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

NCT ID: NCT01867125

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

1081 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 subcutaneously (SC) 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 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 milligrams \[mg\]) 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

Intervention Type DRUG

Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 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 prior to 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 micrograms (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 infection that required treatment with oral antibiotics within 2 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.

Alabama Clinical Research Associates

Pell City, Alabama, United States

Site Status

Clinical Trial Connection

Flagstaff, Arizona, United States

Site Status

Desert Sun Clinical Research LLC

Tucson, Arizona, United States

Site Status

Allianz Medical and Research Center

Fountain Valley, California, United States

Site Status

Allergy & Asthma Medical Group & Research Center, Pc

Long Beach, California, United States

Site Status

Alliance Research LLC

Long Beach, California, United States

Site Status

Allergy Medical Clinic

Los Angeles, California, United States

Site Status

CA Allergy & Asthma Med Grp

Los Angeles, California, United States

Site Status

North Bay Clinical Trials

Napa, California, United States

Site Status

Choc Psf, Amc

Orange, California, United States

Site Status

Advances in Medicine

Rancho Mirage, California, United States

Site Status

Allergy Assoc Medical Group

San Diego, California, United States

Site Status

UCSF School of Medicine

San Francisco, California, United States

Site Status

Bensch Research Associates

Stockton, California, United States

Site Status

IMMUNOe International Research Centers

Centennial, Colorado, United States

Site Status

Waterbury Pulmonary Associates

Waterbury, Connecticut, United States

Site Status

St. Francis Sleep; Allergy & Lung Institute

Clearwater, Florida, United States

Site Status

Creekside Medical Research

DeLand, Florida, United States

Site Status

Suncoast Research Group LLC

Miami, Florida, United States

Site Status

South Florida Research Phase I-IV, Inc

Miami, Florida, United States

Site Status

Allergy & Asthma Care of FL; Clinical Research

Ocala, Florida, United States

Site Status

Emerald Coast Research Associates

Panama City, Florida, United States

Site Status

Allergy & Asthma Diagnostic; Treatment Center

Tallahassee, Florida, United States

Site Status

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, United States

Site Status

Southeastern Lung Care

Decatur, Georgia, United States

Site Status

Atlanta Allergy & Asthma Clini

Woodstock, Georgia, United States

Site Status

Laporte County Institute For Clinical Research

Michigan City, Indiana, United States

Site Status

Iowa Clinical Research Corporation

Iowa City, Iowa, United States

Site Status

Northeast Medical Research Associates, Inc

North Dartmouth, Massachusetts, United States

Site Status

Infusion Associates

Grand Rapids, Michigan, United States

Site Status

Midwest Clinical Research LLC

St Louis, Missouri, United States

Site Status

Washington Univ. School of Med

St Louis, Missouri, United States

Site Status

Montana Medical Research LLC

Missoula, Montana, United States

Site Status

Heartland Clinical Research Inc.

Omaha, Nebraska, United States

Site Status

Asthma & Allergy Center, P.C.

Papillion, Nebraska, United States

Site Status

Allergy & Asthma Associates

Las Vegas, Nevada, United States

Site Status

Allergy & Asthma Research of Nj, Inc

Mount Laurel, New Jersey, United States

Site Status

Atlantic Research Center, LLC

Ocean City, New Jersey, United States

Site Status

Princeton Center For Clinical Research

Skillman, New Jersey, United States

Site Status

North Shore University Hosp

New Hyde Park, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Allergy & Asthma Center of NC

High Point, North Carolina, United States

Site Status

PMG Research of Wilmington

Wilmington, North Carolina, United States

Site Status

Asthma & Allergy Center

Toledo, Ohio, United States

Site Status

Cor Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Allergy & Asthma Research Grp

Eugene, Oregon, United States

Site Status

Clinical Research Inst. of Southern Oregon, Pc

Medford, Oregon, United States

Site Status

Allergy Associates Research Center

Portland, Oregon, United States

Site Status

Central PA Asth & Allergy Care; Research Division

Altoona, Pennsylvania, United States

Site Status

Asthma Allergy Pulm Associates

Philadelphia, Pennsylvania, United States

Site Status

Grand View Hospital; Clinical Research Department

Sellersville, Pennsylvania, United States

Site Status

Asthma Allergy Phys of RI

Lincoln, Rhode Island, United States

Site Status

ADAC Research PA

Greenville, South Carolina, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Tekton Research Inc

