneumologie
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Lungemedicinsk Afdeling
city: København NV
country: Denmark
facility: Lungemedicinsk afd. L, Bispebjerg Hospital
city: Paris
country: France
facility: Hopital Bichat Claude Bernard ; Service de Pneumologie
city: Berlin
country: Germany
facility: Institut für Allergie- und Asthmaforschung Berlin, IAAB
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
city: Darmstadt
country: Germany
facility: Lungenzentrum Darmstadt
city: Essen
country: Germany
facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Abteilung Pneumologie
city: Hannover
country: Germany
facility: Pneumologicum
city: Koblenz
country: Germany
facility: KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
city: München
country: Germany
facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft
city: Budapest
country: Hungary
facility: Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás
city: Debrecen
country: Hungary
facility: Debrecen Uni Medical School; Dept of Pulmonary Medicine
city: Mátraháza
country: Hungary
facility: Matrai Állami Gyógyintézet ; Bronchológia
city: Chieti
country: Italy
facility: Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia
state: Abruzzo
city: Modena
country: Italy
facility: Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio
state: Emilia-Romagna
city: Genova
country: Italy
facility: IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE
state: Liguria
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia
state: Piemonte
city: Catania
country: Italy
facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
state: Sicilia
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B
state: Sicilia
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
state: Toscana
city: Riga
country: Latvia
facility: Clinical Hospital Gailezers; Dept of Pulmonology
city: Riga
country: Latvia
facility: Riga 1st hospital, outpatient clinic Bruninieks
city: Riga
country: Latvia
facility: Latvian University postgraduate institute
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden; Longziekten
city: Nieuwegein
country: Netherlands
facility: St. Antonius; R&D Long
city: Vila Nova De Gaia
country: Portugal
facility: CHVNG/E_Unidade 1; Servico de Pneumologia
city: Kemerovo
country: Russian Federation
facility: Research Institute of Complex Cardiovascular Pathology
city: Krasnodar
country: Russian Federation
facility: SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region
city: Moscow
country: Russian Federation
facility: FSBI "National Research Center - Institute of Immunology" of FMBA of Russia
city: Moscow
country: Russian Federation
facility: SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology
city: Nizhny Novgorod
country: Russian Federation
facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"
city: Saint-Petersburg
country: Russian Federation
facility: City Out-patient Clinic #106
city: Saratov
country: Russian Federation
facility: Saratov State Medical University; Chair Of Clinical Allergology
city: St. Petersburg
country: Russian Federation
facility: City Hospital #40 of Resort Administrative District
city: Vladikavkaz
country: Russian Federation
facility: SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
state: LA Coruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
state: Madrid
city: Galdakano
country: Spain
facility: Hospital de Galdakano; Servicio de Neumologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Fundacio Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic I provincial; Servicio de Neumologia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Neumología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neumologia
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: London
country: United Kingdom
facility: William Harvey Research Institute
city: London
country: United Kingdom
facility: St George's Hospital
city: Manchester
country: United Kingdom
facility: North Manchester Hospital; Respiratory Department
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital, Portsmouth
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: