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Igloo: Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza

Sponsor
Biota Scientific Management Pty Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT01793883
Collaborator
Department of Health and Human Services (U.S. Fed)
639
Enrollment
221
Locations
3
Arms
12
Duration (Months)
2.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

Condition or Disease Intervention/Treatment Phase
  • Drug: 40 mg Laninamivir Octanoate
  • Drug: 80 mg Laninamivir Octanoate
  • Drug: Placebo
 Phase 2

Detailed Description

Approximately 636 subjects will be randomized into the Study.

Following confirmation of circulating influenza in the local area, eligible subjects with recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will be randomized to placebo, 40 or 80 mg of laninamivir octanoate.

The study will be conducted on an outpatient basis. The first dose of study drug will be administered via inhalation within 4 hours of randomization in the clinic, followed by a second dose at home. Participants will be followed for 14 days to assess efficacy, virology and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.

Study Design

Study Type:
Interventional
Actual Enrollment :
639 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 40 mg Laninamivir Octanoate DPI

40 mg Laninamivir Octanoate and matching placebo

Drug: 40 mg Laninamivir Octanoate
Other Names:
  • CS-8958

    • Drug: Placebo
    Other Names:
  • Lactose

    		•
    Active Comparator: 80 mg Laninamivir Octanoate DPI

    80 mg Laninamivir

    Drug: 80 mg Laninamivir Octanoate
    Other Names:
  • CS-8958

    		•
    Placebo Comparator: Placebo

    Matching Placebo

    Drug: Placebo
    Other Names:
  • Lactose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Alleviation of Influenza Symptoms [Efficacy will be assessed over 14 days post-randomization.]

      Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Main Inclusion Criteria:

    1. Provide written informed consent

    2. Males or females aged 18-64 years, inclusive

    3. Symptomatic presumptive influenza A or B infection defined as the presence of:

    4. a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND

    5. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND

    6. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)

    7. Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred:

    8. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR

    9. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR

    10. time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)

    Main Exclusion Criteria:

    1. Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening

    2. Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks.

    3. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma

    4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months

    5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants

    6. Presence of clinically significant signs of acute respiratory distress during screening

    7. Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.