Austin, Texas, United States

Site Status

TTS Research

Boerne, Texas, United States

Site Status

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, United States

Site Status

Allergy & Asthma Research Center of El Paso

El Paso, Texas, United States

Site Status

Pioneer Research Solutions

Houston, Texas, United States

Site Status

Metroplex Pulmonology & Sleep Center

McKinney, Texas, United States

Site Status

Quality Assurance Research Ctr

San Antonio, Texas, United States

Site Status

O & O Alpan, LLC

Fairfax, Virginia, United States

Site Status

Clinical Research Partners, LLC

Henrico, Virginia, United States

Site Status

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status

Bellingham Asthma, Allergy & Immunology

Bellingham, Washington, United States

Site Status

ASTHMA, Inc

Seattle, Washington, United States

Site Status

Marycliff Allergy Specialists

Spokane, Washington, United States

Site Status

Dean Clinic

Madison, Wisconsin, United States

Site Status

Fundación Faicep

Buenos Aires, , Argentina

Site Status

Centro Médico Dra de Salvo

Buenos Aires, , Argentina

Site Status

Instituto Ave Pulmo

Mar del Plata, , Argentina

Site Status

Centro Respiratorio Quilmes

Quilmes, , Argentina

Site Status

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, , Argentina

Site Status

Liverpool Hospital

Liverpool BC, New South Wales, Australia

Site Status

St. Vincent's Hospital Melbourne

Fitzroy, South Australia, Australia

Site Status

Box Hill Hospital; Eastern Clinical Research Unit

Box Hill, Victoria, Australia

Site Status

Western Hospital

Footscray, Victoria, Australia

Site Status

The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

Alberta Health Services

Calgary, Alberta, Canada

Site Status

Dr. E. Amer

Mississauga, Ontario, Canada

Site Status

Inspiration Research Limited

Toronto, Ontario, Canada

Site Status

Albion Finch Medical Centre

Toronto, Ontario, Canada

Site Status

Centre d'investigation Clinique Mauricie

Trois-Rivières, Quebec, Canada

Site Status

Centro de Investigaciones Medicas Respiratorias

Santiago, , Chile

Site Status

Schonffeldt y Guerrero Limitada

Santiago, , Chile

Site Status

Hospital Carlos Van Buren

Valparaíso, , Chile

Site Status

Fundacion Neumologica Colombiana

Bogota DC, , Colombia

Site Status

Alergopraktik s.r.o.

Jablonec nad Nisou, , Czechia

Site Status

Interni A Pneumologicka Ambulance

Jindřichův Hradec, , Czechia

Site Status

MephaCentrum, a.s.

Ostrava - Poruba, , Czechia

Site Status

Alergologie Teplice, s.r.o.

Teplice, , Czechia

Site Status

Hopital Calmette; Pneumologie

Lille, , France

Site Status

Hopital Nord; CIC

Marseille, , France

Site Status

Hôpital Arnaud de Villeneuve

Montpellier, , France

Site Status

CHU Nantes - Hôpital Laennec; Service de Pneumologie

Nantes, , France

Site Status

Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

Strabourg, , France

Site Status

Lungenarztpraxis Tegel

Berlin, , Germany

Site Status

Pneumologisches Zentrum Wiesloch

Wiesloch, , Germany

Site Status

Kenezy Korhaz Rendelointezet

Debrecen, , Hungary

Site Status

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Site Status

C.C.C. Hospital Chest Diseases

Szeged, , Hungary

Site Status

Barzilai Medical Center; Pulmonary Inst.

