Clinical trial NCT01868061: A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 1068
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Week 52
measure: Time to First Asthma Exacerbation
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score
timeFrame: Baseline, Week 52
measure: Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)
timeFrame: Baseline, Week 52
measure: Rate of Urgent Asthma-Related Urgent Health Care Utilization
timeFrame: Baseline up to Week 52
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to Week 124
measure: Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab
timeFrame: Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)
measure: Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
timeFrame: Baseline, Week 52
measure: Minimum Serum Concentration (Cmin) of Lebrikizumab
timeFrame: Predose (0 hour) on Weeks 4, 12, 24, 36, and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona; Allergy, Asthma & Immu
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center
state: Arizona
city: Bakersfield
country: United States
facility: Kern Allergy Med Clinic, Inc.
state: California
city: Granada Hills
country: United States
facility: Allergy and Asthma Relief Experts
state: California
city: Los Angeles
country: United States
facility: Southern California Institute For Respiratory
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Upland
country: United States
facility: Integrated Research Group Inc
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group; Clinical Research Division
state: California
city: Colorado Springs
country: United States
facility: Asthma & Allergy; Associates, P.C.
state: Colorado
city: Colorado Springs
country: United States
facility: Storms Clinical Research; Institute
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy & Asthma Centers, Pc
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research, Inc
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Boca Raton
country: United States
facility: Allergy Consultants PA
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida Inc
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Albany
country: United States
facility: Georgia Pollens
state: Georgia
city: Columbus
country: United States
facility: Brookstone Clinical Res Ctr
state: Georgia
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Lawrenceville
country: United States
facility: DataQuest Medical Research
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Labs
state: Georgia
city: Woodstock
country: United States
facility: Atlanta Allergy & Asthma Clini
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Twin Falls
country: United States
facility: Asthma & Allergy of Idaho
state: Idaho
city: Fort Wayne
country: United States
facility: The Allergy and Asthma Center
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Clinic; Stormont-Vail Hlth Care
state: Kansas
city: Bangor
country: United States
facility: Dr. Paul Shapero
state: Maine
city: Baltimore
country: United States
facility: Asthma, Allergy & Sinus Center
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Howard County Center for Lung and Sleep, LLC
state: Maryland
city: North Dartmouth
country: United States
facility: Infinity Medical Research Inc
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Inst
state: Minnesota
city: Brockton
country: United States
facility: Asthma and Allergy Physicians LLC
state: Mississippi
city: Chesterfield
country: United States
facility: Allergy Associates, Inc.
state: Missouri
city: Kansas City
country: United States
facility: Center For Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Center, L.L.C.
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Edison
country: United States
facility: Adult Pediatric Allergy Central Jersey
state: New Jersey
city: Teaneck
country: United States
facility: Patrick V. Perin, MD
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico; School of Med
state: New Mexico
city: Mineola
country: United States
facility: Winthrop Univ Hospital
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western NC
state: North Carolina
city: Centerville
country: United States
facility: Allergy & Asthma Centre of Dayton
state: Ohio
city: Oklahoma City
country: United States
facility: Integrity People Services Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma Clinical Research LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clin Res Pc
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Upland
country: United States
facility: Asthma and Allergy Research Associates
state: Pennsylvania
city: Columbia
country: United States
facility: Neem Research Group, Inc.
state: South Carolina
city: Greenville
country: United States
facility: Greenville Pharmaceutical Research
state: South Carolina
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research; Greenville
state: South Carolina
city: Austin
country: United States
facility: Future Search Clinical Trials L.P.
