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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01868061
Collaborator
(none)
1,068
Enrollment
232
Locations
3
Arms
41.1
Actual Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1068 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 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

    		•
    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 Week 52]

    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 Week 52]

    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 Adverse Events [Baseline up to Week 124]

    7. 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)]

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

    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of Alabama, LLC Birmingham Alabama United States 35209
    2 Medical Research of Arizona; Allergy, Asthma & Immu Scottsdale Arizona United States 85251
    3 Quality of Life Medical & Research Center Tucson Arizona United States 85712
    4 Kern Allergy Med Clinic, Inc. Bakersfield California United States 93301
    5 Allergy and Asthma Relief Experts Granada Hills California United States 91344
    6 Southern California Institute For Respiratory Los Angeles California United States 90048
    7 Allergy & Asthma Consultants Redwood City California United States 94063
    8 Integrated Research Group Inc Upland California United States 91786
    9 Allergy & Asthma Medical Group; Clinical Research Division Walnut Creek California United States 94598
    10 Asthma & Allergy; Associates, P.C. Colorado Springs Colorado United States 80907
    11 Storms Clinical Research; Institute Colorado Springs Colorado United States 80907
    12 National Jewish Health Denver Colorado United States 80206
    13 Colorado Allergy & Asthma Centers, Pc Denver Colorado United States 80230
    14 Western States Clinical Research, Inc Wheat Ridge Colorado United States 80033
    15 Yale University School Of Medicine New Haven Connecticut United States 06510
    16 Allergy Consultants PA Boca Raton Florida United States 33431
    17 Research Institute of South Florida Inc Miami Florida United States 33173
    18 Sarasota Clinical Research Sarasota Florida United States 34239
    19 Georgia Pollens Albany Georgia United States 31707
    20 Brookstone Clinical Res Ctr Columbus Georgia United States 31904
    21 Southeast Regional Research Group Columbus Georgia United States 31904
    22 DataQuest Medical Research Lawrenceville Georgia United States 30045
    23 Aeroallergy Research Labs Savannah Georgia United States 31406
    24 Atlanta Allergy & Asthma Clini Woodstock Georgia United States 30188
    25 East-West Medical Research Institute Honolulu Hawaii United States 96814
    26 Asthma & Allergy of Idaho Twin Falls Idaho United States 83301
    27 The Allergy and Asthma Center Fort Wayne Indiana United States 46804
    28 Cotton O'Neil Clinic; Stormont-Vail Hlth Care Topeka Kansas United States 66606
    29 Dr. Paul Shapero Bangor Maine United States 04401
    30 Asthma, Allergy & Sinus Center Baltimore Maryland United States 21236
    31 Chesapeake Clinical Research Baltimore Maryland United States 21236
    32 Howard County Center for Lung and Sleep, LLC Columbia Maryland United States 21044
    33 Infinity Medical Research Inc North Dartmouth Massachusetts United States 02747
    34 Clinical Research Inst Minneapolis Minnesota United States 55402
    35 Asthma and Allergy Physicians LLC Brockton Mississippi United States 02301
    36 Allergy Associates, Inc. Chesterfield Missouri United States 63017
    37 Center For Pharmaceutical Research Kansas City Missouri United States 64114
    38 Clinical Research Center, L.L.C. Saint Louis Missouri United States 63141
    39 Clinical Research Consortium Las Vegas Nevada United States 89119
    40 Adult Pediatric Allergy Central Jersey Edison New Jersey United States 08820
    41 Patrick V. Perin, MD Teaneck New Jersey United States 07666
    42 University of New Mexico; School of Med Albuquerque New Mexico United States 87131
    43 Winthrop Univ Hospital Mineola New York United States 11501
    44 Allergy Partners of Western NC Asheville North Carolina United States 28801
    45 Allergy & Asthma Centre of Dayton Centerville Ohio United States 45458
    46 Integrity People Services Research Company Oklahoma City Oklahoma United States 73103
    47 Oklahoma Institute of Allergy and Asthma Clinical Research LLC Oklahoma City Oklahoma United States 73131
    48 Vital Prospects Clin Res Pc Tulsa Oklahoma United States 74136
