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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1068 participants
INTERVENTIONAL
2013-07-31
2017-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lebrikizumab (125 mg)
Participants will receive SC injection of lebrikizumab (125 mg) every 4 weeks for 104 weeks.
Lebrikizumab
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.
Lebrikizumab
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.
Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Placebo
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Interventions
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Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Placebo
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Medical Research of Arizona; Allergy, Asthma & Immu
Scottsdale, Arizona, United States
Quality of Life Medical & Research Center
Tucson, Arizona, United States
Kern Allergy Med Clinic, Inc.
Bakersfield, California, United States
Allergy and Asthma Relief Experts
Granada Hills, California, United States
Southern California Institute For Respiratory
Los Angeles, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
Integrated Research Group Inc
Upland, California, United States
Allergy & Asthma Medical Group; Clinical Research Division
Walnut Creek, California, United States
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, United States
Storms Clinical Research; Institute
Colorado Springs, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Colorado Allergy & Asthma Centers, Pc
Denver, Colorado, United States
Western States Clinical Research, Inc
Wheat Ridge, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Allergy Consultants PA
Boca Raton, Florida, United States
Research Institute of South Florida Inc
Miami, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Georgia Pollens
Albany, Georgia, United States
Brookstone Clinical Res Ctr
Columbus, Georgia, United States
Southeast Regional Research Group
Columbus, Georgia, United States
DataQuest Medical Research
Lawrenceville, Georgia, United States
Aeroallergy Research Labs
Savannah, Georgia, United States
Atlanta Allergy & Asthma Clini
Woodstock, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Asthma & Allergy of Idaho
Twin Falls, Idaho, United States
The Allergy and Asthma Center
Fort Wayne, Indiana, United States
Cotton O'Neil Clinic; Stormont-Vail Hlth Care
Topeka, Kansas, United States
Dr. Paul Shapero
Bangor, Maine, United States
Asthma, Allergy & Sinus Center
Baltimore, Maryland, United States
Chesapeake Clinical Research
Baltimore, Maryland, United States
Howard County Center for Lung and Sleep, LLC
Columbia, Maryland, United States
Infinity Medical Research Inc
North Dartmouth, Massachusetts, United States
Clinical Research Inst
Minneapolis, Minnesota, United States
Asthma and Allergy Physicians LLC
Brockton, Mississippi, United States
Allergy Associates, Inc.
Chesterfield, Missouri, United States
Center For Pharmaceutical Research
Kansas City, Missouri, United States
Clinical Research Center, L.L.C.
St Louis, Missouri, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Adult Pediatric Allergy Central Jersey
Edison, New Jersey, United States
Patrick V. Perin, MD
Teaneck, New Jersey, United States
University of New Mexico; School of Med
Albuquerque, New Mexico, United States
Winthrop Univ Hospital
Mineola, New York, United States
Allergy Partners of Western NC
Asheville, North Carolina, United States
Allergy & Asthma Centre of Dayton
Centerville, Ohio, United States
Integrity People Services Research Company
Oklahoma City, Oklahoma, United States
Oklahoma Institute of Allergy and Asthma Clinical Research LLC
Oklahoma City, Oklahoma, United States
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Asthma and Allergy Research Associates
Upland, Pennsylvania, United States
Neem Research Group, Inc.
Columbia, South Carolina, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, United States
Upstate Pharmaceutical Research; Greenville
Greenville, South Carolina, United States
Future Search Clinical Trials L.P.
