A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

NCT ID: NCT01868061

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1068 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lebrikizumab (125 mg)

Participants will receive SC injection of lebrikizumab (125 mg) every 4 weeks for 104 weeks.

Group Type EXPERIMENTAL

Lebrikizumab

Intervention Type DRUG

Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

Lebrikizumab (37.5 mg)

Participants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks.

Group Type EXPERIMENTAL

Lebrikizumab

Intervention Type DRUG

Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

Placebo

Participants will receive SC injection of lebrikizumab matching placebo every 4 weeks for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at 125 or 37.5 mg for 52 weeks during active treatment extension period.

Group Type PLACEBO_COMPARATOR

Lebrikizumab

Intervention Type DRUG

Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

Placebo

Intervention Type DRUG

Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lebrikizumab

Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

Intervention Type DRUG

Placebo

Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RO5490255

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Asthma diagnosis for greater than equal to (\>/=) 12 months at Visit 1
* Bronchodilator response at Visit 1, 2, or 3
* Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
* On ICS therapy at a total daily dose of 500-2000 microgram (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for \>/= 6 months prior to Visit 1
* On an eligible second controller medication (long-acting Beta-agonist \[LABA\], leukotriene receptor antagonist \[LTRA\], long-acting muscarinic antagonist \[LAMA\], or theophylline) for 6 months prior to Visit 1
* Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
* Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease
* Demonstrated adherence with controller medication during the screening period

Exclusion Criteria

* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Maintenance oral corticosteroid therapy within 3 months of Visit 1
* Treatment with systemic (oral, intravenous \[IV\], or intramuscular \[IM\]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
* Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
* Infection requiring hospital admission for \>/=24 hours or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
* Active tuberculosis requiring treatment within 12 months prior to Visit 1
* Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
* Known current malignancy or current evaluation for potential malignancy
* Current smoker or former smoker with a history of greater than (\>) 10 pack-years
* History of alcohol or drug abuse
* Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
* Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Site Status

Medical Research of Arizona; Allergy, Asthma & Immu

Scottsdale, Arizona, United States

Site Status

Quality of Life Medical & Research Center

Tucson, Arizona, United States

Site Status

Kern Allergy Med Clinic, Inc.

Bakersfield, California, United States

Site Status

Allergy and Asthma Relief Experts

Granada Hills, California, United States

Site Status

Southern California Institute For Respiratory

Los Angeles, California, United States

Site Status

Allergy & Asthma Consultants

Redwood City, California, United States

Site Status

Integrated Research Group Inc

Upland, California, United States

Site Status

Allergy & Asthma Medical Group; Clinical Research Division

Walnut Creek, California, United States

Site Status

Asthma & Allergy; Associates, P.C.

Colorado Springs, Colorado, United States

Site Status

Storms Clinical Research; Institute

Colorado Springs, Colorado, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

Colorado Allergy & Asthma Centers, Pc

Denver, Colorado, United States

Site Status

Western States Clinical Research, Inc

Wheat Ridge, Colorado, United States

Site Status

Yale University School Of Medicine

New Haven, Connecticut, United States

Site Status

Allergy Consultants PA

Boca Raton, Florida, United States

Site Status

Research Institute of South Florida Inc

Miami, Florida, United States

Site Status

Sarasota Clinical Research

Sarasota, Florida, United States

Site Status

Georgia Pollens

Albany, Georgia, United States

Site Status

Brookstone Clinical Res Ctr

Columbus, Georgia, United States

Site Status

Southeast Regional Research Group

Columbus, Georgia, United States

Site Status

DataQuest Medical Research

Lawrenceville, Georgia, United States

Site Status

Aeroallergy Research Labs

Savannah, Georgia, United States

Site Status

Atlanta Allergy & Asthma Clini

Woodstock, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Asthma & Allergy of Idaho

Twin Falls, Idaho, United States

Site Status

The Allergy and Asthma Center

Fort Wayne, Indiana, United States

Site Status

Cotton O'Neil Clinic; Stormont-Vail Hlth Care

Topeka, Kansas, United States

Site Status

Dr. Paul Shapero

Bangor, Maine, United States

Site Status

Asthma, Allergy & Sinus Center

Baltimore, Maryland, United States

Site Status

Chesapeake Clinical Research

Baltimore, Maryland, United States

Site Status

Howard County Center for Lung and Sleep, LLC

Columbia, Maryland, United States

Site Status

Infinity Medical Research Inc

North Dartmouth, Massachusetts, United States

Site Status

Clinical Research Inst

Minneapolis, Minnesota, United States

Site Status

Asthma and Allergy Physicians LLC

Brockton, Mississippi, United States

Site Status

Allergy Associates, Inc.

Chesterfield, Missouri, United States

Site Status

Center For Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Clinical Research Center, L.L.C.