    49 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    50 Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania United States 15241
    51 Asthma and Allergy Research Associates Upland Pennsylvania United States 19013
    52 Neem Research Group, Inc. Columbia South Carolina United States 29201
    53 Greenville Pharmaceutical Research Greenville South Carolina United States 29615
    54 Upstate Pharmaceutical Research; Greenville Greenville South Carolina United States 29615
    55 Future Search Clinical Trials L.P. Austin Texas United States 78756
    56 Elliot J. Ginchansky, MD, PA Dallas Texas United States 75230
    57 EPIMRD, Inc. DBA Western Sky Medical Research El Paso Texas United States 79903
    58 Baylor College of Medicine; Dept of Medicine Houston Texas United States 77030
    59 Allergy & Asthma Clin Cen TX Round Rock Texas United States 78681
    60 Quality Assurance Research Ctr San Antonio Texas United States 78205
    61 Discovery Clinical Trials San Antonio Texas United States 78224
    62 Allergy & Asthma Research Center San Antonio Texas United States 78229
    63 Live Oak Allergy & Asthma Clinic San Antonio Texas United States 78233
    64 Allergy Associates of Utah Murray Utah United States 84107
    65 Pulmonary Research of Albingdon Abingdon Virginia United States 24210
    66 University of Wisconsin;Allergy & Asthma Clinical Research Madison Wisconsin United States 53792
    67 Instituto de Investigaciones Clinicas-Mar del Plata Buenos Aires Argentina B7600FZN
    68 Fundacion Cidea Buenos Aires Argentina C1125 ABE
    69 Centro Respiratorio Infantil Rosario Argentina 2000
    70 Centro Modelo de Cardiologia San Miguel de Tucuman Argentina 4000
    71 CEMER Centro Médico de Enfermedades Respiratorias Vicente López Argentina B1602DQD
    72 Concord Repatriation General Hospital; Department Thoracic Medicine Sydney New South Wales Australia 2139
    73 AusTrials Brisbane Queensland Australia 4075
    74 Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine Brisbane Queensland Australia 4102
    75 Respiratory Clinical Trials Pty Ltd Toorak Gardens South Australia Australia 5065
    76 The Lung Institute of Western Australia; Sir Charles Gairdner Hospital Nedlands Western Australia Australia 6009
    77 Private Practice Jambes Belgium 5100
    78 UZ Leuven Gasthuisberg Leuven Belgium 3000
    79 Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases Ruse Bulgaria 7002
    80 Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD Smolyan Bulgaria 4700
    81 5TH MHAT; Pulmonology Sofia Bulgaria 1233
    82 National Multiprofile Hospital Tsar Boris III Sofia Bulgaria 1233
    83 Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases Sofia Bulgaria 1431
    84 SHATPD Sveta Sofia; Clin Pulmonary Diseases Sofia Bulgaria 1431
    85 Alitera - Med - Medical Center EOOD Sofia Bulgaria 1618
    86 Multiprofile Hospital For Active Treatment prof Kirkovich Stara Zagora Bulgaria 6003
    87 Diagnostic and Consulting Centre Mladost - M OOD Varna Bulgaria 9020
    88 Medical Center Tara OOD Veliko Tarnovo Bulgaria 5000
    89 Cheema Research, Inc Mississauga Ontario Canada L5A 3V4
    90 Ottawa Allergy Research Corp Ottawa Ontario Canada K1Y 4G2
    91 Manna Research Toronto Ontario Canada M9W 4L6
    92 Dr Anil Dhar Professional Medicine Corporation Windsor Ontario Canada N8X-5A6
    93 Del Carpio Jaime Dr - Allergiste & Immunologue Montreal Quebec Canada H3H 1T8
    94 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    95 Thomayerova nemocnice Praha 4 - Krc Czechia 140 59
    96 Ordinace pro tuberkulozu a respiracni nemoci Strakonice Czechia 38601
    97 KASMED, s.r.o.; Alergologie a klinicka imunologie Tabor Czechia 390 01
    98 Centre Hospitalier Universitaire de Bicêtre Le Kremlin-bicêtre France 94275
    99 Hôpital de La Croix Rousse Lyon France 69004
    100 Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon Paris France 75014
    101 Hopital Bichat Claude Bernard ; Service de Pneumologie Paris France 75877
    102 Medaimun GmbH Frankfurt am Main Germany 60596
    103 Pneumologisches Forschungsinstitut Großhansdorf Germany 22927
    104 Praxis Dr. med. Hermann A. Trauth Marburg Germany 35037
    105 Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika Debrecen Hungary 4032
    106 Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés Komárom Hungary 2900
    107 Markusovszky Egyetemi Oktatokorhaz Szombathely Hungary 9700
    108 Rambam Health Care Campus Haifa Israel 31096
    109 Hadassah Medical Center; Pulmonary Institute Jerusalem Israel 9112001
    110 Nazareth EMMS Hospital Nazareth Israel 16100
    111 Rabin Medical Center Petach Tikva Israel 49100