    8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min

    9. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scottsboro Quick Care Clinic Scottsboro Alabama United States 35768
    2 Clinical Trial Connection Camp Verde Arizona United States 86322
    3 Warner Family Practice Chandler Arizona United States 85224
    4 Clinical Research Connections, LLC Harrisburg Arkansas United States 72432
    5 NEA Baptist Clinic Jonesboro Arkansas United States 72401
    6 eStudySite Chula Vista California United States 91911
    7 Beach Physicians Medical Group, Inc. Huntington Beach California United States 92647
    8 eStudySite La Mesa California United States 91942
    9 Novo Research, Inc. Long Beach California United States 90813-3296
    10 Lucita M. Cruz, MD, Inc Norwalk California United States 90650
    11 eStudySite Oceanside California United States 92056
    12 Clinical Trials of Orange County, Inc Orange California United States 92868
    13 California Research Foundation San Diego California United States 92103-6204
    14 San Diego Sports Medicine & Family Health Center San Diego California United States 92120
    15 Orange County Research Center, Inc Tustin California United States 92780
    16 SC Clinical Research, Inc. Upland California United States 91786
    17 Complete Family Care Northglenn Colorado United States 80234
    18 BRCR Medical Center, Inc DBA Boca Raton Clinical Research Boca Raton Florida United States 33432
    19 Zasa Clinical Research, LLC Boynton Beach Florida United States 33437
    20 Southeast Clinical Research, LLC Chiefland Florida United States 32626
    21 Sanitas Research Coral Gables Florida United States 33134
    22 Southeast Clinical Research, LLC - Parent Jacksonville Florida United States 32216
    23 Crystal Biomedical Research Miami Lakes Florida United States 33014
    24 Columbus Clinical Services, LLC Miami Florida United States 33174
    25 New Horizon Research Center, Inc Miami Florida United States 33175
    26 DCT - FMC, LLC, d/b/a Discovery Clinical Trials Orlando Florida United States 32806
    27 Advanced Medical Research Center Port Orange Florida United States 32127
    28 Dr. B. Abraham, PC Snellville Georgia United States 30039
    29 Women's Healthcare Associates P.A. Idaho Falls Idaho United States 83404
    30 Baptist Health Clinical Studies Madisonville Kentucky United States 42431-1665
    31 Clinical Trials Management, LLC Mandeville Louisiana United States 70471
    32 Clinical Trials Management, LLC Metairie Louisiana United States 70006
    33 Medipharmics, LLC Metairie Louisiana United States 70006
    34 KAMP Medical Research Natchitoches Louisiana United States 71457
    35 Paul Shapero, MD Bangor Maine United States 04401
    36 Bethesda Allergy, Asthma & Research Center, LLC Bethesda Maryland United States 20814
    37 Neccr Imca, Llc Fall River Massachusetts United States 02720
    38 University of Massachusetts Medical Center Worcester Massachusetts United States 01655
    39 Oakland Medical Research Center Troy Michigan United States 48085
    40 Olive Branch Family Medical Center Olive Branch Mississippi United States 38654
    41 Pioneer Clinical Research, LLC Bellevue Nebraska United States 68005
    42 The Asthma & Allergy Center, P.C. master Bellevue Nebraska United States 68123-4303
    43 Beacom Family Health Connection Fremont Nebraska United States 68025
    44 eStudySite Las Vegas Nevada United States 89109
    45 Comprehensive Clinical Research Berlin New Jersey United States 08009
    46 PMG Research of Hickory, LLC Hickory North Carolina United States 28602
    47 Sentral Clinical Research Services, LLC Cincinnati Ohio United States 45236
    48 Hometown Urgent Care & Occupational Health Milford Ohio United States 45150
    49 ProMedica Health System, Inc Sylvania Ohio United States 43560
    50 Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma United States 74136
    51 Detweiler Family Medicine & Associates Lansdale Pennsylvania United States 19446
    52 Warminster Medical Associates, PC Warminster Pennsylvania United States 18974
    53 AAPRI Clinical Research Institute Warwick Rhode Island United States 02886
    54 Hillcrest Clinical Research, LLC Simpsonville South Carolina United States 29681
    55 Clinical Research Solutions, PC Columbia Tennessee United States 38401
    56 HCCA Clinical Research Solutions Franklin Tennessee United States 37067
    57 Clinical Research Solutions, PC Franklin Tennessee United States 37604
    58 HCCA Clinical Research Solutions Jackson Tennessee United States 38305
    59 PMG Research of Knoxville Knoxville Tennessee United States 37912
    60 Clinical Research Solutions, PC Nashville Tennessee United States 37211
    61 Clinical Research Solutions, PC Smyrna Tennessee United States 37167
    62 ACRC Trials Plano Texas United States 75024
    63 Sun Research Institute, LLC San Antonio Texas United States 78215
    64 Oakwell Clinical Research San Antonio Texas United States 78218