Austin, Texas, United States
Elliot J. Ginchansky, MD, PA
Dallas, Texas, United States
EPIMRD, Inc. DBA Western Sky Medical Research
El Paso, Texas, United States
Baylor College of Medicine; Dept of Medicine
Houston, Texas, United States
Allergy & Asthma Clin Cen TX
Round Rock, Texas, United States
Quality Assurance Research Ctr
San Antonio, Texas, United States
Discovery Clinical Trials
San Antonio, Texas, United States
Allergy & Asthma Research Center
San Antonio, Texas, United States
Live Oak Allergy & Asthma Clinic
San Antonio, Texas, United States
Allergy Associates of Utah
Murray, Utah, United States
Pulmonary Research of Albingdon
Abingdon, Virginia, United States
University of Wisconsin;Allergy & Asthma Clinical Research
Madison, Wisconsin, United States
Instituto de Investigaciones Clinicas-Mar del Plata
Buenos Aires, , Argentina
Fundacion Cidea
Buenos Aires, , Argentina
Centro Respiratorio Infantil
Rosario, , Argentina
Centro Modelo de Cardiologia
San Miguel de Tucumán, , Argentina
CEMER Centro Médico de Enfermedades Respiratorias
Vicente López, , Argentina
Concord Repatriation General Hospital; Department Thoracic Medicine
Sydney, New South Wales, Australia
AusTrials
Brisbane, Queensland, Australia
Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
Brisbane, Queensland, Australia
Respiratory Clinical Trials Pty Ltd
Toorak Gardens, South Australia, Australia
The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Private Practice
Jambes, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
Rousse, , Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, , Bulgaria
5TH MHAT; Pulmonology
Sofia, , Bulgaria
National Multiprofile Hospital Tsar Boris III
Sofia, , Bulgaria
Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases
Sofia, , Bulgaria
SHATPD Sveta Sofia; Clin Pulmonary Diseases
Sofia, , Bulgaria
Alitera - Med - Medical Center EOOD
Sofia, , Bulgaria
Multiprofile Hospital For Active Treatment prof Kirkovich
Stara Zagora, , Bulgaria
Diagnostic and Consulting Centre Mladost - M OOD
Varna, , Bulgaria
Medical Center Tara OOD
Veliko Tarnovo, , Bulgaria
Cheema Research, Inc
Mississauga, Ontario, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, Canada
Del Carpio Jaime Dr - Allergiste & Immunologue
Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Ordinace pro tuberkulozu a respiracni nemoci
Strakonice, , Czechia
KASMED, s.r.o.; Alergologie a klinicka imunologie
Tábor, , Czechia
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital de La Croix Rousse
Lyon, , France
Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
Paris, , France
Hopital Bichat Claude Bernard ; Service de Pneumologie
Paris, , France
Medaimun GmbH
Frankfurt am Main, , Germany
Pneumologisches Forschungsinstitut
Großhansdorf, , Germany
Praxis Dr. med. Hermann A. Trauth
Marburg, , Germany
Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
Debrecen, , Hungary
Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés
Komárom, , Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , Hungary
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center; Pulmonary Institute
Jerusalem, , Israel
Nazareth EMMS Hospital
Nazareth, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, , Israel
Azienda Ospedaliera Monaldi
Napoli, Campania, Italy
Azienda Ospedaliera Universitaria di Modena
Modena, Emilia-Romagna, Italy
Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli
Rome, Lazio, Italy
Asst Santi Paolo E Carlo
Milan, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria
Pavia, Lombardy, Italy
P.O. Citta' Di Sesto S. Giovanni
Sesto San Giovanni, Lombardy, Italy
Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
Catania, Sicily, Italy
Banbuntane Hotokukai Hospital
Aichi, , Japan
Fukuoka National Hospital
Fukuoka, , Japan
Hiroshima Allegy & Respiratory Clinic
Hiroshima, , Japan
Ibarakihigashi National Hospital
Ibaraki, , Japan
Uno Naikakokyukika Clinic
Isesaki-shi, , Japan
Yokohama City University Medical Center; Neurology
Kanagawa, , Japan
Sagamihara National Hospital
Kanagawa, , Japan
Kumamoto Saishunso National Hospital
Koshi-shi, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kyoto University Hospital, Respiratory Medicine
Kyoto, , Japan
Machida Municipal Hospital
Machida-shi, , Japan
Hikarigaoka Spellman Hospital; Rheumatology
Miyagi, , Japan
Nagoya Ekisaikai Hospital
Nagoya, , Japan
Okayama University Hospital
Okayama, , Japan
Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease
Osaka, , Japan
Kinki University Hospital
Osaka, , Japan
Kishiwada City Hospital
Osaka, , Japan
Tohoku Medical and Pharmaceutical University Wakabayashi Hospital
Sendai, , Japan
Iwata City Hospital
Shizuoka, , Japan
Takamatsu Municipal Hospital
Takamatsu, , Japan
Hanzomon Hospital
Tokyo, , Japan
Tokyo-Eki Center-building Clinic
Tokyo, , Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
Toyama City Hospital
Toyama, , Japan
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, , Mexico
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, , Mexico
Consultorio Especialidad Alergologia Pediatrica
Villahermosa, , Mexico
Greenlane Clinical Centre
Auckland, , New Zealand
