Back to resultsLongitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
FP
LABA
LTRA
LAMA
Theophylline
Oral Corticosteroids
Sponsored by
About this trial
This is an interventional health services research trial for Asthma
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
Sites / Locations
- Clinical Research Center of Alabama, LLC
- Southern California Research Center
- Capital Allergy Resp Dis Ctr
- Allergy Assoc Medical Group
- Yale New Haven Hospital
- Waterbury Pulmonary Associates
- AAADRS; Clinical Research Center
- Volunteer Medical Research
- University of South Florida
- Georgia Pollens Clinical Research Centers
- Asthma & Allergy Center, P.C.
- Allergy & Asthma Research of Nj, Inc
- Montefiore Medical Center
- Island Medical Research Pc
- Winthrop University Hospital
- Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
- Vital Prospects Clin Res Pc
- Allergy-Asthma Specialists PC
- Penn State Milton S. Hershey Medical Center
- Allergy & Clinical Immun Assoc
- Berks-Schuylkill Respiratory Specialists, Ltd
- Baylor College of Medicine
- Allergy & Asthma Res Ctr PA
- Allergy Associates of Utah
- Bridgerland Clinical Research
- Northridge Internal Medicine
- O & O Alpan, LLC
- ASTHMA, Inc
- Pulmonary & Sleep Research
- Hospital Erasme; Neurologie
- Private Practice
- UZ Leuven Gasthuisberg
- CHU Sart-Tilman
- CHU UCL Mont-Godinne
- Mhat - Pleven; Clinic of Pulmonology
- Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
- Vancouver General Hosp; The Lung Centre
- St. Paul's Hospital University of British Colambia Division of Hematology
- Burlington Lung Clinic
- Kingston General Hospital
- Inspiration Research Limited
- Centre Hospitalier de l'Université de Montréal (CHUM)
- Jewish General Hospital; Endoscopy Department
- Hopital Laval; Centre de Pneumologie
- Hvidovre Hospital, Lungemedicinsk Afdeling
- Lungemedicinsk afd. L, Bispebjerg Hospital
- Hopital Bichat Claude Bernard ; Service de Pneumologie
- Institut für Allergie- und Asthmaforschung Berlin, IAAB
- Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
- Lungenzentrum Darmstadt
- Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
- Universitätsklinikum Freiburg, Abteilung Pneumologie
- Pneumologicum
- KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
- Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
- Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
- Synexus Magyarorszag Kft
- Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás
- Debrecen Uni Medical School; Dept of Pulmonary Medicine
- Matrai Állami Gyógyintézet ; Bronchológia
- Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia
- Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio
- IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE
- AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia
- Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
- A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B
- A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
- Clinical Hospital Gailezers; Dept of Pulmonology
- Riga 1st hospital, outpatient clinic Bruninieks
- Latvian University postgraduate institute
- Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
- Medisch Centrum Leeuwarden; Longziekten
- St. Antonius; R&D Long
- CHVNG/E_Unidade 1; Servico de Pneumologia
- Research Institute of Complex Cardiovascular Pathology
- SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region
- FSBI "National Research Center - Institute of Immunology" of FMBA of Russia
- SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology
- SBHI of NN region "RCH of NN n.a. N.A.Semashko"
- City Out-patient Clinic #106
- Saratov State Medical University; Chair Of Clinical Allergology
- City Hospital #40 of Resort Administrative District
- SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia
- Complexo Hospitalario Universitario de Santiago
- Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
- Hospital de Galdakano; Servicio de Neumologia
- Fundacio Santa Creu I Sant Pau
- Hospital Clinic I provincial; Servicio de Neumologia
- Hospital Universitario Reina Sofia; Servicio de Neumología
- Hospital Universitario 12 de Octubre; Servicio de Neumologia
- Queen Elizabeth Hospital
- Bradford Royal Infirmary
- Gloucestershire Royal Hospital
- William Harvey Research Institute
- St George's Hospital
- North Manchester Hospital; Respiratory Department
- Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre
- Queen Alexandra Hospital, Portsmouth
- Royal Shrewsbury Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Inhaled Corticosteroids (ICS) + Controller Medications
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin
Secondary Outcome Measures
Percentage of Participants With Asthma Exacerbations
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points
Time Taken for the Occurrence of First Asthma Exacerbation
Time to Treatment Failure
Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points
Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points
Change From Baseline in Asthma Control Test (ACT) at Specified Time Points
Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee
Serum Periostin Levels During the Study
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
Blood Eosinophil Levels During the Study
Serum Immunoglobulin E (IgE) Levels During the Study
Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations
Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits
Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02537691
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 28, 2015 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
483 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaled Corticosteroids (ICS) + Controller Medications
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FP
Intervention Description
ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.
Intervention Type
Drug
Intervention Name(s)
LABA
Intervention Description
LABA will be administered as per investigator discretion.
Intervention Type
Drug
Intervention Name(s)
LTRA
Intervention Description
LTRA will be administered as per investigator discretion.