    65 DBA Southwest Clinic San Antonio Texas United States 78221-1615
    66 DCT-Stone Oak, LLC dba Discovery Clinical Trials San Antonio Texas United States 78258
    67 Westside Medical Clinton Utah United States 84015
    68 Focus Clinical Research Draper Utah United States 84020
    69 J. Lewis Research - FirstMed East Salt Lake City Utah United States 84121
    70 Carilion Infectious Disease Roanoke Virginia United States 24014
    71 Dr Doong's Surgery Burwood New South Wales Australia
    72 Hyde Park Medical Sydney New South Wales Australia
    73 Westmead Hospital Wentworthville New South Wales Australia
    74 Cairns Base Hospital Cairns Queensland Australia
    75 Jimboomba Junction Family Practice & Skin Cancer Clinic Jimboomba Queensland Australia
    76 Mermaid Beach Medical Centre Mermaid Beach Queensland Australia
    77 Morayfield 7 Day Medical Centre Morayfield Queensland Australia
    78 AusTrials Pty Ltd. Sherwood Sherwood Queensland Australia
    79 Pain & Anaesthesia Research Clinic Adelaide South Australia Australia
    80 Hunter Clinical Research Broadmeadows Victoria Australia
    81 Dokter Luc Timmermans Borgerhout Belgium
    82 Vereecken Guy Halen Belgium
    83 Calozet, Yven Herbeumont Belgium
    84 Hutsebaut, Andre Moerkerke Belgium
    85 Van Mulders, Norbert Moorsel Belgium
    86 Parque, Jean-Luc Mouscron Belgium
    87 Mortelmans, Jaak Oostham Belgium
    88 Private Practice Oudenaarde Belgium
    89 BVBA Dr. Luc Capiau Wetteren Belgium
    90 SHATPPD-Ruse EOOD Ruse Bulgaria
    91 DCARC "Hill Clinic" Sofia Bulgaria
    92 Diagnostic Consultative Center II - Sofia OOD Sofia Bulgaria
    93 Fifth MHAT-Sofia, EAD Sofia Bulgaria
    94 MHAT "Lyulin", EAD Sofia Bulgaria
    95 Military Medical Academy - MHAT - Sofia Sofia Bulgaria
    96 NMTH "Tsar Boris III" Sofia Bulgaria
    97 UMHAT " Alexandrovska" EAD Sofia Bulgaria
    98 UMHAT 'Lozenets" Sofia Bulgaria
    99 MDHAT Dr Stefan Cherkezov, AD Veliko Tarnovo Bulgaria
    100 Aggarwal and Associates Ltd Brampton Ontario Canada
    101 Dr. Anil K. Gupta Medicine Professional Corporation Etobicoke Ontario Canada
    102 SKDS Research Inc. Newmarket Ontario Canada
    103 Omnispec Clinical Research Inc Mirabel Quebec Canada
    104 Clinique Medicale St-Louis (Recherche) Inc Quebec Canada
    105 Administradora Country S.A. Bogota Colombia
    106 Centro de Investigacion Clinica - CAFAM Bogota Colombia
    107 Clinica Colsanitas S.A. sede Clinica Universitaria Columbia Bogota Colombia
    108 Vee Family Doctor's Center OY Paide Estonia
    109 Medicum Perearstikeskus AS Tallinn Estonia
    110 Meie Tervis OU Tallinn Estonia
    111 Merekivi Perearstid OU Tallinn Estonia
    112 Merelahe Family Doctors Centre Tallinn Estonia
    113 Mustamae Health Centre Tallinn Estonia
    114 Pirita Family Doctors Centre Tallinn Estonia
    115 Dr Monika Vask Ltd. Tartu Estonia
    116 Marje Toom Family Doctors Practice Voru Estonia
    117 Cabinet Medical La Bouexiere Ille Et Vilaine France
    118 Cabinet Medical Tours Indre Et Loire France
    119 Cabinet Medical La Montagne Loire Atlantique France
    120 Cabinet Medical - Alain Boye Nantes Loire Atlantique France
    121 Cabinet Medical Briollay Maine Et Loire France
    122 Cabinet Medical Jacques Marty Murs-Erigne Maine Et Loire France
    123 Cabinet Medical Jean Charcot Segre Maine Et Loire France
    124 Cabinet Medical Vihiers France
    125 Institut fuer Praeventive Medizin Freiburg Freiburg Baden Wuerttemberg Germany
    126 Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz Dietzenbach Hessen Germany
    127 Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff Essen Nordrhein Westfalen Germany
    128 Hausarztzentrum Bocholder Strasse Essen Nordrhein Westfalen Germany
    129 Medizentrum Essen Borbeck Essen Nordrhein Westfalen Germany
    130 Unterfrintroper Hausarztzentrum Essen Nordrhein Westfalen Germany
    131 medicoKIT Goch Nordrhein Westfalen Germany
    132 Gemeinschaftspraxis Heisters und Sungen Kamp-Lintfort Nordrhein Westfalen Germany
    133 Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen Koein Nordrhein Westfalen Germany
    134 ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH Dresden Sachsen Germany
    135 Praxis Dr. Schiewe Hamburg Germany
    136 Clinexpert Egeszsegugyi Szolg. es Ker. Kft. Budapest Hungary
    137 CSALADGYOGYYASZ Szolgaltato es Oktato Bt. Budapest Hungary
    138 Haziorvosi Rendelo Budapest Hungary
    139 QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft Budapest Hungary
    140 Kenezy Korhaz es Rendelointezet Debrecen Hungary
    141 Bekes Megyei Pandy Kalman Korhaz Gyula Hungary
    142 Felnott Haziorvosi Rendelo Kecskemet Hungary
    143 Haziorvosi Rendelo Kecskemet Hungary
    144 Felnott Haziorvosi Rendelo Miskolc Hungary
    145 Revamed Kft. Nyiregyhaza Hungary
    146 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar Hungary
    147 Liga Kozlovska Family Doctor Practice Balvi Latvia
    148 Jelgava Outpatient Clinic Jelgava Latvia