Ashkelon, , Israel

Site Status

Lady Davis Carmel Medical Center; Cardiovascular Medicine

Haifa, , Israel

Site Status

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Meir Medical Center; Pulmonary Dept

Kfar Saba, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia

Cassano Murge (BA), Apulia, Italy

Site Status

University of Catanzaro

Catanzaro, Calabria, Italy

Site Status

Azienda Ospedaliero Universitaria di Parma

Parma, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

Torrette - Ancona, The Marches, Italy

Site Status

A.o. Universitaria Pisana; Dipartimento Cardio Toracico

Pisa, Tuscany, Italy

Site Status

Azienda Ospedaliera di Padova

Padua, Veneto, Italy

Site Status

Tosei General Hospital; Respiratory and Allergy Medicine

Aichi, , Japan

Site Status

Ofuji Clinic

Amagasaki-shi, , Japan

Site Status

Kyushu Central Hospital

Fukuoka, , Japan

Site Status

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Oji General Hospital

Hokkaido, , Japan

Site Status

National Hospital Organization Asahikawa Medical Center

Hokkaido, , Japan

Site Status

Yokohama City Minato Red Cross Hospital

Kanagawa, , Japan

Site Status

National Hospital Organization Tokyo National Hospital

Kiyose-shi, , Japan

Site Status

Kochi Medical School Hospital

Kochi, , Japan

Site Status

Oki Clinic

Kodaira-shi, , Japan

Site Status

Takahashi Clinic

Kokubunji-shi, , Japan

Site Status

Dokkyo Medical University Koshigaya Hospital

Koshigaya-shi, , Japan

Site Status

Tono Chuo Clinic

Mizunami-shi, , Japan

Site Status

Nagaoka Red Cross Hospital

Nagaoka-shi, , Japan

Site Status

Niigata City General Hospital

Niigata, , Japan

Site Status

Iwate Medical University Hospital

Numakunai, , Japan

Site Status

Osaka City University Hospital

Osaka, , Japan

Site Status

Touda Clinic

Osaka, , Japan

Site Status

Kinki-Chuo Chest Medical Center

Osaka, , Japan

Site Status

Senzoku Kokyuuki and Allergy Clinic

Ōta-ku, , Japan

Site Status

Japan Community Health Care Organization Hokkaido Hospital

Sapporo, , Japan

Site Status

Fukuwa Clinic

Tokyo, , Japan

Site Status

Tokyo Center Clinic; Internal Medicine

Tokyo, , Japan

Site Status

Sano Toranomon Clinic

Tokyo, , Japan

Site Status

Showa University Hospital

Tokyo, , Japan

Site Status

Teikyo University Hospital

Tokyo, , Japan

Site Status

Sekino Hospital

Toshima City, , Japan

Site Status

University of Fukui Hospital

Yoshida-gun, , Japan

Site Status

Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

Guadalajara, , Mexico

Site Status

Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC

Zapopan, , Mexico

Site Status

NZ Respiratory & Sleep Institute

Auckland, , New Zealand

Site Status

Dunedin Hospital

Dunedin, , New Zealand

Site Status

RMC Medical Research Ltd

Dunedin, , New Zealand

Site Status

P3 Research

Tauranga, , New Zealand

Site Status

Centrum Medycyny Oddechowej Robert M. Mróz

Bialystok, , Poland

Site Status

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, , Poland

Site Status

Specjalistyczne Centrum Medyczne NOWOMED

Krakow, , Poland

Site Status

Grazyna Pulka Specjalistyczny Ośrodek ALL-MED

Krakow, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

Krakow, , Poland

Site Status

Poradnia Pulmonologiczna dla Doroslych

Lódz, , Poland

Site Status

Centrum Alergologii Teresa Hofman

Poznan, , Poland

Site Status

SPZOZ Proszowice

Proszowice, , Poland

Site Status

Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.

Skarżysko-Kamienna, , Poland

Site Status

Medica Pro Familia Sp. z o.o. S.K.A.