state: Texas
city: Dallas
country: United States
facility: Elliot J. Ginchansky, MD, PA
state: Texas
city: El Paso
country: United States
facility: EPIMRD, Inc. DBA Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine; Dept of Medicine
state: Texas
city: Round Rock
country: United States
facility: Allergy & Asthma Clin Cen TX
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Ctr
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Allergy & Asthma Research Center
state: Texas
city: San Antonio
country: United States
facility: Live Oak Allergy & Asthma Clinic
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: Abingdon
country: United States
facility: Pulmonary Research of Albingdon
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin;Allergy & Asthma Clinical Research
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas-Mar del Plata
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
city: Rosario
country: Argentina
facility: Centro Respiratorio Infantil
city: San Miguel de Tucuman
country: Argentina
facility: Centro Modelo de Cardiologia
city: Vicente López
country: Argentina
facility: CEMER Centro Médico de Enfermedades Respiratorias
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital; Department Thoracic Medicine
state: New South Wales
city: Brisbane
country: Australia
facility: AusTrials
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
state: Queensland
city: Toorak Gardens
country: Australia
facility: Respiratory Clinical Trials Pty Ltd
state: South Australia
city: Nedlands
country: Australia
facility: The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
state: Western Australia
city: Jambes
country: Belgium
facility: Private Practice
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
city: Smolyan
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
city: Sofia
country: Bulgaria
facility: 5TH MHAT; Pulmonology
city: Sofia
country: Bulgaria
facility: National Multiprofile Hospital Tsar Boris III
city: Sofia
country: Bulgaria
facility: Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases
city: Sofia
country: Bulgaria
facility: SHATPD Sveta Sofia; Clin Pulmonary Diseases
city: Sofia
country: Bulgaria
facility: Alitera - Med - Medical Center EOOD
city: Stara Zagora
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment prof Kirkovich
city: Varna
country: Bulgaria
facility: Diagnostic and Consulting Centre Mladost - M OOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Tara OOD
city: Mississauga
country: Canada
facility: Cheema Research, Inc
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Windsor
country: Canada
facility: Dr Anil Dhar Professional Medicine Corporation
state: Ontario
city: Montreal
country: Canada
facility: Del Carpio Jaime Dr - Allergiste & Immunologue
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Strakonice
country: Czechia
facility: Ordinace pro tuberkulozu a respiracni nemoci
city: Tabor
country: Czechia
facility: KASMED, s.r.o.; Alergologie a klinicka imunologie
city: Le Kremlin-bicêtre
country: France
facility: Centre Hospitalier Universitaire de Bicêtre
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Paris
country: France
facility: Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
city: Paris
country: France
facility: Hopital Bichat Claude Bernard ; Service de Pneumologie
city: Frankfurt am Main
country: Germany
facility: Medaimun GmbH
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut
city: Marburg
country: Germany
facility: Praxis Dr. med. Hermann A. Trauth
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center; Pulmonary Institute
city: Nazareth
country: Israel
facility: Nazareth EMMS Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
state: Campania
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria di Modena
state: Emilia-Romagna
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli
state: Lazio
city: Milano
country: Italy
facility: Asst Santi Paolo E Carlo
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria
state: Lombardia
city: Sesto San Giovanni
country: Italy
facility: P.O. Citta' Di Sesto S. Giovanni
state: Lombardia
city: Catania
country: Italy
facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
state: Sicilia
city: Aichi
country: Japan
facility: Banbuntane Hotokukai Hospital
city: Fukuoka
country: Japan
facility: Fukuoka National Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Allegy & Respiratory Clinic
city: Ibaraki
country: Japan
facility: Ibarakihigashi National Hospital
city: Isesaki-shi
country: Japan
facility: Uno Naikakokyukika Clinic
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center; Neurology
city: Kanagawa
country: Japan
facility: Sagamihara National Hospital
city: Koshi-shi
country: Japan
facility: Kumamoto Saishunso National Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital, Respiratory Medicine
city: Machida-shi
country: Japan
facility: Machida Municipal Hospital
city: Miyagi
country: Japan
facility: Hikarigaoka Spellman Hospital; Rheumatology
city: Nagoya-shi
country: Japan
facility: Nagoya Ekisaikai Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease
city: Osaka
country: Japan
facility: Kinki University Hospital
city: Osaka
country: Japan
facility: Kishiwada City Hospital
city: Sendai-shi
country: Japan
facility: Tohoku Medical and Pharmaceutical University Wakabayashi Hospital
city: Shizuoka
country: Japan
facility: Iwata City Hospital
city: Takamatsu-shi
country: Japan
facility: Takamatsu Municipal Hospital
city: Tokyo
country: Japan
facility: Hanzomon Hospital
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Toyama
country: Japan
facility: Toyama City Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital; Division of Allergy and Clinical Immunology
