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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01867125
Collaborator
(none)
1,081
230
3
41.1
4.7
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1081 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 31, 2013
Actual Primary Completion Date :
Jan 2, 2017
Actual Study Completion Date :
Jan 2, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lebrikizumab (125 mg)

Participants will receive SC injection of lebrikizumab (125 milligrams [mg]) every 4 weeks for 104 weeks.

Drug: Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Other Names:
  • RO5490255
  • Experimental: Lebrikizumab (37.5 mg)

    Participants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks.

    Drug: Lebrikizumab
    Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
    Other Names:
  • RO5490255
  • Drug: Placebo
    Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

    Placebo Comparator: 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.

    Drug: Lebrikizumab
    Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
    Other Names:
  • RO5490255
  • Drug: Placebo
    Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period [Baseline up to 52 weeks]

    Secondary Outcome Measures

    1. Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [Baseline, Week 52]

    2. Time to First Asthma Exacerbation [Baseline up to 52 weeks]

    3. Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score [Baseline, Week 52]

    4. Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments) [Baseline, Week 52]

    5. Rate of Urgent Asthma-Related Urgent Health Care Utilization [Baseline up to Week 52]

    6. Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab [Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)]

    7. Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score [Baseline, Week 52]

    8. Percentage of Participants With Adverse Events [Baseline, Week 124]

    9. Minimum Serum Concentration (Cmin) of Lebrikizumab [Predose (0 hour) on Weeks 4, 12, 24, 36, and 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Clinical Research Associates Pell City Alabama United States 35128
    2 Clinical Trial Connection Flagstaff Arizona United States 86001
    3 Desert Sun Clinical Research LLC Tucson Arizona United States 85710
    4 Allianz Medical and Research Center Fountain Valley California United States 92708
    5 Allergy & Asthma Medical Group & Research Center, Pc Long Beach California United States 90808
    6 Alliance Research LLC Long Beach California United States 90813
    7 Allergy Medical Clinic Los Angeles California United States 90025
    8 CA Allergy & Asthma Med Grp Los Angeles California United States 90025
    9 North Bay Clinical Trials Napa California United States 94558
    10 Choc Psf, Amc Orange California United States 92868
    11 Advances in Medicine Rancho Mirage California United States 92270
    12 Allergy Assoc Medical Group San Diego California United States 92108
    13 UCSF School of Medicine San Francisco California United States
    14 Bensch Research Associates Stockton California United States 95207
    15 IMMUNOe International Research Centers Centennial Colorado United States 80112
    16 Waterbury Pulmonary Associates Waterbury Connecticut United States 06708
    17 St. Francis Sleep; Allergy & Lung Institute Clearwater Florida United States 33765
    18 Creekside Medical Research DeLand Florida United States 32720
    19 Suncoast Research Group LLC Miami Florida United States 33135
    20 South Florida Research Phase I-IV, Inc Miami Florida United States 33165
    21 Allergy & Asthma Care of FL; Clinical Research Ocala Florida United States 34471
    22 Emerald Coast Research Associates Panama City Florida United States 32405