    149 Dr. R. Eglite's Private Practice Kuldiga Latvia
    150 Dr. Dz.Trosk's practice Lielvarde Latvia
    151 Regional Hospital of Liepaja Liepaja Latvia
    152 Hospital of Reseknes Rezekne Latvia
    153 Clinic of GP A.Lasmanis "ALMA" Riga Latvia
    154 Vecverdina Vizma - GP Practice Riga Latvia
    155 Centro de Investigacion Clinica Acelerada, S.C. Mexico Distrito Federal Mexico
    156 Centro de Investigacion Clinica GRAMEL S.C Mexico Distrito Federal Mexico
    157 Facultad Mexicana de Medicina, Universidad La Salle A.C. Mexico Distrito Federal Mexico
    158 Hospital Angeles Lindavista Mexico Distrito Federal Mexico
    159 Mexico Centre for Clinical Research S.A. de C.V Mexico Distrito Federal Mexico
    160 Phylasis Clinicas Research S de RL de CV Cuautitlan Izcalli Estado De Mexico Mexico
    161 Clinical Research Institute S.C. Tlalnepantla Estado De Mexico Mexico
    162 Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA) Guadalajara Jalisco Mexico
    163 Hospital de Especialidades Centro Medico Puerta de Hierro Zapopan Jalisco Mexico
    164 Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey Monterrey Nuevo Leon Mexico
    165 Hospital Universitario de Monterrey Monterrey Nuevo Leon Mexico
    166 Nucleo Victoria de Investigacion Clinica S.C. Durango Mexico
    167 Oaxaca Site Management Organization S.C. Oaxaca Mexico
    168 Optimal Clinical Trials Auckland New Zealand
    169 Primorus Clinical Trials Ltd Christchurch New Zealand
    170 Shirley Medical Centre Christchurch New Zealand
    171 Clinical Trials New Zealand Ltd Hamilton New Zealand
    172 Auckland Family Medical Centre Remuera New Zealand
    173 Hospital Nacional Carlos Alberto Seguin Escobedo Arequipa Peru
    174 Hospital Nacional Adolfo Guevara Velasco Cusco Peru
    175 Clinica Internacional Sede San Borja Lima Peru
    176 Clinica San Borja Lima Peru
    177 Hospital Maria Auxiliadora Lima Peru
    178 Hospital Nacional Arzobispo Loayza Lima Peru
    179 Global Clinical Trials PE Port Elizabeth Eastern Cape South Africa
    180 Iatros International Bloemfontein Free State South Africa
    181 Josha Research Bloemfontein Free State South Africa
    182 Drs YAK Vahed and Partners Welkom Free State South Africa
    183 Maphutha, MB Johannesburg Gauteng South Africa
    184 Medicross Roodepoort Clinical Research Johannesburg Gauteng South Africa
    185 Clinresco Centres (Pty) Ltd Kempton Park Gauteng South Africa
    186 DJW Research Krugersdorp Gauteng South Africa
    187 Synexus SA, Stanza Bopape Clinical Research Centre Mamelodi East Gauteng South Africa
    188 Emmed Research Pretoria Gauteng South Africa
    189 Engelbrecht, I Pretoria Gauteng South Africa
    190 Global Clinical Trials Pretoria Pretoria Gauteng South Africa
    191 Jongaie Research Pretoria Gauteng South Africa
    192 Synexus SA - Watermeyer Clinical Research Centre Pretoria Gauteng South Africa
    193 Syzygy Clinical Research Services Wilgers Pretoria Gauteng South Africa
    194 University of Pretoria Clinical Research Unit Pretoria Gauteng South Africa
    195 De Villiers Clinical Trials Durban KwaZulu-Natal South Africa
    196 Sebastian, Peter Durban KwaZulu-Natal South Africa
    197 Synapta Clinical Research Durban KwaZulu-Natal South Africa
    198 van Rensburg, CJJ Durban KwaZulu-Natal South Africa
    199 Vawda, ZFA Durban KwaZulu-Natal South Africa
    200 Brookdale Clinical Research Centre Phoenix KwaZulu-Natal South Africa
    201 Richards Bay Trial Centre (Pty) Ltd Richards Bay KwaZulu-Natal South Africa
    202 Aliwal Shoal Medical Centre Umkomaas KwaZulu-Natal South Africa
    203 Limpopo Clinical Research Initiative Thabazimbi Limpopo South Africa
    204 Mzansi Ethical Research Centre Middelburg Mpumalanga South Africa
    205 Africa International Research Cape Town Western Cape South Africa
    206 Allergy Diagnostic & Clinical Research Unit Cape Town Western Cape South Africa
    207 Boyd, WV Cape Town Western Cape South Africa
    208 Helderberg Clinical Trials Centre Cape Town Western Cape South Africa
    209 Langeberg Clinical Trials Cape Town Western Cape South Africa
    210 Tiervlei Trial Centre Cape Town Western Cape South Africa
    211 Western Cape Clinical Trials Cape Town Western Cape South Africa
    212 Excellentis Clinical Trial Consultants George Western Cape South Africa
    213 Somerset West Clinical Trial Unit Somerset West Western Cape South Africa
    214 Clinical Projects Research SA (PTY) LTD Worcester Western Cape South Africa
    215 Staploe Medical Centre Ely Cambridgeshire United Kingdom
    216 Avondale Surgery Research Chesterfield Derbyshire United Kingdom
    217 Knowle House Surgery Plymouth Devon United Kingdom
    218 Sheepcot Medical Centre Watford Hertfordshire United Kingdom
    219 CPS Ltd Glasgow Strathclyde United Kingdom
    220 Holbrook Lane Surgery Coventry Warwickshire United Kingdom
    221 Bradford on Avon Health Centre Bradford-on-Avon Wiltshire United Kingdom

