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AsthmaPhase 4NCT02537691

Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

A Phase 4 study testing FP, LABA and LTRA in people with Asthma, run by Hoffmann-La Roche at 100 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
FP, LABA and LTRA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
483 participants
Where
100 sitesin 15 countries
Study dates
28 Aug 2015to 10 Jul 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

100 sites in 15 countries.

100 sites in 15 countries

United States29 sites

  • Georgia Pollens Clinical Research Centers

    Albany, Georgia, 31707

  • Clinical Research Center of Alabama, LLC

    Birmingham, Alabama, 35209

  • Allergy-Asthma Specialists PC

    Blue Bell, Pennsylvania, 19422

  • Northridge Internal Medicine

    Charlottesville, Virginia, 22903

  • Island Medical Research Pc

    Commack, New York, 11725

  • AAADRS; Clinical Research Center

    Coral Gables, Florida, 33134

  • O & O Alpan, LLC

    Fairfax, Virginia, 22030

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Southern California Research Center

    Mission Viejo, California, 92691

  • Allergy & Asthma Research of Nj, Inc

    Mount Laurel, New Jersey, 08054

  • Allergy Associates of Utah

    Murray, Utah, 84107

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York, 10016

  • Bridgerland Clinical Research

    North Logan, Utah, 84341

  • Asthma & Allergy Center, P.C.

    Papillion, Nebraska, 68046

  • Allergy & Clinical Immun Assoc

    Pittsburgh, Pennsylvania, 15241

  • Volunteer Medical Research

    Port Charlotte, Florida, 33952

  • Capital Allergy Resp Dis Ctr

    Sacramento, California, 95819

  • Allergy & Asthma Res Ctr PA

    San Antonio, Texas, 78251

  • Allergy Assoc Medical Group

    San Diego, California, 92108

  • ASTHMA, Inc

    Seattle, Washington, 98105

  • Pulmonary & Sleep Research

    Spokane, Washington, 99204

  • University of South Florida

    Tampa, Florida, 33613

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Vital Prospects Clin Res Pc

    Tulsa, Oklahoma, 74136

  • Waterbury Pulmonary Associates

    Waterbury, Connecticut, 06708

  • Berks-Schuylkill Respiratory Specialists, Ltd

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Germany9 sites

  • Institut für Allergie- und Asthmaforschung Berlin, IAAB

    Berlin, 12159

  • Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

    Bochum, 44789

  • Lungenzentrum Darmstadt

    Darmstadt, 64283

  • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

    Essen, 45239

  • Universitätsklinikum Freiburg, Abteilung Pneumologie

    Freiburg im Breisgau, 79106

  • Pneumologicum

    Hanover, 30173

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

    Koblenz, 56068

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

    Mainz, 55131

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

    München, 81377

Other trials in Germany

Russia9 sites

  • Research Institute of Complex Cardiovascular Pathology

    Kemerovo, 650002

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

    Krasnodar

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

    Moscow, 115478

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

    Moscow, 125993

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

    Nizhny Novgorod, 603126

  • City Hospital #40 of Resort Administrative District

    Saint Petersburg, 197706

  • City Out-patient Clinic #106

    Saint Petersburg, 198328

  • Saratov State Medical University; Chair Of Clinical Allergology

    Saratov, 410012

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

    Vladikavkaz

Other trials in Russia

United Kingdom9 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • William Harvey Research Institute