    112 Chaim Sheba Medical Center; Oncology Dept Ramat Gan Israel 5262100
    113 Azienda Ospedaliera Monaldi Napoli Campania Italy 80131
    114 Azienda Ospedaliera Universitaria di Modena Modena Emilia-Romagna Italy 41100
    115 Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli Rome Lazio Italy 00168
    116 Asst Santi Paolo E Carlo Milano Lombardia Italy 20142
    117 Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria Pavia Lombardia Italy 27100
    118 P.O. Citta' Di Sesto S. Giovanni Sesto San Giovanni Lombardia Italy 20099
    119 Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia Catania Sicilia Italy 95123
    120 Banbuntane Hotokukai Hospital Aichi Japan 454-8509
    121 Fukuoka National Hospital Fukuoka Japan 811-1394
    122 Hiroshima Allegy & Respiratory Clinic Hiroshima Japan 732-0052
    123 Ibarakihigashi National Hospital Ibaraki Japan 319-1113
    124 Uno Naikakokyukika Clinic Isesaki-shi Japan 372-0831
    125 Yokohama City University Medical Center; Neurology Kanagawa Japan 232-0024
    126 Sagamihara National Hospital Kanagawa Japan 252-0392
    127 Kumamoto Saishunso National Hospital Koshi-shi Japan 861-1196
    128 Kumamoto University Hospital Kumamoto Japan 860-8556
    129 Kyoto University Hospital, Respiratory Medicine Kyoto Japan 606-8507
    130 Machida Municipal Hospital Machida-shi Japan 194-0023
    131 Hikarigaoka Spellman Hospital; Rheumatology Miyagi Japan 983-0833
    132 Nagoya Ekisaikai Hospital Nagoya-shi Japan 454-8502
    133 Okayama University Hospital Okayama Japan 700-8558
    134 Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease Osaka Japan 569-1096
    135 Kinki University Hospital Osaka Japan 589-8511
    136 Kishiwada City Hospital Osaka Japan 596-8501
    137 Tohoku Medical and Pharmaceutical University Wakabayashi Hospital Sendai-shi Japan 984-8560
    138 Iwata City Hospital Shizuoka Japan 438-8550
    139 Takamatsu Municipal Hospital Takamatsu-shi Japan 760-8538
    140 Hanzomon Hospital Tokyo Japan 102-0083
    141 Tokyo-Eki Center-building Clinic Tokyo Japan 103-0027
    142 Center Hospital of the National Center for Global Health and Medicine Tokyo Japan 162-8655
    143 Nihon University Itabashi Hospital Tokyo Japan 173-8610
    144 Toyama City Hospital Toyama Japan 939-8511
    145 Chonnam National University Hospital Gwangju Korea, Republic of 61469
    146 Soonchunhyang University Bucheon Hospital Gyeonggi-do Korea, Republic of 14584
    147 Korea University Anam Hospital Seoul Korea, Republic of 02841
    148 Seoul St Mary's Hospital Seoul Korea, Republic of 06591
    149 Seoul National University Hospital; Division of Allergy and Clinical Immunology Seoul Korea, Republic of 110-744
    150 Ewha Womans University Medical Center Seoul Korea, Republic of 158-050
    151 Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. Guadalajara Mexico 44130
    152 Unidad de Investigacion Clinica En Medicina (Udicem) S.C. Monterrey Mexico 64718
    153 Consultorio Especialidad Alergologia Pediatrica Villahermosa Mexico 86035
    154 Greenlane Clinical Centre Auckland New Zealand 1051
    155 Canterbury Respiratory Research Group; Respiratory Christchurch New Zealand 8011
    156 P3 Research Tauranga New Zealand 3110
    157 Medical Research Inst. of New Zealand; Respiratory Wellington New Zealand
    158 Hospital Nacional Adolfo; Guevara Velasco Essalud Cusco Peru Cusco 84
    159 Hospital Nacional Luis N Saenz PNP Lima Peru Lima 11
    160 Clinica Internacional Lima Peru Lima 1
    161 ABK Reuma SRL- Medicentro BioCiencias Lima Peru Lima 21
    162 Centro de Investigación Ricardo Palma Lima Peru LIMA 27
    163 Instituto Peruano de Investigacion en Ciencias Medicas Lima Peru Lima 32
    164 Clinica San Pablo Lima Peru Lima 33
    165 Clinica San Borja Lima Peru Lima 41
    166 Clinica los Andes Miraflores Peru Lima 18
    167 SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce Bieńnkówka Poland 34-212
    168 GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne Krakow Poland 31-159
    169 SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Lodz Poland 90-153
    170 Specjalistyczna Poradnia Pulmonologiczna Ostrow Wielkopolski Poland 63-400
    171 Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic Pila Poland 64-920
    172 ABC-PULMO Poradnia Chorob Pluc Radom Poland 26-600
    173 Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala Ruda Śląska Poland 41-707
    174 Centrum Medyczne Ogrodowa Skierniewice Poland 96-100
    175 Alergo Medical Specjalistyczna Przychodnia Lekarska Tarnow Poland 33-100
    176 Lexmedica Wroclaw Poland 53-114
    177 Dobrostan Gabinety Lekarskie Wroclaw Poland 53-301