    Sponsors and Collaborators

    • Biota Scientific Management Pty Ltd
    • Department of Health and Human Services

    Investigators

    • Study Director: John Lambert, PhD, Biota Scientific Management Pty Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biota Scientific Management Pty Ltd
    ClinicalTrials.gov Identifier:
    NCT01793883
    Other Study ID Numbers:
    • BTA51-350-201
    • HHSO100201100019C
    • 2013-000582-36
    First Posted:
    Feb 18, 2013
    Last Update Posted:
    May 31, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by Biota Scientific Management Pty Ltd
    Influenza Laninamivir Octanoate
    Additional relevant MeSH terms:
    Influenza, Human
    Laninamivir
    Zanamivir

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
    Arm/Group Description 40 mg Laninamivir Octanoate and matching placebo 40 mg Laninamivir Octanoate Placebo 80 mg Laninamivir 80 mg Laninamivir Octanoate Matching Placebo Placebo
    Period Title: Overall Study
    STARTED 213 214 212
    COMPLETED 201 204 204
    NOT COMPLETED 12 10 8

    Baseline Characteristics

    Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo Total
    Arm/Group Description 40 mg Laninamivir Octanoate and matching placebo 40 mg Laninamivir Octanoate Placebo 80 mg Laninamivir 80 mg Laninamivir Octanoate Matching Placebo Placebo Total of all reporting groups
    Overall Participants 213 214 212 639
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.5
    (11.95)
    39.2
    (12.49)
    40.3
    (13.31)
    39.3
    (12.60)
    Sex: Female, Male (Count of Participants)
    Female
    119
    55.9%
    128
    59.8%
    115
    54.2%
    362
    56.7%
    Male
    94
    44.1%
    86
    40.2%
    97
    45.8%
    277
    43.3%
    Region of Enrollment (participants) [Number]
    Hungary
    1
    0.5%
    1
    0.5%
    1
    0.5%
    3
    0.5%
    United States
    102
    47.9%
    97
    45.3%
    84
    39.6%
    283
    44.3%
    United Kingdom
    1
    0.5%
    0
    0%
    0
    0%
    1
    0.2%
    New Zealand
    2
    0.9%
    4
    1.9%
    3
    1.4%
    9
    1.4%
    Canada
    2
    0.9%
    2
    0.9%
    3
    1.4%
    7
    1.1%
    Latvia
    1
    0.5%
    3
    1.4%
    4
    1.9%
    8
    1.3%
    Belgium
    13
    6.1%
    8
    3.7%
    14
    6.6%
    35
    5.5%
    Mexico
    7
    3.3%
    12
    5.6%
    10
    4.7%
    29
    4.5%
    South Africa
    40
    18.8%
    38
    17.8%
    39
    18.4%
    117
    18.3%
    Bulgaria
    27
    12.7%
    32
    15%
    36
    17%
    95
    14.9%
    Germany
    6
    2.8%
    4
    1.9%
    3
    1.4%
    13
    2%
    Estonia
    11
    5.2%
    13
    6.1%
    15
    7.1%
    39
    6.1%

