Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537691
• Other study ID #: MB29599
• Secondary ID: 2015-000742-35
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2015
• Est. completion date: July 10, 2017

Study information

• Verified date: April 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Hospital Erasme; Neurologie	Bruxelles
Belgium	Private Practice	Jambes
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHU Sart-Tilman	Liège
Belgium	CHU UCL Mont-Godinne	Mont-godinne
Bulgaria	Mhat - Pleven; Clinic of Pulmonology	Pleven
Bulgaria	Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases	Ruse
Canada	Burlington Lung Clinic	Burlington	Ontario
Canada	Kingston General Hospital	Kingston	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	Quebec
Canada	Inspiration Research Limited	Toronto	Ontario
Canada	St. Paul's Hospital University of British Colambia Division of Hematology	Vancouver	British Columbia
Canada	Vancouver General Hosp; The Lung Centre	Vancouver	British Columbia
Denmark	Hvidovre Hospital, Lungemedicinsk Afdeling	Hvidovre
Denmark	Lungemedicinsk afd. L, Bispebjerg Hospital	København NV
France	Hopital Bichat Claude Bernard ; Service de Pneumologie	Paris
Germany	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
Germany	Pneumologicum	Hannover
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
Hungary	Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )	Balassagyarmat
Hungary	Synexus Magyarorszag Kft	Budapest
Hungary	Szent János Kórház; Tüdogondozó Intézet és Szuroállomás	Budapest
Hungary	Debrecen Uni Medical School; Dept of Pulmonary Medicine	Debrecen
Hungary	Matrai Állami Gyógyintézet ; Bronchológia	Mátraháza
Italy	Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia	Catania	Sicilia
Italy	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	Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio	Modena	Emilia-Romagna
Italy	A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B	Palermo	Sicilia
Italy	A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii	Pisa	Toscana
Italy	AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia	Torino	Piemonte
Latvia	Clinical Hospital Gailezers; Dept of Pulmonology	Riga
Latvia	Latvian University postgraduate institute	Riga
Latvia	Riga 1st hospital, outpatient clinic Bruninieks	Riga
Netherlands	Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde	Hoofddorp
Netherlands	Medisch Centrum Leeuwarden; Longziekten	Leeuwarden
Netherlands	St. Antonius; R&D Long	Nieuwegein
Portugal	CHVNG/E_Unidade 1; Servico de Pneumologia	Vila Nova De Gaia
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	FSBI "National Research Center - Institute of Immunology" of FMBA of Russia	Moscow
Russian Federation	SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology	Moscow
Russian Federation	SBHI of NN region "RCH of NN n.a. N.A.Semashko"	Nizhny Novgorod
Russian Federation	City Out-patient Clinic #106	Saint-Petersburg
Russian Federation	Saratov State Medical University; Chair Of Clinical Allergology	Saratov
Russian Federation	City Hospital #40 of Resort Administrative District	St. Petersburg
Russian Federation	SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia	Vladikavkaz
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	Cordoba
Spain	Hospital de Galdakano; Servicio de Neumologia	Galdakano	Vizcaya
Spain	Hospital Universitario 12 de Octubre; Servicio de Neumologia	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología	Majadahonda	Madrid
Spain	Complexo Hospitalario Universitario de Santiago	Santiago de Compostela	LA Coruña
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	St George's Hospital	London
United Kingdom	William Harvey Research Institute	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 States	Georgia Pollens Clinical Research Centers	Albany	Georgia
United States	Clinical Research Center of Alabama, LLC	Birmingham	Alabama
United States	Allergy-Asthma Specialists PC	Blue Bell	Pennsylvania
United States	Montefiore Medical Center	Bronx	New York
United States	Northridge Internal Medicine	Charlottesville	Virginia
United States	Island Medical Research Pc	Commack	New York
United States	AAADRS; Clinical Research Center	Coral Gables	Florida
United States	O & O Alpan, LLC	Fairfax	Virginia
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	Winthrop University Hospital	Mineola	New York
United States	Southern California Research Center	Mission Viejo	California
United States	Allergy & Asthma Research of Nj, Inc	Mount Laurel	New Jersey
United States	Allergy Associates of Utah	Murray	Utah
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Laura and ISAAC Perlmutter Cancer Center at NYU Langone.	New York	New York
United States	Bridgerland Clinical Research	North Logan	Utah
United States	Asthma & Allergy Center, P.C.	Papillion	Nebraska
United States	Allergy & Clinical Immun Assoc	Pittsburgh	Pennsylvania
United States	Volunteer Medical Research	Port Charlotte	Florida
United States	Capital Allergy Resp Dis Ctr	Sacramento	California
United States	Allergy & Asthma Res Ctr PA	San Antonio	Texas
United States	Allergy Assoc Medical Group	San Diego	California
United States	ASTHMA, Inc	Seattle	Washington
United States	Pulmonary & Sleep Research	Spokane	Washington
United States	University of South Florida	Tampa	Florida
United States	Vital Prospects Clin Res Pc	Tulsa	Oklahoma
United States	Waterbury Pulmonary Associates	Waterbury	Connecticut
United States	Berks-Schuylkill Respiratory Specialists, Ltd	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Latvia,  Netherlands,  Portugal,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin		Baseline up to Week 52
Secondary	Percentage of Participants With Asthma Exacerbations		Baseline up to Week 52
Secondary	Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points		Baseline, Weeks 26, 52
Secondary	Time Taken for the Occurrence of First Asthma Exacerbation		Baseline up to Week 52
Secondary	Time to Treatment Failure		Baseline up to Week 52
Secondary	Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points		Baseline, Weeks 13, 26, 39, 52
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Serum Periostin Levels During the Study		Baseline, Weeks 26, 52
Secondary	Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels		Baseline, Weeks 26, 52
Secondary	Blood Eosinophil Levels During the Study		Baseline, Weeks 26, 52
Secondary	Serum Immunoglobulin E (IgE) Levels During the Study		Baseline, Weeks 26, 52
Secondary	Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations		Weeks 13, 26, 39, 52
Secondary	Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits		Weeks 13, 26, 39, 52
Secondary	Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits		Weeks 13, 26, 39, 52