Warsaw, , Poland

Site Status

Klinika Chorób Wewnetrznych i Alergologii MSW

Warsaw, , Poland

Site Status

ALL-MED Specjalistyczna Opieka Medyczna

Wroclaw, , Poland

Site Status

Colentina Clinical Hospital

Bucharest, , Romania

Site Status

Prof.Dr.Octavian Fodor Emergency Clinical Hospital

Cluj-Napoca, , Romania

Site Status

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova

Craiova, , Romania

Site Status

Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

Timișoara, , Romania

Site Status

SIH Kemerovo Regional Clinical Hospital

Kemerovo, , Russia

Site Status

Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases

Moscow, , Russia

Site Status

Central Clinical Hospital #1 of RZhD JCS

Moscow, , Russia

Site Status

Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

Novosibirsk, , Russia

Site Status

Ryazan Regional Clinical Hosp

Ryazan, , Russia

Site Status

City Outpatient Dept #94

Saint Petersburg, , Russia

Site Status

St-Petersburg Diagnostic Ctr#1; Pulmonology

Saint Petersburg, , Russia

Site Status

SHI Ctr Occupational Pathology

Saint Petersburg, , Russia

Site Status

St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital

Saint Petersburg, , Russia

Site Status

St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department

Saint Petersburg, , Russia

Site Status

St. George the Martyr City Hospital

Saint Petersburg, , Russia

Site Status

Smolensk State Medical Academy

Smolensk, , Russia

Site Status

Tomsk Regional Clinical Hospital

Tomsk, , Russia

Site Status

Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Clinical Hospital Center Zvezdara

Belgrade, , Serbia

Site Status

Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology

Belgrade, , Serbia

Site Status

Alian s.r.o.

Bardejov, , Slovakia

Site Status

Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.

Bratislava, , Slovakia

Site Status

Plucna ambulancia

Spišská Nová Ves, , Slovakia

Site Status

Melomed Hospital Gatesville

Cape Town, , South Africa

Site Status

Uni of Cape Town Lung Inst.

Cape Town, , South Africa

Site Status

Vawda Z.Fa Practice

Durban, , South Africa

Site Status

Gatesville Medical Centre

Gatesville, , South Africa

Site Status

Deepak Lakha MBCHB Private Practice

Johannesburg, , South Africa

Site Status

Botho ke Bontle Health Services

Pretoria, , South Africa

Site Status

Dr Johannes Breedt; Emmed Research

Pretoria, , South Africa

Site Status

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

St. Paul's Hospital, The Catholic University of Korea, College of Medicine

Seoul, , South Korea

Site Status

Wonju Christian Hospital

Wŏnju, , South Korea

Site Status

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain

Site Status

Hospital de la Santa Creu; i Sant Pau

Barcelona, , Spain

Site Status

Hospital Germans Trias i Pujol

Barcelona, , Spain

Site Status

Hosp Univ Fundacion Alcorcon

Madrid, , Spain

Site Status

Hospital Virgen del Rocio

Seville, , Spain

Site Status

Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status

Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Uludag University; Pulmonology and Allergy Department

Bursa, , Turkey (Türkiye)

Site Status

Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi

Çanakkale, , Turkey (Türkiye)

Site Status

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Site Status

Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

Kirikkale Universitesi Tip Fakultesi Hastanesi

Kırıkkale, , Turkey (Türkiye)

Site Status

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Site Status

Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

Dnipro, , Ukraine

Site Status

Educational Scientific Medical Centre of Donetsk National Medical University;

Donetsk, , Ukraine

Site Status

Regional Phthisiology and Pulmonology Center

Ivano-Frankivsk, , Ukraine

Site Status

City Clinical Hospital #27

Kharkiv, , Ukraine

Site Status

Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy

Kharkiv, , Ukraine

Site Status

Central Outpatient Hospital of Desnyansky District

Kyiv, , Ukraine

Site Status

Yanovskyy Inst of Phth. & Pulm; Clinical-functional

Kyiv, , Ukraine

Site Status

Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

Site Status

Kyiv City Clinical Hospital #8

Kyiv, , Ukraine

Site Status

Danylo Halytskyy National Medical University; Lviv

Lviv, , Ukraine

Site Status

Small Business Private Enterprise Medical Centre Pulse

Vinnytsia, , Ukraine

Site Status

Municipal Institution of Health Care "Yevpatoriya City Hospital №1

Yevpatoria, , Ukraine

Site Status

SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia

Zaporizhzhia, , Ukraine

Site Status

St Peters Hospital

Chertsey, , United Kingdom

Site Status

Castle Hill Hospital; Respiratory Medicine

Cottingham, , United Kingdom

Site Status

Ninewells Hospital; Asthma and Allergy Research Group

Dundee, , United Kingdom

Site Status

St James University Hospital; Respiratory Department

Leeds, , United Kingdom

Site Status

University North Tees

Teesside, , United Kingdom

Site Status

Countries

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

United States Argentina Australia Belgium Canada Chile Colombia Czechia France Germany Hungary Israel Italy Japan Mexico New Zealand Poland Romania Russia Serbia Slovakia South Africa South Korea Spain Turkey (Türkiye) 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.

2013-000175-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GB28688

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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