Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

NCT02537691 | Completed Phase 4

• 2 other identifiers: MB295992015-000742-35
• Study Type: interventional
• Target: 483
• Locations: 15 countries
• Sites: 100

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin

  Baseline up to Week 52

Secondary Outcomes (15)

• 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

Study Arms (1)

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.

Drug: FP; Drug: LABA; Drug: LTRA; Drug: LAMA; Drug: Theophylline; Drug: Oral Corticosteroids

Interventions

FP DRUG

ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.

Inhaled Corticosteroids (ICS) + Controller Medications

LABA DRUG

LABA will be administered as per investigator discretion.

Inhaled Corticosteroids (ICS) + Controller Medications

LTRA DRUG

LTRA will be administered as per investigator discretion.

Inhaled Corticosteroids (ICS) + Controller Medications

LAMA DRUG

LAMA will be administered as per investigator discretion.

Inhaled Corticosteroids (ICS) + Controller Medications

Theophylline DRUG

Theophylline will be administered as per investigator discretion.

Inhaled Corticosteroids (ICS) + Controller Medications

Oral Corticosteroids DRUG

Oral corticosteroids will be administered as per investigator discretion.

Inhaled Corticosteroids (ICS) + Controller Medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (100)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35209, United States

Location

Southern California Research Center

Mission Viejo, California, 92691, United States

Location

Capital Allergy Resp Dis Ctr

Sacramento, California, 95819, United States

Location

Allergy Assoc Medical Group

San Diego, California, 92108, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Waterbury Pulmonary Associates

Waterbury, Connecticut, 06708, United States

Location

AAADRS; Clinical Research Center

Coral Gables, Florida, 33134, United States

Location

Volunteer Medical Research

Port Charlotte, Florida, 33952, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Georgia Pollens Clinical Research Centers

Albany, Georgia, 31707, United States

Location

Asthma & Allergy Center, P.C.

Papillion, Nebraska, 68046, United States

Location

Allergy & Asthma Research of Nj, Inc

Mount Laurel, New Jersey, 08054, United States

Location

Island Medical Research Pc

Commack, New York, 11725, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Vital Prospects Clin Res Pc

Tulsa, Oklahoma, 74136, United States

Location

Allergy-Asthma Specialists PC

Blue Bell, Pennsylvania, 19422, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Allergy & Clinical Immun Assoc

Pittsburgh, Pennsylvania, 15241, United States

Location

Berks-Schuylkill Respiratory Specialists, Ltd

Wyomissing, Pennsylvania, 19610, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Allergy & Asthma Res Ctr PA

San Antonio, Texas, 78251, United States

Location

Allergy Associates of Utah

Murray, Utah, 84107, United States

Location

Bridgerland Clinical Research

North Logan, Utah, 84341, United States

Location

Northridge Internal Medicine

Charlottesville, Virginia, 22903, United States

Location

O & O Alpan, LLC

Fairfax, Virginia, 22030, United States

Location

ASTHMA, Inc

Seattle, Washington, 98105, United States

Location

Pulmonary & Sleep Research

Spokane, Washington, 99204, United States

Location

Hospital Erasme; Neurologie

Brussels, 1070, Belgium

Location

Private Practice

Jambes, 5100, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

CHU UCL Mont-Godinne

Mont-godinne, 5530, Belgium

Location

Mhat - Pleven; Clinic of Pulmonology

Pleven, 5800, Bulgaria

Location

Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

Rousse, 7002, Bulgaria

Location

Vancouver General Hosp; The Lung Centre

Vancouver, British Columbia, V5Z 1L7, Canada

Location

St. Paul's Hospital University of British Colambia Division of Hematology

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Burlington Lung Clinic

Burlington, Ontario, L7N 3V2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V6, Canada

Location

Inspiration Research Limited

Toronto, Ontario, M5T 3A9, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Jewish General Hospital; Endoscopy Department