Intervention Type
Drug
Intervention Name(s)
LAMA
Intervention Description
LAMA will be administered as per investigator discretion.
Intervention Type
Drug
Intervention Name(s)
Theophylline
Intervention Description
Theophylline will be administered as per investigator discretion.
Intervention Type
Drug
Intervention Name(s)
Oral Corticosteroids
Intervention Description
Oral corticosteroids will be administered as per investigator discretion.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With Asthma Exacerbations
Time Frame
Baseline up to Week 52
Title
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points
Time Frame
Baseline, Weeks 26, 52
Title
Time Taken for the Occurrence of First Asthma Exacerbation
Time Frame
Baseline up to Week 52
Title
Time to Treatment Failure
Time Frame
Baseline up to Week 52
Title
Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points
Time Frame
Baseline, Weeks 13, 26, 39, 52
Title
Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points
Time Frame
Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)
Title
Change From Baseline in Asthma Control Test (ACT) at Specified Time Points
Time Frame
Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)
Title
Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee
Time Frame
Baseline up to Week 52
Title
Serum Periostin Levels During the Study
Time Frame
Baseline, Weeks 26, 52
Title
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
Time Frame
Baseline, Weeks 26, 52
Title
Blood Eosinophil Levels During the Study
Time Frame
Baseline, Weeks 26, 52
Title
Serum Immunoglobulin E (IgE) Levels During the Study
Time Frame
Baseline, Weeks 26, 52
Title
Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations
Time Frame
Weeks 13, 26, 39, 52
Title
Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits
Time Frame
Weeks 13, 26, 39, 52
Title
Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits
Time Frame
Weeks 13, 26, 39, 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Southern California Research Center
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Capital Allergy Resp Dis Ctr
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Allergy Assoc Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Waterbury Pulmonary Associates
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
AAADRS; Clinical Research Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Volunteer Medical Research
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Asthma & Allergy Center, P.C.
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Allergy & Asthma Research of Nj, Inc
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Island Medical Research Pc
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Vital Prospects Clin Res Pc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Allergy-Asthma Specialists PC
City
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Allergy & Clinical Immun Assoc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Berks-Schuylkill Respiratory Specialists, Ltd
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Allergy & Asthma Res Ctr PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
Allergy Associates of Utah
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Bridgerland Clinical Research
City
North Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Northridge Internal Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
O & O Alpan, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
ASTHMA, Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Pulmonary & Sleep Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Hospital Erasme; Neurologie
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Private Practice
City
Jambes
ZIP/Postal Code
5100
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Mont-Godinne
City
Mont-godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Mhat - Pleven; Clinic of Pulmonology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Vancouver General Hosp; The Lung Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
Facility Name
St. Paul's Hospital University of British Colambia Division of Hematology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Burlington Lung Clinic
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V6
Country
Canada
Facility Name
Inspiration Research Limited
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Jewish General Hospital; Endoscopy Department
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital Laval; Centre de Pneumologie
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Hvidovre Hospital, Lungemedicinsk Afdeling
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Lungemedicinsk afd. L, Bispebjerg Hospital
City
København NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Hopital Bichat Claude Bernard ; Service de Pneumologie
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Institut für Allergie- und Asthmaforschung Berlin, IAAB
City
Berlin
ZIP/Postal Code
12159
Country
Germany
Facility Name
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Lungenzentrum Darmstadt
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Abteilung Pneumologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Pneumologicum
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Synexus Magyarorszag Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debrecen Uni Medical School; Dept of Pulmonary Medicine
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Matrai Állami Gyógyintézet ; Bronchológia
City
Mátraháza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Facility Name
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
Clinical Hospital Gailezers; Dept of Pulmonology
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Riga 1st hospital, outpatient clinic Bruninieks
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Latvian University postgraduate institute
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
Facility Name
Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden; Longziekten
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
St. Antonius; R&D Long
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
CHVNG/E_Unidade 1; Servico de Pneumologia
City
Vila Nova De Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Research Institute of Complex Cardiovascular Pathology
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region
City
Krasnodar
Country
Russian Federation
Facility Name
FSBI "National Research Center - Institute of Immunology" of FMBA of Russia
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology
City
Moscow
ZIP/Postal Code
125993
Country
Russian Federation
Facility Name
SBHI of NN region "RCH of NN n.a. N.A.Semashko"
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
City Out-patient Clinic #106
City
Saint-Petersburg
ZIP/Postal Code
198328
Country
Russian Federation
Facility Name
Saratov State Medical University; Chair Of Clinical Allergology
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
City Hospital #40 of Resort Administrative District
City
St. Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia
City
Vladikavkaz
Country
Russian Federation
Facility Name
Complexo Hospitalario Universitario de Santiago
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital de Galdakano; Servicio de Neumologia
City
Galdakano
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Facility Name
Fundacio Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Clinic I provincial; Servicio de Neumologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Neumología
City
Cordoba
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neumologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
William Harvey Research Institute
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
North Manchester Hospital; Respiratory Department
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Queen Alexandra Hospital, Portsmouth
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
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