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
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
1081 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 milligrams \[mg\]) 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
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.
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 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
* 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
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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Alabama Clinical Research Associates
Pell City, Alabama, United States
Clinical Trial Connection
Flagstaff, Arizona, United States
Desert Sun Clinical Research LLC
Tucson, Arizona, United States
Allianz Medical and Research Center
Fountain Valley, California, United States
Allergy & Asthma Medical Group & Research Center, Pc
Long Beach, California, United States
Alliance Research LLC
Long Beach, California, United States
Allergy Medical Clinic
Los Angeles, California, United States
CA Allergy & Asthma Med Grp
Los Angeles, California, United States
North Bay Clinical Trials
Napa, California, United States
Choc Psf, Amc
Orange, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Allergy Assoc Medical Group
San Diego, California, United States
UCSF School of Medicine
San Francisco, California, United States
Bensch Research Associates
Stockton, California, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
Waterbury Pulmonary Associates
Waterbury, Connecticut, United States
St. Francis Sleep; Allergy & Lung Institute
Clearwater, Florida, United States
Creekside Medical Research
DeLand, Florida, United States
Suncoast Research Group LLC
Miami, Florida, United States
South Florida Research Phase I-IV, Inc
Miami, Florida, United States
Allergy & Asthma Care of FL; Clinical Research
Ocala, Florida, United States
Emerald Coast Research Associates
Panama City, Florida, United States
Allergy & Asthma Diagnostic; Treatment Center
Tallahassee, Florida, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States
Southeastern Lung Care
Decatur, Georgia, United States
Atlanta Allergy & Asthma Clini
Woodstock, Georgia, United States
Laporte County Institute For Clinical Research
Michigan City, Indiana, United States
Iowa Clinical Research Corporation
Iowa City, Iowa, United States
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, United States
Infusion Associates
Grand Rapids, Michigan, United States
Midwest Clinical Research LLC
St Louis, Missouri, United States
Washington Univ. School of Med
St Louis, Missouri, United States
Montana Medical Research LLC
Missoula, Montana, United States
Heartland Clinical Research Inc.
Omaha, Nebraska, United States
Asthma & Allergy Center, P.C.
Papillion, Nebraska, United States
Allergy & Asthma Associates
Las Vegas, Nevada, United States
Allergy & Asthma Research of Nj, Inc
Mount Laurel, New Jersey, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, United States
Princeton Center For Clinical Research
Skillman, New Jersey, United States
North Shore University Hosp
New Hyde Park, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Allergy & Asthma Center of NC
High Point, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Asthma & Allergy Center
Toledo, Ohio, United States
Cor Clinical Research
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Allergy & Asthma Research Grp
Eugene, Oregon, United States
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, United States
Allergy Associates Research Center
Portland, Oregon, United States
Central PA Asth & Allergy Care; Research Division
Altoona, Pennsylvania, United States
Asthma Allergy Pulm Associates
Philadelphia, Pennsylvania, United States
Grand View Hospital; Clinical Research Department
Sellersville, Pennsylvania, United States
Asthma Allergy Phys of RI
Lincoln, Rhode Island, United States
ADAC Research PA
Greenville, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Tekton Research Inc
Austin, Texas, United States
TTS Research
Boerne, Texas, United States
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, United States
Allergy & Asthma Research Center of El Paso
El Paso, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, United States
Quality Assurance Research Ctr
San Antonio, Texas, United States
O & O Alpan, LLC
Fairfax, Virginia, United States
Clinical Research Partners, LLC
Henrico, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Bellingham Asthma, Allergy & Immunology
Bellingham, Washington, United States
ASTHMA, Inc
Seattle, Washington, United States
Marycliff Allergy Specialists
Spokane, Washington, United States
Dean Clinic
Madison, Wisconsin, United States
Fundación Faicep
Buenos Aires, , Argentina
Centro Médico Dra de Salvo
Buenos Aires, , Argentina
Instituto Ave Pulmo
Mar del Plata, , Argentina
Centro Respiratorio Quilmes
Quilmes, , Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, , Argentina
Liverpool Hospital
Liverpool BC, New South Wales, Australia
St. Vincent's Hospital Melbourne
Fitzroy, South Australia, Australia
Box Hill Hospital; Eastern Clinical Research Unit
Box Hill, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Alberta Health Services
Calgary, Alberta, Canada
Dr. E. Amer
Mississauga, Ontario, Canada
Inspiration Research Limited
Toronto, Ontario, Canada
Albion Finch Medical Centre
Toronto, Ontario, Canada
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec, Canada
Centro de Investigaciones Medicas Respiratorias
Santiago, , Chile
Schonffeldt y Guerrero Limitada
Santiago, , Chile
Hospital Carlos Van Buren
Valparaíso, , Chile
Fundacion Neumologica Colombiana
Bogota DC, , Colombia
Alergopraktik s.r.o.