    23 Allergy & Asthma Diagnostic; Treatment Center Tallahassee Florida United States 32308
    24 Florida Pulmonary Research Institute, LLC Winter Park Florida United States 32789
    25 Southeastern Lung Care Decatur Georgia United States 30033
    26 Atlanta Allergy & Asthma Clini Woodstock Georgia United States 30188
    27 Laporte County Institute For Clinical Research Michigan City Indiana United States 46360
    28 Iowa Clinical Research Corporation Iowa City Iowa United States 52240
    29 Northeast Medical Research Associates, Inc North Dartmouth Massachusetts United States 02747
    30 Infusion Associates Grand Rapids Michigan United States 49525
    31 Midwest Clinical Research LLC Saint Louis Missouri United States 63141
    32 Washington Univ. School of Med Saint Louis Missouri United States 63141
    33 Montana Medical Research LLC Missoula Montana United States 59808
    34 Heartland Clinical Research Inc. Omaha Nebraska United States 68134
    35 Asthma & Allergy Center, P.C. Papillion Nebraska United States 68046
    36 Allergy & Asthma Associates Las Vegas Nevada United States 89104
    37 Allergy & Asthma Research of Nj, Inc Mount Laurel New Jersey United States 08054
    38 Atlantic Research Center, LLC Ocean City New Jersey United States 07712
    39 Princeton Center For Clinical Research Skillman New Jersey United States 08558
    40 North Shore University Hosp New Hyde Park New York United States 11042
    41 Montefiore Medical Center The Bronx New York United States 10461
    42 Allergy & Asthma Center of NC High Point North Carolina United States 27262
    43 PMG Research of Wilmington Wilmington North Carolina United States 28401
    44 Asthma & Allergy Center Toledo Ohio United States 43617
    45 Cor Clinical Research Oklahoma City Oklahoma United States 73103
    46 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    47 Allergy & Asthma Research Grp Eugene Oregon United States 97401-7721
    48 Clinical Research Inst. of Southern Oregon, Pc Medford Oregon United States 97504
    49 Allergy Associates Research Center Portland Oregon United States 97202
    50 Central PA Asth & Allergy Care; Research Division Altoona Pennsylvania United States 16601
    51 Asthma Allergy Pulm Associates Philadelphia Pennsylvania United States 19107
    52 Grand View Hospital; Clinical Research Department Sellersville Pennsylvania United States 18960
    53 Asthma Allergy Phys of RI Lincoln Rhode Island United States 02865
    54 ADAC Research PA Greenville South Carolina United States 29607
    55 Spartanburg Medical Research Spartanburg South Carolina United States 29303
    56 Tekton Research Inc Austin Texas United States 78717
    57 TTS Research Boerne Texas United States 78006
    58 Pharmaceutical Research & Consulting, Inc. Dallas Texas United States 75231
    59 Allergy & Asthma Research Center of El Paso El Paso Texas United States 79925
    60 Pioneer Research Solutions Houston Texas United States 77008
    61 Metroplex Pulmonology & Sleep Center McKinney Texas United States 75069
    62 Quality Assurance Research Ctr San Antonio Texas United States 78205
    63 O & O Alpan, LLC Fairfax Virginia United States 22030
    64 Clinical Research Partners, LLC Henrico Virginia United States 23233
    65 Manassas Clinical Research Center Manassas Virginia United States 20110
    66 Bellingham Asthma, Allergy & Immunology Bellingham Washington United States 98225
    67 ASTHMA, Inc Seattle Washington United States 98105
    68 Marycliff Allergy Specialists Spokane Washington United States 99204
    69 Dean Clinic Madison Wisconsin United States 53715
    70 Fundación Faicep Buenos Aires Argentina C1122AAK
    71 Centro Médico Dra de Salvo Buenos Aires Argentina C1426ABP
    72 Instituto Ave Pulmo Mar Del Plata Argentina CP 7600
    73 Centro Respiratorio Quilmes Quilmes Argentina 1878