    London, EC1M 6BQ

  • St George's Hospital

    London, SW17 0QT

  • North Manchester Hospital; Respiratory Department

    Manchester, M8 5RB

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

    Newcastle upon Tyne, NE7 7DN

  • Queen Alexandra Hospital, Portsmouth

    Portsmouth, PO6 3LY

  • Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ

Other trials in United Kingdom

Canada8 sites

  • Burlington Lung Clinic

    Burlington, Ontario, L7N 3V2

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V6

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital; Endoscopy Department

    Montreal, Quebec, H3T 1E2

  • Hopital Laval; Centre de Pneumologie

    Québec, G1V 4G5

  • Inspiration Research Limited

    Toronto, Ontario, M5T 3A9

  • Vancouver General Hosp; The Lung Centre

    Vancouver, British Columbia, V5Z 1L7

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

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Italy7 sites

  • Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

    Catania, Sicily, 95123

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

    Chieti, Abruzzo, 66100

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

    Genoa, Liguria, 16132

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

    Modena, Emilia-Romagna, 41124

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

    Palermo, Sicily, 90146

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

    Pisa, Tuscany, 56124

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

    Turin, Piedmont, 10126

Other trials in Italy

Spain7 sites

  • Fundacio Santa Creu I Sant Pau

    Barcelona, 08006

  • Hospital Clinic I provincial; Servicio de Neumologia

    Barcelona, 08036

  • Hospital Universitario Reina Sofia; Servicio de Neumología

    Córdoba

  • Hospital de Galdakano; Servicio de Neumologia

    Galdakano, Vizcaya, 48960

  • Hospital Universitario 12 de Octubre; Servicio de Neumologia

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

    Majadahonda, Madrid, 28222

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, LA Coruña, 15706

Other trials in Spain

Belgium5 sites

  • Hospital Erasme; Neurologie

    Brussels, 1070

  • Private Practice

    Jambes, 5100

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU Sart-Tilman

    Liège, 4000

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530

Other trials in Belgium

Hungary5 sites

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

    Balassagyarmat, 2660

  • Synexus Magyarorszag Kft

    Budapest, 1036

  • Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás

    Budapest, 1122

  • Debrecen Uni Medical School; Dept of Pulmonary Medicine

    Debrecen, 4032

  • Matrai Állami Gyógyintézet ; Bronchológia

    Mátraháza, 3233

Other trials in Hungary

Latvia3 sites

  • Clinical Hospital Gailezers; Dept of Pulmonology

    Riga, 1038

  • Riga 1st hospital, outpatient clinic Bruninieks

    Riga, LV-1001

  • Latvian University postgraduate institute

    Riga, LV-1011

Other trials in Latvia

Netherlands3 sites

  • Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

    Hoofddorp, 2134 TM

  • Medisch Centrum Leeuwarden; Longziekten

    Leeuwarden, 8934 AD

  • St. Antonius; R&D Long

    Nieuwegein, 3435 CM

Other trials in Netherlands

Bulgaria2 sites

  • Mhat - Pleven; Clinic of Pulmonology

    Pleven, 5800

  • Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

    Rousse, 7002

Other trials in Bulgaria

Denmark2 sites

  • Hvidovre Hospital, Lungemedicinsk Afdeling

    Hvidovre, 2650

  • Lungemedicinsk afd. L, Bispebjerg Hospital

    København NV, 2400

Other trials in Denmark

France1 site

  • Hopital Bichat Claude Bernard ; Service de Pneumologie

    Paris, 75877

Other trials in France

Portugal1 site

  • CHVNG/E_Unidade 1; Servico de Pneumologia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

About this study

Official title: 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.

Conditions
Asthma
Being tested
FP, LABA, LTRA, LAMA, Theophylline
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FPDrug

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

  • LABADrug

    LABA will be administered as per investigator discretion.

  • LTRADrug

    LTRA will be administered as per investigator discretion.

  • LAMADrug

    LAMA will be administered as per investigator discretion.

  • TheophyllineDrug

    Theophylline will be administered as per investigator discretion.

  • Oral CorticosteroidsDrug

    Oral corticosteroids will be administered as per investigator discretion.

Study groups in NCT02537691
Study groupRoleWhat they receive
Inhaled Corticosteroids (ICS) + Controller MedicationsOtherParticipants 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.
Receives: Drug: FP; Drug: LABA; Drug: LTRA; Drug: LAMA; Drug: Theophylline; Drug: Oral Corticosteroids

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline up to Week 52

Secondary outcomes (15)

  1. Percentage of Participants With Asthma Exacerbations

    Measured: Baseline up to Week 52

  2. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points

    Measured: Baseline, Weeks 26, 52

  3. Time Taken for the Occurrence of First Asthma Exacerbation

    Measured: Baseline up to Week 52

  4. Time to Treatment Failure

    Measured: Baseline up to Week 52

  5. Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points

    Measured: Baseline, Weeks 13, 26, 39, 52

  6. Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points

    Measured: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)

  7. Change From Baseline in Asthma Control Test (ACT) at Specified Time Points

    Measured: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)

  8. Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee

    Measured: Baseline up to Week 52

  9. Serum Periostin Levels During the Study

    Measured: Baseline, Weeks 26, 52

  10. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels

    Measured: Baseline, Weeks 26, 52

  11. Blood Eosinophil Levels During the Study

    Measured: Baseline, Weeks 26, 52

  12. Serum Immunoglobulin E (IgE) Levels During the Study

    Measured: Baseline, Weeks 26, 52

  13. Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations

    Measured: Weeks 13, 26, 39, 52

  14. Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits

    Measured: Weeks 13, 26, 39, 52

  15. Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits

    Measured: Weeks 13, 26, 39, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2015 (estimated)
  2. Study start28 Aug 2015
  3. Primary completion10 Jul 2017
  4. Study completion10 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
483 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02537691
Sponsor's protocol ID
MB29599
Other IDs
2015-000742-35, 2015
Status last verified
Apr 2019
First submitted
27 Aug 2015
Last updated
9 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FP, LABA and LTRA in people with Asthma, run by Hoffmann-La Roche at 100 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Germany, Russia, United Kingdom, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin (time frame: Baseline up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02537691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.

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