Clinical trial NCT01867125: A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are 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: 2013-06-03
Enrollment: 1081
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
timeFrame: Baseline up to 52 weeks
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 52 weeks
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 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: Percentage of Participants With Adverse Events
timeFrame: Baseline, Week 124
measure: Minimum Serum Concentration (Cmin) of Lebrikizumab
timeFrame: Predose (0 hour) on Weeks 4, 12, 24, 36, and 52
Other outcomes:
Locations:
city: Pell City
country: United States
facility: Alabama Clinical Research Associates
state: Alabama
city: Flagstaff
country: United States
facility: Clinical Trial Connection
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Clinical Research LLC
state: Arizona
city: Fountain Valley
country: United States
facility: Allianz Medical and Research Center
state: California
city: Long Beach
country: United States
facility: Allergy & Asthma Medical Group & Research Center, Pc
state: California
city: Long Beach
country: United States
facility: Alliance Research LLC
state: California
city: Los Angeles
country: United States
facility: Allergy Medical Clinic
state: California
city: Los Angeles
country: United States
facility: CA Allergy & Asthma Med Grp
state: California
city: Napa
country: United States
facility: North Bay Clinical Trials
state: California
city: Orange
country: United States
facility: Choc Psf, Amc
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: San Diego
country: United States
facility: Allergy Assoc Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF School of Medicine
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Waterbury
country: United States
facility: Waterbury Pulmonary Associates
state: Connecticut
city: Clearwater
country: United States
facility: St. Francis Sleep; Allergy & Lung Institute
state: Florida
city: DeLand
country: United States
facility: Creekside Medical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group LLC
state: Florida
city: Miami
country: United States
facility: South Florida Research Phase I-IV, Inc
state: Florida
city: Ocala
country: United States
facility: Allergy & Asthma Care of FL; Clinical Research
state: Florida
city: Panama City
country: United States
facility: Emerald Coast Research Associates
state: Florida
city: Tallahassee
country: United States
facility: Allergy & Asthma Diagnostic; Treatment Center
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Decatur
country: United States
facility: Southeastern Lung Care
state: Georgia
city: Woodstock
country: United States
facility: Atlanta Allergy & Asthma Clini
state: Georgia
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research
state: Indiana
city: Iowa City
country: United States
facility: Iowa Clinical Research Corporation
state: Iowa
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc
state: Massachusetts
city: Grand Rapids
country: United States
facility: Infusion Associates
state: Michigan
city: Saint Louis
country: United States
facility: Midwest Clinical Research LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington Univ. School of Med
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research LLC
state: Montana
city: Omaha
country: United States
facility: Heartland Clinical Research Inc.
state: Nebraska
city: Papillion
country: United States
facility: Asthma & Allergy Center, P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Allergy & Asthma Associates
state: Nevada
city: Mount Laurel
country: United States
facility: Allergy & Asthma Research of Nj, Inc
state: New Jersey
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center For Clinical Research
state: New Jersey
city: New Hyde Park
country: United States
facility: North Shore University Hosp
state: New York
city: The Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: High Point
country: United States
facility: Allergy & Asthma Center of NC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Toledo
country: United States
facility: Asthma & Allergy Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cor Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Eugene
country: United States
facility: Allergy & Asthma Research Grp
state: Oregon
city: Medford
country: United States
facility: Clinical Research Inst. of Southern Oregon, Pc
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Altoona
country: United States
facility: Central PA Asth & Allergy Care; Research Division
state: Pennsylvania
city: Philadelphia
country: United States
facility: Asthma Allergy Pulm Associates
state: Pennsylvania
city: Sellersville
country: United States
facility: Grand View Hospital; Clinical Research Department
state: Pennsylvania
city: Lincoln
country: United States
facility: Asthma Allergy Phys of RI
state: Rhode Island
city: Greenville
country: United States
facility: ADAC Research PA
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Austin
country: United States
facility: Tekton Research Inc
state: Texas
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting, Inc.