Jablonec nad Nisou, , Czechia
Interni A Pneumologicka Ambulance
Jindřichův Hradec, , Czechia
MephaCentrum, a.s.
Ostrava - Poruba, , Czechia
Alergologie Teplice, s.r.o.
Teplice, , Czechia
Hopital Calmette; Pneumologie
Lille, , France
Hopital Nord; CIC
Marseille, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
CHU Nantes - Hôpital Laennec; Service de Pneumologie
Nantes, , France
Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
Strabourg, , France
Lungenarztpraxis Tegel
Berlin, , Germany
Pneumologisches Zentrum Wiesloch
Wiesloch, , Germany
Kenezy Korhaz Rendelointezet
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
C.C.C. Hospital Chest Diseases
Szeged, , Hungary
Barzilai Medical Center; Pulmonary Inst.
Ashkelon, , Israel
Lady Davis Carmel Medical Center; Cardiovascular Medicine
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center; Pulmonary Dept
Kfar Saba, , Israel
Kaplan Medical Center
Rehovot, , Israel
Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia
Cassano Murge (BA), Apulia, Italy
University of Catanzaro
Catanzaro, Calabria, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Torrette - Ancona, The Marches, Italy
A.o. Universitaria Pisana; Dipartimento Cardio Toracico
Pisa, Tuscany, Italy
Azienda Ospedaliera di Padova
Padua, Veneto, Italy
Tosei General Hospital; Respiratory and Allergy Medicine
Aichi, , Japan
Ofuji Clinic
Amagasaki-shi, , Japan
Kyushu Central Hospital
Fukuoka, , Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Oji General Hospital
Hokkaido, , Japan
National Hospital Organization Asahikawa Medical Center
Hokkaido, , Japan
Yokohama City Minato Red Cross Hospital
Kanagawa, , Japan
National Hospital Organization Tokyo National Hospital
Kiyose-shi, , Japan
Kochi Medical School Hospital
Kochi, , Japan
Oki Clinic
Kodaira-shi, , Japan
Takahashi Clinic
Kokubunji-shi, , Japan
Dokkyo Medical University Koshigaya Hospital
Koshigaya-shi, , Japan
Tono Chuo Clinic
Mizunami-shi, , Japan
Nagaoka Red Cross Hospital
Nagaoka-shi, , Japan
Niigata City General Hospital
Niigata, , Japan
Iwate Medical University Hospital
Numakunai, , Japan
Osaka City University Hospital
Osaka, , Japan
Touda Clinic
Osaka, , Japan
Kinki-Chuo Chest Medical Center
Osaka, , Japan
Senzoku Kokyuuki and Allergy Clinic
Ōta-ku, , Japan
Japan Community Health Care Organization Hokkaido Hospital
Sapporo, , Japan
Fukuwa Clinic
Tokyo, , Japan
Tokyo Center Clinic; Internal Medicine
Tokyo, , Japan
Sano Toranomon Clinic
Tokyo, , Japan
Showa University Hospital
Tokyo, , Japan
Teikyo University Hospital
Tokyo, , Japan
Sekino Hospital
Toshima City, , Japan
University of Fukui Hospital
Yoshida-gun, , Japan
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, , Mexico
Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC
Zapopan, , Mexico
NZ Respiratory & Sleep Institute
Auckland, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
RMC Medical Research Ltd
Dunedin, , New Zealand
P3 Research
Tauranga, , New Zealand
Centrum Medycyny Oddechowej Robert M. Mróz
Bialystok, , Poland
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bialystok, , Poland
Specjalistyczne Centrum Medyczne NOWOMED
Krakow, , Poland
Grazyna Pulka Specjalistyczny Ośrodek ALL-MED
Krakow, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, , Poland
Poradnia Pulmonologiczna dla Doroslych
Lódz, , Poland
Centrum Alergologii Teresa Hofman
Poznan, , Poland
SPZOZ Proszowice
Proszowice, , Poland
Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.