    74 Investigaciones en Patologias Respiratorias San Miguel de Tucuman Argentina 4000
    75 Liverpool Hospital Liverpool BC New South Wales Australia 1871
    76 St. Vincent's Hospital Melbourne Fitzroy South Australia Australia 3065
    77 Box Hill Hospital; Eastern Clinical Research Unit Box Hill Victoria Australia 3128
    78 Western Hospital Footscray Victoria Australia 3011
    79 The Lung Institute of Western Australia; Sir Charles Gairdner Hospital Nedlands Western Australia Australia 6009
    80 Cliniques Universitaires St-Luc Bruxelles Belgium 1200
    81 UZ Gent Gent Belgium 9000
    82 Alberta Health Services Calgary Alberta Canada T2N 4N2
    83 Dr. E. Amer Mississauga Ontario Canada L5M 2V8
    84 Inspiration Research Limited Toronto Ontario Canada M5T 3A9
    85 Albion Finch Medical Centre Toronto Ontario Canada M9V4B4
    86 Centre d'investigation Clinique Mauricie Trois-Rivières Quebec Canada G8T 7A1
    87 Centro de Investigaciones Medicas Respiratorias Santiago Chile 7500692
    88 Schonffeldt y Guerrero Limitada Santiago Chile 7500698
    89 Hospital Carlos Van Buren Valparaiso Chile 2340000
    90 Fundacion Neumologica Colombiana Bogota DC Colombia 11001
    91 Alergopraktik s.r.o. Jablonec Nad Nisou Czechia 466 01
    92 Interni A Pneumologicka Ambulance Jindrichuv Hradec Czechia 377 38
    93 MephaCentrum, a.s. Ostrava - Poruba Czechia 708 68
    94 Alergologie Teplice, s.r.o. Teplice Czechia 415 01
    95 Hopital Calmette; Pneumologie Lille France 59037
    96 Hopital Nord; CIC Marseille France 13015
    97 Hôpital Arnaud de Villeneuve Montpellier France 34295
    98 CHU Nantes - Hôpital Laennec; Service de Pneumologie Nantes France 44093
    99 Nouvel Hôpital Civil; Pôle de Pathologie Thoracique Strabourg France 67091
    100 Lungenarztpraxis Tegel Berlin Germany 13507
    101 Pneumologisches Zentrum Wiesloch Wiesloch Germany 69168
    102 Kenezy Korhaz Rendelointezet Debrecen Hungary 4031
    103 Petz Aladar Megyei Oktato Korhaz Gyor Hungary 9024
    104 C.C.C. Hospital Chest Diseases Szeged Hungary 6722
    105 Barzilai Medical Center; Pulmonary Inst. Ashkelon Israel 78306
    106 Lady Davis Carmel Medical Center; Cardiovascular Medicine Haifa Israel 34362
    107 Shaare Zedek Medical Center Jerusalem Israel 91031
    108 Meir Medical Center; Pulmonary Dept Kfar Saba Israel 44281
    109 Kaplan Medical Center Rehovot Israel 7661041
    110 University of Catanzaro Catanzaro Calabria Italy 88100
    111 Azienda Ospedaliero Universitaria di Parma Parma Emilia-Romagna Italy 43100
    112 Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona Torrette - Ancona Marche Italy 60100
    113 Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia Cassano Murge (BA) Puglia Italy 70020
    114 A.o. Universitaria Pisana; Dipartimento Cardio Toracico Pisa Toscana Italy 56100
    115 Azienda Ospedaliera di Padova Padova Veneto Italy 35128
    116 Tosei General Hospital; Respiratory and Allergy Medicine Aichi Japan 489-8642
    117 Ofuji Clinic Amagasaki-shi Japan 660-0862
    118 Kyushu Central Hospital Fukuoka-shi Japan 815-8588
    119 National Hospital Organization Mito Medical Center Higashiibaraki-gun Japan 311-3193
    120 Hiroshima University Hospital Hiroshima Japan 734-8551
    121 Oji General Hospital Hokkaido Japan 053-8506
    122 National Hospital Organization Asahikawa Medical Center Hokkaido Japan 070-8644
    123 Iwate Medical University Hospital Iwate Japan 020-8505
    124 Yokohama City Minato Red Cross Hospital Kanagawa Japan 231-8682
    125 National Hospital Organization Tokyo National Hospital Kiyose-shi Japan 204-8585
    126 Kochi Medical School Hospital Kochi Japan 783-8505
    127 Oki Clinic Kodaira-shi Japan 187-0024
    128 Takahashi Clinic Kokubunji-shi Japan 185-0014
    129 Dokkyo Medical University Koshigaya Hospital Koshigaya-shi Japan 343-0845