St Louis, Missouri, United States

Site Status

Clinical Research Consortium

Las Vegas, Nevada, United States

Site Status

Adult Pediatric Allergy Central Jersey

Edison, New Jersey, United States

Site Status

Patrick V. Perin, MD

Teaneck, New Jersey, United States

Site Status

University of New Mexico; School of Med

Albuquerque, New Mexico, United States

Site Status

Winthrop Univ Hospital

Mineola, New York, United States

Site Status

Allergy Partners of Western NC

Asheville, North Carolina, United States

Site Status

Allergy & Asthma Centre of Dayton

Centerville, Ohio, United States

Site Status

Integrity People Services Research Company

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Institute of Allergy and Asthma Clinical Research LLC

Oklahoma City, Oklahoma, United States

Site Status

Vital Prospects Clin Res Pc

Tulsa, Oklahoma, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Site Status

Asthma and Allergy Research Associates

Upland, Pennsylvania, United States

Site Status

Neem Research Group, Inc.

Columbia, South Carolina, United States

Site Status

Greenville Pharmaceutical Research

Greenville, South Carolina, United States

Site Status

Upstate Pharmaceutical Research; Greenville

Greenville, South Carolina, United States

Site Status

Future Search Clinical Trials L.P.

Austin, Texas, United States

Site Status

Elliot J. Ginchansky, MD, PA

Dallas, Texas, United States

Site Status

EPIMRD, Inc. DBA Western Sky Medical Research

El Paso, Texas, United States

Site Status

Baylor College of Medicine; Dept of Medicine

Houston, Texas, United States

Site Status

Allergy & Asthma Clin Cen TX

Round Rock, Texas, United States

Site Status

Quality Assurance Research Ctr

San Antonio, Texas, United States

Site Status

Discovery Clinical Trials

San Antonio, Texas, United States

Site Status

Allergy & Asthma Research Center

San Antonio, Texas, United States

Site Status

Live Oak Allergy & Asthma Clinic

San Antonio, Texas, United States

Site Status

Allergy Associates of Utah

Murray, Utah, United States

Site Status

Pulmonary Research of Albingdon

Abingdon, Virginia, United States

Site Status

University of Wisconsin;Allergy & Asthma Clinical Research

Madison, Wisconsin, United States

Site Status

Instituto de Investigaciones Clinicas-Mar del Plata

Buenos Aires, , Argentina

Site Status

Fundacion Cidea

Buenos Aires, , Argentina

Site Status

Centro Respiratorio Infantil

Rosario, , Argentina

Site Status

Centro Modelo de Cardiologia

San Miguel de Tucumán, , Argentina

Site Status

CEMER Centro Médico de Enfermedades Respiratorias

Vicente López, , Argentina

Site Status

Concord Repatriation General Hospital; Department Thoracic Medicine

Sydney, New South Wales, Australia

Site Status

AusTrials

Brisbane, Queensland, Australia

Site Status

Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

Brisbane, Queensland, Australia

Site Status

Respiratory Clinical Trials Pty Ltd

Toorak Gardens, South Australia, Australia

Site Status

The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Private Practice

Jambes, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

Rousse, , Bulgaria

Site Status

Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

Smolyan, , Bulgaria

Site Status

5TH MHAT; Pulmonology

Sofia, , Bulgaria

Site Status

National Multiprofile Hospital Tsar Boris III

Sofia, , Bulgaria

Site Status

Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases

Sofia, , Bulgaria

Site Status

SHATPD Sveta Sofia; Clin Pulmonary Diseases

Sofia, , Bulgaria

Site Status

Alitera - Med - Medical Center EOOD

Sofia, , Bulgaria

Site Status

Multiprofile Hospital For Active Treatment prof Kirkovich

Stara Zagora, , Bulgaria

Site Status

Diagnostic and Consulting Centre Mladost - M OOD

Varna, , Bulgaria

Site Status

Medical Center Tara OOD

Veliko Tarnovo, , Bulgaria

Site Status

Cheema Research, Inc

Mississauga, Ontario, Canada

Site Status

Ottawa Allergy Research Corp

Ottawa, Ontario, Canada

Site Status

Manna Research

Toronto, Ontario, Canada

Site Status

Dr Anil Dhar Professional Medicine Corporation

Windsor, Ontario, Canada

Site Status

Del Carpio Jaime Dr - Allergiste & Immunologue

Montreal, Quebec, Canada

Site Status

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status

Thomayerova nemocnice

Praha 4 - Krc, , Czechia

Site Status

Ordinace pro tuberkulozu a respiracni nemoci

Strakonice, , Czechia

Site Status

KASMED, s.r.o.; Alergologie a klinicka imunologie

Tábor, , Czechia

Site Status

Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Hôpital de La Croix Rousse

Lyon, , France

Site Status

Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon

Paris, , France

Site Status

Hopital Bichat Claude Bernard ; Service de Pneumologie

Paris, , France

Site Status

Medaimun GmbH

Frankfurt am Main, , Germany

Site Status

Pneumologisches Forschungsinstitut

Großhansdorf, , Germany

Site Status

Praxis Dr. med. Hermann A. Trauth

Marburg, , Germany

Site Status

Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

Debrecen, , Hungary

Site Status

Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés

Komárom, , Hungary

Site Status

Markusovszky Egyetemi Oktatokorhaz

Szombathely, , Hungary

Site Status

Rambam Health Care Campus

Haifa, , Israel

Site Status

Hadassah Medical Center; Pulmonary Institute

Jerusalem, , Israel

Site Status

Nazareth EMMS Hospital

Nazareth, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, , Israel

Site Status

Azienda Ospedaliera Monaldi

Napoli, Campania, Italy

Site Status

Azienda Ospedaliera Universitaria di Modena

Modena, Emilia-Romagna, Italy

Site Status

Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli

Rome, Lazio, Italy

Site Status

Asst Santi Paolo E Carlo

Milan, Lombardy, Italy

Site Status

Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria

Pavia, Lombardy, Italy

Site Status

P.O. Citta' Di Sesto S. Giovanni

Sesto San Giovanni, Lombardy, Italy

Site Status

Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

Catania, Sicily, Italy

Site Status

Banbuntane Hotokukai Hospital

Aichi, , Japan

Site Status

Fukuoka National Hospital

Fukuoka, , Japan

Site Status

Hiroshima Allegy & Respiratory Clinic

Hiroshima, , Japan

Site Status

Ibarakihigashi National Hospital

Ibaraki, , Japan

Site Status

Uno Naikakokyukika Clinic

Isesaki-shi, , Japan

Site Status

Yokohama City University Medical Center; Neurology

Kanagawa, , Japan

Site Status

Sagamihara National Hospital

Kanagawa, , Japan

Site Status

Kumamoto Saishunso National Hospital

Koshi-shi, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Kyoto University Hospital, Respiratory Medicine