    178 NZOZ Lekarze Specjalisci Wroclaw Poland 54-239
    179 Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I Cluj-Napoca Romania 400371
    180 Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta Palazu Mare Romania 900002
    181 Targu Mures Clinical Emergency County Hospital Targu Mures Romania 540100
    182 Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital Timisoara Romania 300310
    183 City Clinical Hospital #13 Moscow Russian Federation 115280
    184 I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF Moscow Russian Federation 115446
    185 City Clinical Hospital #2 Novosibirsk Russian Federation 630051
    186 Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department Penza Russian Federation 440026
    187 Ryazan Regional Clinincal Cardiology Dispensary Ryazan Russian Federation 390026
    188 Saratov State Medical Univ; Clinical Immun & Allerg Saratov Russian Federation 410012
    189 Municipal Polyclinic #25 St Petersburg Russian Federation 193312
    190 St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth St. Petersburg Russian Federation 197022
    191 St. Petersburg State Medical University n.a. I.P. Pavlov St. Petersburg Russian Federation 197089
    192 City Hospital #40 of Resort Administrative District St. Petersburg Russian Federation 197706
    193 Siberian State Medical University Tomsk Russian Federation 634050
    194 Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital Yaroslavl Russian Federation 150002
    195 Yaroslavl State Medical Academy - Clinical Hospital #2 Yaroslavl Russian Federation 150010
    196 Clinical Center of Serbia Belgrade Serbia 11000
    197 Institute of Lung Diseases Vojvodina Sremska Kamenica Serbia 21204
    198 Clinical Hospital Centre Zemun Zemun Serbia 11080
    199 Pneumo-Alergo Centrum s.r.o. Bratislava Slovakia 821 06
    200 ZAPA JJ Sro Levice Slovakia 934 01
    201 Imunoalergologia Dzurilla s.r.o. Nitra Slovakia 949 01
    202 Respiratory Research Unit Cape Town South Africa 7505
    203 Tiervalei Trial Centre Cape Town South Africa 7530
    204 St Augustines Hospital; Infectoilogy Durban South Africa 4001
    205 Dr PJ Sebastian Durban South Africa 4092
    206 Limpopo Clinical Research Initiative; Tamboti Medical Centre Tabazimbi South Africa 0380
    207 Aliwal Shoal Medical Center Umkomaas South Africa 4170
    208 Clinical Projects Research Worcester South Africa 6850
    209 Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo Santiago de Compostela La Coruña Spain 15706
    210 Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología Majadahonda Madrid Spain 28222
    211 Hospital Universitario Virgen Macarena Seville Sevilla Spain 41071
    212 Instituto de Ciencias Medicas Alicante Spain 03004
    213 Hospital Clinic de Barcelona Barcelona Spain 08036
    214 Institut Catala de Serveis Medics Girona Spain 17005
    215 Hospital Universitario la Paz; Servicio de Alergologia Madrid Spain 28046
    216 Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases Kyiv Kiev Governorate Ukraine 02091
    217 Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council Cherkasy Ukraine 18009
    218 MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council Dnipropetrovsk Ukraine 49006
    219 Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1 Donetsk Ukraine 83114
    220 Municipal Institution of Health Care City Clinical Hospital #13 Kharkiv Ukraine 61035
    221 SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine Kharkiv Ukraine 61039
    222 SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine Kyiv Ukraine 03680
    223 City Hospital #1 Mykolaiv Ukraine 54003
    224 Municipal Institution Odesa Regional Clinical Hospital Odesa Ukraine 65025
    225 City Clinical Hospital No.1; Therap Ukr Med Stom Acad Poltava Ukraine 36038
    226 Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine Vinnytsya Ukraine 21029
    227 LLC Diaservis Zaporizhzhia Ukraine 69106
    228 Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9 Zaporizhzhye Ukraine 69063
    229 Raigmore Hospital Inverness United Kingdom IV2 3UV
    230 Royal Preston Hospital Preston United Kingdom PR2 9HT
    231 Royal Hallamshire Hospital; Department of Oncology Sheffield United Kingdom S10 2JF
    232 Southmead Hospital Westbury-on-Trym, Bristol United Kingdom BS10 5NB

    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:
    NCT01868061
    Other Study ID Numbers:
    • GB28689
    • 2013-000176-15
    First Posted:
    Jun 4, 2013
    Last Update Posted:
    May 19, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of May 19, 2017