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
city: Villahermosa
country: Mexico
facility: Consultorio Especialidad Alergologia Pediatrica
city: Auckland
country: New Zealand
facility: Greenlane Clinical Centre
city: Christchurch
country: New Zealand
facility: Canterbury Respiratory Research Group; Respiratory
city: Tauranga
country: New Zealand
facility: P3 Research
city: Wellington
country: New Zealand
facility: Medical Research Inst. of New Zealand; Respiratory
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo; Guevara Velasco Essalud
city: Lima
country: Peru
facility: Hospital Nacional Luis N Saenz PNP
city: Lima
country: Peru
facility: Clinica Internacional
city: Lima
country: Peru
facility: ABK Reuma SRL- Medicentro BioCiencias
city: Lima
country: Peru
facility: Centro de Investigación Ricardo Palma
city: Lima
country: Peru
facility: Instituto Peruano de Investigacion en Ciencias Medicas
city: Lima
country: Peru
facility: Clinica San Pablo
city: Lima
country: Peru
facility: Clinica San Borja
city: Miraflores
country: Peru
facility: Clinica los Andes
city: Bieńnkówka
country: Poland
facility: SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce
city: Krakow
country: Poland
facility: GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Ostrow Wielkopolski
country: Poland
facility: Specjalistyczna Poradnia Pulmonologiczna
city: Pila
country: Poland
facility: Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic
city: Radom
country: Poland
facility: ABC-PULMO Poradnia Chorob Pluc
city: Ruda Śląska
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
city: Skierniewice
country: Poland
facility: Centrum Medyczne Ogrodowa
city: Tarnow
country: Poland
facility: Alergo Medical Specjalistyczna Przychodnia Lekarska
city: Wroclaw
country: Poland
facility: Lexmedica
city: Wroclaw
country: Poland
facility: Dobrostan Gabinety Lekarskie
city: Wroclaw
country: Poland
facility: NZOZ Lekarze Specjalisci
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
city: Palazu Mare
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta
city: Targu Mures
country: Romania
facility: Targu Mures Clinical Emergency County Hospital
city: Timisoara
country: Romania
facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #13
city: Moscow
country: Russian Federation
facility: I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #2
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinincal Cardiology Dispensary
city: Saratov
country: Russian Federation
facility: Saratov State Medical Univ; Clinical Immun & Allerg
city: St Petersburg
country: Russian Federation
facility: Municipal Polyclinic #25
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University n.a. I.P. Pavlov
city: St. Petersburg
country: Russian Federation
facility: City Hospital #40 of Resort Administrative District
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Yaroslavl
country: Russian Federation
facility: Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical Academy - Clinical Hospital #2
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Sremska Kamenica
country: Serbia
facility: Institute of Lung Diseases Vojvodina
city: Zemun
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Bratislava
country: Slovakia
facility: Pneumo-Alergo Centrum s.r.o.
city: Levice
country: Slovakia
facility: ZAPA JJ Sro
city: Nitra
country: Slovakia
facility: Imunoalergologia Dzurilla s.r.o.
city: Cape Town
country: South Africa
facility: Respiratory Research Unit
city: Cape Town
country: South Africa
facility: Tiervalei Trial Centre
city: Durban
country: South Africa
facility: St Augustines Hospital; Infectoilogy
city: Durban
country: South Africa
facility: Dr PJ Sebastian
city: Tabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre
city: Umkomaas
country: South Africa
facility: Aliwal Shoal Medical Center
city: Worcester
country: South Africa
facility: Clinical Projects Research
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo
state: La Coruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
state: Madrid
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Sevilla
city: Alicante
country: Spain
facility: Instituto de Ciencias Medicas
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Girona
country: Spain
facility: Institut Catala de Serveis Medics
city: Madrid
country: Spain
facility: Hospital Universitario la Paz; Servicio de Alergologia
city: Kyiv
country: Ukraine
facility: Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
state: Kiev Governorate
city: Cherkasy
country: Ukraine
facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
city: Dnipropetrovsk
country: Ukraine
facility: MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council
city: Donetsk
country: Ukraine
facility: Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Health Care City Clinical Hospital #13
city: Kharkiv
country: Ukraine
facility: SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
city: Kyiv
country: Ukraine
facility: SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
city: Mykolaiv
country: Ukraine
facility: City Hospital #1
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital
city: Poltava
country: Ukraine
facility: City Clinical Hospital No.1; Therap Ukr Med Stom Acad
city: Vinnytsya
country: Ukraine
facility: Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine
city: Zaporizhzhia
country: Ukraine
facility: LLC Diaservis
city: Zaporizhzhye
country: Ukraine
facility: Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital; Department of Oncology
city: Westbury-on-Trym, Bristol
country: United Kingdom
facility: Southmead Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.