Kyoto, , Japan

Site Status

Machida Municipal Hospital

Machida-shi, , Japan

Site Status

Hikarigaoka Spellman Hospital; Rheumatology

Miyagi, , Japan

Site Status

Nagoya Ekisaikai Hospital

Nagoya, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease

Osaka, , Japan

Site Status

Kinki University Hospital

Osaka, , Japan

Site Status

Kishiwada City Hospital

Osaka, , Japan

Site Status

Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

Sendai, , Japan

Site Status

Iwata City Hospital

Shizuoka, , Japan

Site Status

Takamatsu Municipal Hospital

Takamatsu, , Japan

Site Status

Hanzomon Hospital

Tokyo, , Japan

Site Status

Tokyo-Eki Center-building Clinic

Tokyo, , Japan

Site Status

Center Hospital of the National Center for Global Health and Medicine

Tokyo, , Japan

Site Status

Nihon University Itabashi Hospital

Tokyo, , Japan

Site Status

Toyama City Hospital

Toyama, , Japan

Site Status

Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

Guadalajara, , Mexico

Site Status

Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

Monterrey, , Mexico

Site Status

Consultorio Especialidad Alergologia Pediatrica

Villahermosa, , Mexico

Site Status

Greenlane Clinical Centre

Auckland, , New Zealand

Site Status

Canterbury Respiratory Research Group; Respiratory

Christchurch, , New Zealand

Site Status

P3 Research

Tauranga, , New Zealand

Site Status

Medical Research Inst. of New Zealand; Respiratory

Wellington, , New Zealand

Site Status

Hospital Nacional Adolfo; Guevara Velasco Essalud

Cusco, , Peru

Site Status

Hospital Nacional Luis N Saenz PNP

Lima, , Peru

Site Status

Clinica Internacional

Lima, , Peru

Site Status

ABK Reuma SRL- Medicentro BioCiencias

Lima, , Peru

Site Status

Centro de Investigación Ricardo Palma

Lima, , Peru

Site Status

Instituto Peruano de Investigacion en Ciencias Medicas

Lima, , Peru

Site Status

Clinica San Pablo

Lima, , Peru

Site Status

Clinica San Borja

Lima, , Peru

Site Status

Clinica los Andes

Miraflores, , Peru

Site Status

SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce

Bieńnkówka, , Poland

Site Status

GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

Krakow, , Poland

Site Status

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, , Poland

Site Status

Specjalistyczna Poradnia Pulmonologiczna

Ostrów Wielkopolski, , Poland

Site Status

Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic

Piła, , Poland

Site Status

ABC-PULMO Poradnia Chorob Pluc

Radom, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

Ruda Śląska, , Poland

Site Status

Centrum Medyczne Ogrodowa

Skierniewice, , Poland

Site Status

Alergo Medical Specjalistyczna Przychodnia Lekarska

Tarnów, , Poland

Site Status

Lexmedica

Wroclaw, , Poland

Site Status

Dobrostan Gabinety Lekarskie

Wroclaw, , Poland

Site Status

NZOZ Lekarze Specjalisci

Wroclaw, , Poland

Site Status

Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I

Cluj-Napoca, , Romania

Site Status

Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta

Palazu Mare, , Romania

Site Status

Targu Mures Clinical Emergency County Hospital

Târgu Mureş, , Romania

Site Status

Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

Timișoara, , Romania

Site Status

City Clinical Hospital #13

Moscow, , Russia

Site Status

I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF

Moscow, , Russia

Site Status

City Clinical Hospital #2

Novosibirsk, , Russia

Site Status

Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department

Penza, , Russia

Site Status

Ryazan Regional Clinincal Cardiology Dispensary

Ryazan, , Russia

Site Status

Municipal Polyclinic #25

Saint Petersburg, , Russia

Site Status

St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth

Saint Petersburg, , Russia

Site Status

St. Petersburg State Medical University n.a. I.P. Pavlov

Saint Petersburg, , Russia

Site Status

City Hospital #40 of Resort Administrative District

Saint Petersburg, , Russia

Site Status

Saratov State Medical Univ; Clinical Immun & Allerg