state: Texas
city: El Paso
country: United States
facility: Allergy & Asthma Research Center of El Paso
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonology & Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Ctr
state: Texas
city: Fairfax
country: United States
facility: O & O Alpan, LLC
state: Virginia
city: Henrico
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy & Immunology
state: Washington
city: Seattle
country: United States
facility: ASTHMA, Inc
state: Washington
city: Spokane
country: United States
facility: Marycliff Allergy Specialists
state: Washington
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Fundación Faicep
city: Buenos Aires
country: Argentina
facility: Centro Médico Dra de Salvo
city: Mar Del Plata
country: Argentina
facility: Instituto Ave Pulmo
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones en Patologias Respiratorias
city: Liverpool BC
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital; Eastern Clinical Research Unit
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Nedlands
country: Australia
facility: The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
state: Western Australia
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
city: Mississauga
country: Canada
facility: Dr. E. Amer
state: Ontario
city: Toronto
country: Canada
facility: Inspiration Research Limited
state: Ontario
city: Toronto
country: Canada
facility: Albion Finch Medical Centre
state: Ontario
city: Trois-Rivières
country: Canada
facility: Centre d'investigation Clinique Mauricie
state: Quebec
city: Santiago
country: Chile
facility: Centro de Investigaciones Medicas Respiratorias
city: Santiago
country: Chile
facility: Schonffeldt y Guerrero Limitada
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
city: Bogota DC
country: Colombia
facility: Fundacion Neumologica Colombiana
city: Jablonec Nad Nisou
country: Czechia
facility: Alergopraktik s.r.o.
city: Jindrichuv Hradec
country: Czechia
facility: Interni A Pneumologicka Ambulance
city: Ostrava - Poruba
country: Czechia
facility: MephaCentrum, a.s.
city: Teplice
country: Czechia
facility: Alergologie Teplice, s.r.o.
city: Lille
country: France
facility: Hopital Calmette; Pneumologie
city: Marseille
country: France
facility: Hopital Nord; CIC
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: CHU Nantes - Hôpital Laennec; Service de Pneumologie
city: Strabourg
country: France
facility: Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
city: Berlin
country: Germany
facility: Lungenarztpraxis Tegel
city: Wiesloch
country: Germany
facility: Pneumologisches Zentrum Wiesloch
city: Debrecen
country: Hungary
facility: Kenezy Korhaz Rendelointezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Szeged
country: Hungary
facility: C.C.C. Hospital Chest Diseases
city: Ashkelon
country: Israel
facility: Barzilai Medical Center; Pulmonary Inst.
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center; Cardiovascular Medicine
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Pulmonary Dept
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Catanzaro
country: Italy
facility: University of Catanzaro
state: Calabria
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
state: Emilia-Romagna
city: Torrette - Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
state: Marche
city: Cassano Murge (BA)
country: Italy
facility: Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia
state: Puglia
city: Pisa
country: Italy
facility: A.o. Universitaria Pisana; Dipartimento Cardio Toracico
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Veneto
city: Aichi
country: Japan
facility: Tosei General Hospital; Respiratory and Allergy Medicine
city: Amagasaki-shi
country: Japan
facility: Ofuji Clinic
city: Fukuoka-shi
country: Japan
facility: Kyushu Central Hospital
city: Higashiibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: Oji General Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
city: Kanagawa
country: Japan
facility: Yokohama City Minato Red Cross Hospital
city: Kiyose-shi
country: Japan
facility: National Hospital Organization Tokyo National Hospital
city: Kochi
country: Japan
facility: Kochi Medical School Hospital
city: Kodaira-shi
country: Japan
facility: Oki Clinic
city: Kokubunji-shi
country: Japan
facility: Takahashi Clinic
city: Koshigaya-shi
country: Japan
facility: Dokkyo Medical University Koshigaya Hospital
city: Mizunami-shi
country: Japan
facility: Tono Chuo Clinic
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital
city: Niigata-shi
country: Japan
facility: Niigata City General Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Touda Clinic
city: Osaka
country: Japan
facility: Kinki-Chuo Chest Medical Center
city: Ota-ku
country: Japan
facility: Senzoku Kokyuuki and Allergy Clinic
city: Sapporo-shi
country: Japan
facility: Japan Community Health Care Organization Hokkaido Hospital
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: Tokyo Center Clinic; Internal Medicine
city: Tokyo
country: Japan
facility: Sano Toranomon Clinic
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Tokyo
country: Japan
facility: Teikyo University Hospital
city: Toshima
country: Japan
facility: Sekino Hospital
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital, The Catholic University of Korea, College of Medicine
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
city: Zapopan
country: Mexico
facility: Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC
city: Auckland
country: New Zealand
facility: NZ Respiratory & Sleep Institute
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Dunedin
country: New Zealand
facility: RMC Medical Research Ltd
city: Tauranga
country: New Zealand
facility: P3 Research
city: Bialystok
country: Poland
facility: Centrum Medycyny Oddechowej Robert M. Mróz
city: Bialystok
country: Poland
facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
city: Krakow
country: Poland
facility: Grazyna Pulka Specjalistyczny Ośrodek ALL-MED
city: Kraków
country: Poland
facility: Specjalistyczne Centrum Medyczne NOWOMED
city: Kraków
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
city: Lódz
country: Poland
facility: Poradnia Pulmonologiczna dla Doroslych
city: Poznan
country: Poland
facility: Centrum Alergologii Teresa Hofman
city: Proszowice
country: Poland
facility: SPZOZ Proszowice
city: Skarżysko-Kamienna
country: Poland
facility: Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.