    130 Tono Chuo Clinic Mizunami-shi Japan 509-6134
    131 Nagaoka Red Cross Hospital Nagaoka-shi Japan 940-2085
    132 Niigata City General Hospital Niigata-shi Japan 950-11977
    133 Osaka City University Hospital Osaka Japan 545-8586
    134 Touda Clinic Osaka Japan 589-0022
    135 Kinki-Chuo Chest Medical Center Osaka Japan 591-8555
    136 Senzoku Kokyuuki and Allergy Clinic Ota-ku Japan 145-0063
    137 Japan Community Health Care Organization Hokkaido Hospital Sapporo-shi Japan 062-8618
    138 Fukuwa Clinic Tokyo Japan 103-0027
    139 Tokyo Center Clinic; Internal Medicine Tokyo Japan 103-0028
    140 Sano Toranomon Clinic Tokyo Japan 105-0003
    141 Showa University Hospital Tokyo Japan 142-8666
    142 Teikyo University Hospital Tokyo Japan 173-8605
    143 Sekino Hospital Toshima Japan 171-0014
    144 University of Fukui Hospital Yoshida-gun Japan 910-1193
    145 Seoul National University Bundang Hospital Gyeonggi-do Korea, Republic of 13620
    146 Asan Medical Center Seoul Korea, Republic of 05505
    147 Samsung Medical Center Seoul Korea, Republic of 06351
    148 Korea University Guro Hospital Seoul Korea, Republic of 08308
    149 St. Paul's Hospital, The Catholic University of Korea, College of Medicine Seoul Korea, Republic of 130-709
    150 Wonju Christian Hospital Wonju Korea, Republic of 220-701
    151 Instituto Jalisciense de Investigacion Clinica S.A. de C.V. Guadalajara Mexico 44100
    152 Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC Zapopan Mexico 45200
    153 NZ Respiratory & Sleep Institute Auckland New Zealand 1051
    154 Dunedin Hospital Dunedin New Zealand
    155 RMC Medical Research Ltd Dunedin New Zealand
    156 P3 Research Tauranga New Zealand 3110
    157 Centrum Medycyny Oddechowej Robert M. Mróz Bialystok Poland 15-003
    158 Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Bialystok Poland 15-430
    159 Grazyna Pulka Specjalistyczny Ośrodek ALL-MED Krakow Poland 31-023
    160 Specjalistyczne Centrum Medyczne NOWOMED Kraków Poland 30-349
    161 Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k. Kraków Poland 31-637
    162 Poradnia Pulmonologiczna dla Doroslych Lódz Poland 90-153
    163 Centrum Alergologii Teresa Hofman Poznan Poland 60-214
    164 SPZOZ Proszowice Proszowice Poland 32-100
    165 Niepubliczny Specjalistyczny ZOZ Puls-Med s.c. Skarżysko-Kamienna Poland 26-110
    166 Medica Pro Familia Sp. z o.o. S.K.A. Warszawa Poland 01-868
    167 Klinika Chorób Wewnetrznych i Alergologii MSW Warszawa Poland 02-507
    168 ALL-MED Specjalistyczna Opieka Medyczna Wroclaw Poland 50-445
    169 Colentina Clinical Hospital Bucharest Romania 020125
    170 Prof.Dr.Octavian Fodor Emergency Clinical Hospital Cluj-Napoca Romania 400162
    171 Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova Craiova Romania 200515
    172 Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital Timisoara Romania 300310
    173 SIH Kemerovo Regional Clinical Hospital Kemerovo Russian Federation 650002
    174 Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases Moscow Russian Federation 117292
    175 Central Clinical Hospital #1 of RZhD JCS Moscow Russian Federation 125367
    176 Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2 Novosibirsk Russian Federation 630008
    177 Ryazan Regional Clinical Hosp Ryazan Russian Federation 390039
    178 St. George the Martyr City Hospital Saint Petersburg Russian Federation
    179 St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department Saint-Petersburg Russian Federation 197022
    180 Smolensk State Medical Academy Smolensk Russian Federation 4812
    181 City Outpatient Dept #94 St Petersburg Russian Federation 193231
    182 St-Petersburg Diagnostic Ctr#1; Pulmonology St. Petersburg Russian Federation 194354