Skarżysko-Kamienna, , Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, , Poland
Klinika Chorób Wewnetrznych i Alergologii MSW
Warsaw, , Poland
ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, , Poland
Colentina Clinical Hospital
Bucharest, , Romania
Prof.Dr.Octavian Fodor Emergency Clinical Hospital
Cluj-Napoca, , Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
Craiova, , Romania
Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
Timișoara, , Romania
SIH Kemerovo Regional Clinical Hospital
Kemerovo, , Russia
Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
Moscow, , Russia
Central Clinical Hospital #1 of RZhD JCS
Moscow, , Russia
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, , Russia
Ryazan Regional Clinical Hosp
Ryazan, , Russia
City Outpatient Dept #94
Saint Petersburg, , Russia
St-Petersburg Diagnostic Ctr#1; Pulmonology
Saint Petersburg, , Russia
SHI Ctr Occupational Pathology
Saint Petersburg, , Russia
St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital
Saint Petersburg, , Russia
St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department
Saint Petersburg, , Russia
St. George the Martyr City Hospital
Saint Petersburg, , Russia
Smolensk State Medical Academy
Smolensk, , Russia
Tomsk Regional Clinical Hospital
Tomsk, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center Zvezdara
Belgrade, , Serbia
Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
Belgrade, , Serbia
Alian s.r.o.
Bardejov, , Slovakia
Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.
Bratislava, , Slovakia
Plucna ambulancia
Spišská Nová Ves, , Slovakia
Melomed Hospital Gatesville
Cape Town, , South Africa
Uni of Cape Town Lung Inst.
Cape Town, , South Africa
Vawda Z.Fa Practice
Durban, , South Africa
Gatesville Medical Centre
Gatesville, , South Africa
Deepak Lakha MBCHB Private Practice
Johannesburg, , South Africa
Botho ke Bontle Health Services
Pretoria, , South Africa
Dr Johannes Breedt; Emmed Research
Pretoria, , South Africa
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
St. Paul's Hospital, The Catholic University of Korea, College of Medicine
Seoul, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, Spain
Hospital de la Santa Creu; i Sant Pau
Barcelona, , Spain
Hospital Germans Trias i Pujol
Barcelona, , Spain
Hosp Univ Fundacion Alcorcon
Madrid, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
Ankara, , Turkey (Türkiye)
Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi
Ankara, , Turkey (Türkiye)
Uludag University; Pulmonology and Allergy Department
Bursa, , Turkey (Türkiye)
Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi
Çanakkale, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, , Turkey (Türkiye)
Kirikkale Universitesi Tip Fakultesi Hastanesi
Kırıkkale, , Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, , Turkey (Türkiye)
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnipro, , Ukraine
Educational Scientific Medical Centre of Donetsk National Medical University;
Donetsk, , Ukraine
Regional Phthisiology and Pulmonology Center
Ivano-Frankivsk, , Ukraine
City Clinical Hospital #27
Kharkiv, , Ukraine
Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy
Kharkiv, , Ukraine
Central Outpatient Hospital of Desnyansky District
Kyiv, , Ukraine
Yanovskyy Inst of Phth. & Pulm; Clinical-functional
Kyiv, , Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Kyiv City Clinical Hospital #8
Kyiv, , Ukraine
Danylo Halytskyy National Medical University; Lviv
Lviv, , Ukraine
Small Business Private Enterprise Medical Centre Pulse
Vinnytsia, , Ukraine
Municipal Institution of Health Care "Yevpatoriya City Hospital №1
Yevpatoria, , Ukraine
SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia
Zaporizhzhia, , Ukraine
St Peters Hospital
Chertsey, , United Kingdom
Castle Hill Hospital; Respiratory Medicine
Cottingham, , United Kingdom
Ninewells Hospital; Asthma and Allergy Research Group
Dundee, , United Kingdom
St James University Hospital; Respiratory Department
Leeds, , United Kingdom
University North Tees
Teesside, , 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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2013-000175-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB28688
Identifier Type: -
Identifier Source: org_study_id
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