Saratov, , Russia

Site Status

Siberian State Medical University

Tomsk, , Russia

Site Status

Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital

Yaroslavl, , Russia

Site Status

Yaroslavl State Medical Academy - Clinical Hospital #2

Yaroslavl, , Russia

Site Status

Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Institute of Lung Diseases Vojvodina

Kamenitz, , Serbia

Site Status

Clinical Hospital Centre Zemun

Zemun, , Serbia

Site Status

Pneumo-Alergo Centrum s.r.o.

Bratislava, , Slovakia

Site Status

ZAPA JJ Sro

Levice, , Slovakia

Site Status

Imunoalergologia Dzurilla s.r.o.

Nitra, , Slovakia

Site Status

Respiratory Research Unit

Cape Town, , South Africa

Site Status

Tiervalei Trial Centre

Cape Town, , South Africa

Site Status

St Augustines Hospital; Infectoilogy

Durban, , South Africa

Site Status

Dr PJ Sebastian

Durban, , South Africa

Site Status

Aliwal Shoal Medical Center

eMkhomazi, , South Africa

Site Status

Limpopo Clinical Research Initiative; Tamboti Medical Centre

Tabazimbi, , South Africa

Site Status

Clinical Projects Research

Worcester, , South Africa

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Gyeonggi-do, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul St Mary's Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital; Division of Allergy and Clinical Immunology

Seoul, , South Korea

Site Status

Ewha Womans University Medical Center

Seoul, , South Korea

Site Status

Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo

Santiago de Compostela, La Coruña, Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

Majadahonda, Madrid, Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status

Instituto de Ciencias Medicas

Alicante, , Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Institut Catala de Serveis Medics

Girona, , Spain

Site Status

Hospital Universitario la Paz; Servicio de Alergologia

Madrid, , Spain

Site Status

Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases

Kyiv, Kiev Governorate, Ukraine

Site Status

Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , Ukraine

Site Status

MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council

Dnipropetrovsk, , Ukraine

Site Status

Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1

Donetsk, , Ukraine

Site Status

Municipal Institution of Health Care City Clinical Hospital #13

Kharkiv, , Ukraine

Site Status

SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine

Kharkiv, , Ukraine

Site Status

SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine

Kyiv, , Ukraine

Site Status

City Hospital #1

Mykolaiv, , Ukraine

Site Status

Municipal Institution Odesa Regional Clinical Hospital

Odesa, , Ukraine

Site Status

City Clinical Hospital No.1; Therap Ukr Med Stom Acad

Poltava, , Ukraine

Site Status

Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine

Vinnytsia, , Ukraine

Site Status

LLC Diaservis

Zaporizhzhia, , Ukraine

Site Status

Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9

Zaporizhzhye, , Ukraine

Site Status

Raigmore Hospital

Inverness, , United Kingdom

Site Status

Royal Preston Hospital

Preston, , United Kingdom

Site Status

Royal Hallamshire Hospital; Department of Oncology

Sheffield, , United Kingdom

Site Status

Southmead Hospital

Westbury-on-Trym, Bristol, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Bulgaria Canada Czechia France Germany Hungary Israel Italy Japan Mexico New Zealand Peru Poland Romania Russia Serbia Slovakia South Africa South Korea Spain Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.

Reference Type DERIVED
PMID: 33217063 (View on PubMed)

N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.

Reference Type DERIVED
PMID: 31803473 (View on PubMed)

Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.

Reference Type DERIVED
PMID: 27616196 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-000176-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GB28689

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.