city: Warszawa
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A.
city: Warszawa
country: Poland
facility: Klinika Chorób Wewnetrznych i Alergologii MSW
city: Wroclaw
country: Poland
facility: ALL-MED Specjalistyczna Opieka Medyczna
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Cluj-Napoca
country: Romania
facility: Prof.Dr.Octavian Fodor Emergency Clinical Hospital
city: Craiova
country: Romania
facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
city: Timisoara
country: Romania
facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
city: Kemerovo
country: Russian Federation
facility: SIH Kemerovo Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital #1 of RZhD JCS
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hosp
city: Saint Petersburg
country: Russian Federation
facility: St. George the Martyr City Hospital
city: Saint-Petersburg
country: Russian Federation
facility: St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: St Petersburg
country: Russian Federation
facility: City Outpatient Dept #94
city: St. Petersburg
country: Russian Federation
facility: St-Petersburg Diagnostic Ctr#1; Pulmonology
city: St. Petersburg
country: Russian Federation
facility: SHI Ctr Occupational Pathology
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Belgrade
country: Serbia
facility: Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
city: Bardejov
country: Slovakia
facility: Alian s.r.o.
city: Bratislava
country: Slovakia
facility: Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.
city: Spisska Nova Ves
country: Slovakia
facility: Plucna ambulancia
city: Cape Town
country: South Africa
facility: Melomed Hospital Gatesville
city: Cape Town
country: South Africa
facility: Uni of Cape Town Lung Inst.
city: Durban
country: South Africa
facility: Vawda Z.Fa Practice
city: Gatesville
country: South Africa
facility: Gatesville Medical Centre
city: Johannesburg
country: South Africa
facility: Deepak Lakha MBCHB Private Practice
city: Pretoria
country: South Africa
facility: Botho ke Bontle Health Services
city: Pretoria
country: South Africa
facility: Dr Johannes Breedt; Emmed Research
city: Vitoria
country: Spain
facility: Hospital Universitario Araba
state: Alava
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu; i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hosp Univ Fundacion Alcorcon
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Ankara
country: Turkey
facility: Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
city: Ankara
country: Turkey
facility: Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi
city: Bursa
country: Turkey
facility: Uludag University; Pulmonology and Allergy Department
city: Canakkale
country: Turkey
facility: Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
city: Kirikkale
country: Turkey
facility: Kirikkale Universitesi Tip Fakultesi Hastanesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Dnepropetrovsk
country: Ukraine
facility: Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
city: Donetsk
country: Ukraine
facility: Educational Scientific Medical Centre of Donetsk National Medical University;
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Phthisiology and Pulmonology Center
city: Kharkiv
country: Ukraine
facility: City Clinical Hospital #27
city: Kharkiv
country: Ukraine
facility: Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy
city: Kyiv
country: Ukraine
facility: Central Outpatient Hospital of Desnyansky District
city: Kyiv
country: Ukraine
facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional
city: Kyiv
country: Ukraine
facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #8
city: Lviv
country: Ukraine
facility: Danylo Halytskyy National Medical University; Lviv
city: Vinnytsya
country: Ukraine
facility: Small Business Private Enterprise Medical Centre Pulse
city: Yevpatoriya
country: Ukraine
facility: Municipal Institution of Health Care "Yevpatoriya City Hospital №1
city: Zaporizhzhia
country: Ukraine
facility: SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia
city: Chertsey
country: United Kingdom
facility: St Peters Hospital
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital; Respiratory Medicine
city: Dundee
country: United Kingdom
facility: Ninewells Hospital; Asthma and Allergy Research Group
city: Leeds
country: United Kingdom
facility: St James University Hospital; Respiratory Department
city: Teesside
country: United Kingdom
facility: University North Tees
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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