    183 SHI Ctr Occupational Pathology St. Petersburg Russian Federation 195271
    184 St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital St. Petersburg Russian Federation 197022
    185 Tomsk Regional Clinical Hospital Tomsk Russian Federation 634063
    186 Clinical Center of Serbia Belgrade Serbia 11000
    187 Clinical Hospital Center Zvezdara Belgrade Serbia 11000
    188 Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology Belgrade Serbia 11080
    189 Alian s.r.o. Bardejov Slovakia 08501
    190 Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o. Bratislava Slovakia 831 03
    191 Plucna ambulancia Spisska Nova Ves Slovakia 052 01
    192 Melomed Hospital Gatesville Cape Town South Africa 7764
    193 Uni of Cape Town Lung Inst. Cape Town South Africa 7925
    194 Vawda Z.Fa Practice Durban South Africa 4091
    195 Gatesville Medical Centre Gatesville South Africa 7746
    196 Deepak Lakha MBCHB Private Practice Johannesburg South Africa 1820
    197 Botho ke Bontle Health Services Pretoria South Africa 0101
    198 Dr Johannes Breedt; Emmed Research Pretoria South Africa 84
    199 Hospital Universitario Araba Vitoria Alava Spain 01004
    200 Hospital de la Santa Creu; i Sant Pau Barcelona Spain 08025
    201 Hospital Germans Trias i Pujol Barcelona Spain 08916
    202 Hosp Univ Fundacion Alcorcon Madrid Spain 28922
    203 Hospital Virgen del Rocio Sevilla Spain 41013
    204 Hospital Universitario Doctor Peset Valencia Spain 46017
    205 Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi Ankara Turkey 06290
    206 Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi Ankara Turkey 06510
    207 Uludag University; Pulmonology and Allergy Department Bursa Turkey 16059
    208 Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi Canakkale Turkey 17110
    209 Ege University Medical Faculty Izmir Turkey 35100
    210 Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi Izmir Turkey 35110
    211 Kirikkale Universitesi Tip Fakultesi Hastanesi Kirikkale Turkey 71100
    212 Mersin University Medical Faculty Mersin Turkey 33169
    213 Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board Dnepropetrovsk Ukraine 49000
    214 Educational Scientific Medical Centre of Donetsk National Medical University; Donetsk Ukraine 83003
    215 Regional Phthisiology and Pulmonology Center Ivano-Frankivsk Ukraine 76018
    216 City Clinical Hospital #27 Kharkiv Ukraine 61002
    217 Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy Kharkiv Ukraine 61007
    218 Central Outpatient Hospital of Desnyansky District Kyiv Ukraine 02232
    219 Yanovskyy Inst of Phth. & Pulm; Clinical-functional Kyiv Ukraine 03680
    220 Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital Kyiv Ukraine 04107
    221 Kyiv City Clinical Hospital #8 Kyiv Ukraine 04201
    222 Danylo Halytskyy National Medical University; Lviv Lviv Ukraine 79010
    223 Small Business Private Enterprise Medical Centre Pulse Vinnytsya Ukraine 21001
    224 Municipal Institution of Health Care "Yevpatoriya City Hospital №1 Yevpatoriya Ukraine 97403
    225 SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia Zaporizhzhia Ukraine 69104
    226 St Peters Hospital Chertsey United Kingdom KT16 0PZ
    227 Castle Hill Hospital; Respiratory Medicine Cottingham United Kingdom HU16 5JQ
    228 Ninewells Hospital; Asthma and Allergy Research Group Dundee United Kingdom DD1 9SY
    229 St James University Hospital; Respiratory Department Leeds United Kingdom LS9 7TF
    230 University North Tees Teesside United Kingdom TS27

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01867125
    Other Study ID Numbers:
    • GB28688
    • 2013-000175-33
    First Posted:
    Jun 3, 2013
    Last Update Posted:
    May 19, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2017