Canterbury Respiratory Research Group; Respiratory
Christchurch, , New Zealand
P3 Research
Tauranga, , New Zealand
Medical Research Inst. of New Zealand; Respiratory
Wellington, , New Zealand
Hospital Nacional Adolfo; Guevara Velasco Essalud
Cusco, , Peru
Hospital Nacional Luis N Saenz PNP
Lima, , Peru
Clinica Internacional
Lima, , Peru
ABK Reuma SRL- Medicentro BioCiencias
Lima, , Peru
Centro de Investigación Ricardo Palma
Lima, , Peru
Instituto Peruano de Investigacion en Ciencias Medicas
Lima, , Peru
Clinica San Pablo
Lima, , Peru
Clinica San Borja
Lima, , Peru
Clinica los Andes
Miraflores, , Peru
SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce
Bieńnkówka, , Poland
GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
Krakow, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Specjalistyczna Poradnia Pulmonologiczna
Ostrów Wielkopolski, , Poland
Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic
Piła, , Poland
ABC-PULMO Poradnia Chorob Pluc
Radom, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
Ruda Śląska, , Poland
Centrum Medyczne Ogrodowa
Skierniewice, , Poland
Alergo Medical Specjalistyczna Przychodnia Lekarska
Tarnów, , Poland
Lexmedica
Wroclaw, , Poland
Dobrostan Gabinety Lekarskie
Wroclaw, , Poland
NZOZ Lekarze Specjalisci
Wroclaw, , Poland
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
Cluj-Napoca, , Romania
Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta
Palazu Mare, , Romania
Targu Mures Clinical Emergency County Hospital
Târgu Mureş, , Romania
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
Timișoara, , Romania
City Clinical Hospital #13
Moscow, , Russia
I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
Moscow, , Russia
City Clinical Hospital #2
Novosibirsk, , Russia
Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department
Penza, , Russia
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, , Russia
Municipal Polyclinic #25
Saint Petersburg, , Russia
St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth
Saint Petersburg, , Russia
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, , Russia
City Hospital #40 of Resort Administrative District
Saint Petersburg, , Russia
Saratov State Medical Univ; Clinical Immun & Allerg
Saratov, , Russia
Siberian State Medical University
Tomsk, , Russia
Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital
Yaroslavl, , Russia
Yaroslavl State Medical Academy - Clinical Hospital #2
Yaroslavl, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Institute of Lung Diseases Vojvodina
Kamenitz, , Serbia
Clinical Hospital Centre Zemun
Zemun, , Serbia
Pneumo-Alergo Centrum s.r.o.
Bratislava, , Slovakia
ZAPA JJ Sro
Levice, , Slovakia
Imunoalergologia Dzurilla s.r.o.
Nitra, , Slovakia
Respiratory Research Unit
Cape Town, , South Africa
Tiervalei Trial Centre
Cape Town, , South Africa
St Augustines Hospital; Infectoilogy
Durban, , South Africa
Dr PJ Sebastian
Durban, , South Africa
Aliwal Shoal Medical Center
eMkhomazi, , South Africa
Limpopo Clinical Research Initiative; Tamboti Medical Centre
Tabazimbi, , South Africa
Clinical Projects Research
Worcester, , South Africa
Chonnam National University Hospital
Gwangju, , South Korea
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Seoul National University Hospital; Division of Allergy and Clinical Immunology
Seoul, , South Korea
Ewha Womans University Medical Center
Seoul, , South Korea
Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
Majadahonda, Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Instituto de Ciencias Medicas
Alicante, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institut Catala de Serveis Medics
Girona, , Spain
Hospital Universitario la Paz; Servicio de Alergologia
Madrid, , Spain
Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
Kyiv, Kiev Governorate, Ukraine
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, , Ukraine
MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council
Dnipropetrovsk, , Ukraine
Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1
Donetsk, , Ukraine
Municipal Institution of Health Care City Clinical Hospital #13
Kharkiv, , Ukraine
SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
Kharkiv, , Ukraine
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
Kyiv, , Ukraine
City Hospital #1
Mykolaiv, , Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, , Ukraine
City Clinical Hospital No.1; Therap Ukr Med Stom Acad
Poltava, , Ukraine
Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine
Vinnytsia, , Ukraine
LLC Diaservis
Zaporizhzhia, , Ukraine
Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9
Zaporizhzhye, , Ukraine
Raigmore Hospital
Inverness, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Royal Hallamshire Hospital; Department of Oncology
Sheffield, , United Kingdom
Southmead Hospital
Westbury-on-Trym, Bristol, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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2013-000176-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB28689
Identifier Type: -
Identifier Source: org_study_id
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