    Outcome Measures

    1. Primary Outcome
    Title Time to Alleviation of Influenza Symptoms
    Description Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.
    Time Frame Efficacy will be assessed over 14 days post-randomization.

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat-infected (ITT-I) population - all ITT subjects with laboratory confirmed influenza A or B infection by at least one virological method (qRT-PCR or qCulture) on either Day 1 or 3
    Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
    Arm/Group Description 40 mg Laninamivir Octanoate and matching placebo 40 mg Laninamivir Octanoate Placebo 80 mg Laninamivir 80 mg Laninamivir Octanoate Matching Placebo Placebo
    Measure Participants 67 75 89
    Median (95% Confidence Interval) [hours]
    102.30
    103.20
    104.10
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 40 mg Laninamivir Octanoate DPI, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.251
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 80 mg Laninamivir Octanoate DPI, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.818
    Comments
    Method Log Rank
    Comments

    Adverse Events

    Time Frame Period of time was defined as from Day 1 to Day 15.
    Adverse Event Reporting Description All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
    Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
    Arm/Group Description 40 mg Laninamivir Octanoate and matching placebo 40 mg Laninamivir Octanoate Placebo 80 mg Laninamivir Octanoate 80 mg Laninamivir Octanoate Matching Placebo Placebo
    All Cause Mortality
    40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/213 (0%) 0/214 (0%) 0/212 (0%)
    Serious Adverse Events
    40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/212 (0.5%) 1/211 (0.5%) 1/211 (0.5%)
    Gastrointestinal disorders
    Gastritis 1/212 (0.5%) 1 0/211 (0%) 0 0/211 (0%) 0
    Infections and infestations
    Bronchitis bacterial 1/212 (0.5%) 1 0/211 (0%) 0 0/211 (0%) 0
    Gastroenteritis bacterial 0/212 (0%) 0 1/211 (0.5%) 1 0/211 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumomediastinum 0/212 (0%) 0 0/211 (0%) 0 1/211 (0.5%) 1
    Other (Not Including Serious) Adverse Events
    40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 31/212 (14.6%) 27/211 (12.8%) 21/211 (10%)
    Gastrointestinal disorders
    Diarrhoea 8/212 (3.8%) 6/211 (2.8%) 2/211 (0.9%)
    Infections and infestations
    Bronchitis bacterial 6/212 (2.8%) 6/211 (2.8%) 9/211 (4.3%)
    Urinary tract infection 1/212 (0.5%) 7/211 (3.3%) 1/211 (0.5%)
    Nervous system disorders
    Headache 7/212 (3.3%) 2/211 (0.9%) 3/211 (1.4%)
    Respiratory, thoracic and mediastinal disorders
    Cough 10/212 (4.7%) 4/211 (1.9%) 6/211 (2.8%)
    Nasal congestion 9/212 (4.2%) 5/211 (2.4%) 3/211 (1.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Anna Novotney-Barry
    Organization Aviragen Therapeutics, Inc.
    Phone 678-221-3356
    Email abarry@aviragentherapeutics.com
    Responsible Party:
    Biota Scientific Management Pty Ltd
    ClinicalTrials.gov Identifier:
    NCT01793883
    Other Study ID Numbers:
    • BTA51-350-201
    • HHSO100201100019C
    • 2013-000582-36
    First Posted:
    Feb 18, 2013
    Last Update Posted:
    May 31, 2018
    Last Verified:
    May 1, 2018