Montreal, Quebec, H3T 1E2, Canada

Location

Hopital Laval; Centre de Pneumologie

Québec, G1V 4G5, Canada

Location

Hvidovre Hospital, Lungemedicinsk Afdeling

Hvidovre, 2650, Denmark

Location

Lungemedicinsk afd. L, Bispebjerg Hospital

København NV, 2400, Denmark

Location

Hopital Bichat Claude Bernard ; Service de Pneumologie

Paris, 75877, France

Location

Institut für Allergie- und Asthmaforschung Berlin, IAAB

Berlin, 12159, Germany

Location

Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

Bochum, 44789, Germany

Location

Lungenzentrum Darmstadt

Darmstadt, 64283, Germany

Location

Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

Essen, 45239, Germany

Location

Universitätsklinikum Freiburg, Abteilung Pneumologie

Freiburg im Breisgau, 79106, Germany

Location

Pneumologicum

Hanover, 30173, Germany

Location

KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt

Koblenz, 56068, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

Mainz, 55131, Germany

Location

Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

München, 81377, Germany

Location

Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )

Balassagyarmat, 2660, Hungary

Location

Synexus Magyarorszag Kft

Budapest, 1036, Hungary

Location

Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás

Budapest, 1122, Hungary

Location

Debrecen Uni Medical School; Dept of Pulmonary Medicine

Debrecen, 4032, Hungary

Location

Matrai Állami Gyógyintézet ; Bronchológia

Mátraháza, 3233, Hungary

Location

Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia

Chieti, Abruzzo, 66100, Italy

Location

Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio

Modena, Emilia-Romagna, 41124, Italy

Location

IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE

Genoa, Liguria, 16132, Italy

Location

AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia

Turin, Piedmont, 10126, Italy

Location

Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

Catania, Sicily, 95123, Italy

Location

A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B

Palermo, Sicily, 90146, Italy

Location

A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

Pisa, Tuscany, 56124, Italy

Location

Clinical Hospital Gailezers; Dept of Pulmonology

Riga, 1038, Latvia

Location

Riga 1st hospital, outpatient clinic Bruninieks

Riga, LV-1001, Latvia

Location

Latvian University postgraduate institute

Riga, LV-1011, Latvia

Location

Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

Hoofddorp, 2134 TM, Netherlands

Location

Medisch Centrum Leeuwarden; Longziekten

Leeuwarden, 8934 AD, Netherlands

Location

St. Antonius; R&D Long

Nieuwegein, 3435 CM, Netherlands

Location

CHVNG/E_Unidade 1; Servico de Pneumologia

Vila Nova de Gaia, 4434-502, Portugal

Location

Research Institute of Complex Cardiovascular Pathology

Kemerovo, 650002, Russia

Location

SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region

Krasnodar, Russia

Location

FSBI "National Research Center - Institute of Immunology" of FMBA of Russia

Moscow, 115478, Russia

Location

SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology

Moscow, 125993, Russia

Location

SBHI of NN region "RCH of NN n.a. N.A.Semashko"

Nizhny Novgorod, 603126, Russia

Location

City Hospital #40 of Resort Administrative District

Saint Petersburg, 197706, Russia

Location

City Out-patient Clinic #106

Saint Petersburg, 198328, Russia

Location

Saratov State Medical University; Chair Of Clinical Allergology

Saratov, 410012, Russia

Location

SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia

Vladikavkaz, Russia

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

Majadahonda, Madrid, 28222, Spain

Location

Hospital de Galdakano; Servicio de Neumologia

Galdakano, Vizcaya, 48960, Spain

Location

Fundacio Santa Creu I Sant Pau

Barcelona, 08006, Spain

Location

Hospital Clinic I provincial; Servicio de Neumologia

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Neumología

Córdoba, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Neumologia

Madrid, 28041, Spain

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, GL1 3NN, United Kingdom

Location

William Harvey Research Institute

London, EC1M 6BQ, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

North Manchester Hospital; Respiratory Department

Manchester, M8 5RB, United Kingdom

Location

Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Queen Alexandra Hospital, Portsmouth

Portsmouth, PO6 3LY, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, SY3 8XQ, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Theophylline; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 2, 2015
• Study Start: August 28, 2015
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

HU (5); NL (3); CA (8); FR (1); DE (9); ES (7); GB (9); DK (2); BU (2); US (29); BE (5); LA (3); PT (1); RU (9); IT (7)