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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Drug: Placebo; Drug: 40 mg Laninamivir Octanoate; Drug: 80 mg Laninamivir Octanoate

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 Type: Interventional
• Enrollment (Actual): 639
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Burwood, New South Wales, Australia
      • Dr Doong's Surgery
    • Sydney, New South Wales, Australia
      • Hyde Park Medical
    • Wentworthville, New South Wales, Australia
      • Westmead Hospital
  • Queensland
    • Cairns, Queensland, Australia
      • Cairns Base Hospital
    • Jimboomba, Queensland, Australia
      • Jimboomba Junction Family Practice & Skin Cancer Clinic
    • Mermaid Beach, Queensland, Australia
      • Mermaid Beach Medical Centre
    • Morayfield, Queensland, Australia
      • Morayfield 7 Day Medical Centre
    • Sherwood, Queensland, Australia
      • AusTrials Pty Ltd. Sherwood
  • South Australia
    • Adelaide, South Australia, Australia
      • Pain & Anaesthesia Research Clinic
  • Victoria
    • Broadmeadows, Victoria, Australia
      • Hunter Clinical Research
• Belgium
  • Borgerhout, Belgium
    • Dokter Luc Timmermans
  • Halen, Belgium
    • Vereecken Guy
  • Herbeumont, Belgium
    • Calozet, Yven
  • Moerkerke, Belgium
    • Hutsebaut, Andre
  • Moorsel, Belgium
    • Van Mulders, Norbert
  • Mouscron, Belgium
    • Parque, Jean-Luc
  • Oostham, Belgium
    • Mortelmans, Jaak
  • Oudenaarde, Belgium
    • Private Practice
  • Wetteren, Belgium
    • BVBA Dr. Luc Capiau
• Bulgaria
  • Ruse, Bulgaria
    • SHATPPD-Ruse EOOD
  • Sofia, Bulgaria
    • DCARC "Hill Clinic"
  • Sofia, Bulgaria
    • Diagnostic Consultative Center II - Sofia OOD
  • Sofia, Bulgaria
    • Fifth MHAT-Sofia, EAD
  • Sofia, Bulgaria
    • MHAT "Lyulin", EAD
  • Sofia, Bulgaria
    • Military Medical Academy - MHAT - Sofia
  • Sofia, Bulgaria
    • NMTH "Tsar Boris III"
  • Sofia, Bulgaria
    • UMHAT " Alexandrovska" EAD
  • Sofia, Bulgaria
    • UMHAT 'Lozenets"
  • Veliko Tarnovo, Bulgaria
    • MDHAT Dr Stefan Cherkezov, AD
• Canada
  • Quebec, Canada
    • Clinique Medicale St-Louis (Recherche) Inc
  • Ontario
    • Brampton, Ontario, Canada
      • Aggarwal and Associates Ltd
    • Etobicoke, Ontario, Canada
      • Dr. Anil K. Gupta Medicine Professional Corporation
    • Newmarket, Ontario, Canada
      • SKDS Research Inc.
  • Quebec
    • Mirabel, Quebec, Canada
      • Omnispec clinical research inc
• Colombia
  • Bogota, Colombia
    • Administradora Country S.A.
  • Bogota, Colombia
    • Centro de Investigacion Clinica - CAFAM
  • Bogota, Colombia
    • Clinica Colsanitas S.A. sede Clinica Universitaria Columbia
• Estonia
  • Paide, Estonia
    • Vee Family Doctor's Center OY
  • Tallinn, Estonia
    • Pirita Family Doctors Centre
  • Tallinn, Estonia
    • Medicum Perearstikeskus AS
  • Tallinn, Estonia
    • Meie Tervis OU
  • Tallinn, Estonia
    • Merekivi Perearstid OU
  • Tallinn, Estonia
    • Merelahe Family Doctors Centre
  • Tallinn, Estonia
    • Mustamae Health Centre
  • Tartu, Estonia
    • Dr Monika Vask Ltd.
  • Voru, Estonia
    • Marje Toom Family Doctors Practice
• France
  • Vihiers, France
    • Cabinet Medical
  • Ille Et Vilaine
    • La Bouexiere, Ille Et Vilaine, France
      • Cabinet Medical
  • Indre Et Loire
    • Tours, Indre Et Loire, France
      • Cabinet Medical
  • Loire Atlantique
    • La Montagne, Loire Atlantique, France
      • Cabinet Medical
    • Nantes, Loire Atlantique, France
      • Cabinet Medical - Alain Boye
  • Maine Et Loire
    • Briollay, Maine Et Loire, France
      • Cabinet Medical
    • Murs-Erigne, Maine Et Loire, France
      • Cabinet Medical Jacques Marty
    • Segre, Maine Et Loire, France
      • Cabinet Medical Jean Charcot
• Germany
  • Hamburg, Germany
    • Praxis Dr. Schiewe
  • Baden Wuerttemberg
    • Freiburg, Baden Wuerttemberg, Germany
      • Institut fuer Praeventive Medizin Freiburg
  • Hessen
    • Dietzenbach, Hessen, Germany
      • Gemeinschaftspraxis Dr. Med. Reinhold Jerwan-Keim, Renate Metz
  • Nordrhein Westfalen
    • Essen, Nordrhein Westfalen, Germany
      • Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff
    • Essen, Nordrhein Westfalen, Germany
      • Hausarztzentrum Bocholder Strasse
    • Essen, Nordrhein Westfalen, Germany
      • Medizentrum Essen Borbeck
    • Essen, Nordrhein Westfalen, Germany
      • Unterfrintroper Hausarztzentrum
    • Goch, Nordrhein Westfalen, Germany
      • medicoKIT
    • Kamp-Lintfort, Nordrhein Westfalen, Germany
      • Gemeinschaftspraxis Heisters und Sungen
    • Koein, Nordrhein Westfalen, Germany
      • Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen
  • Sachsen
    • Dresden, Sachsen, Germany
      • ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH
• Hungary
  • Budapest, Hungary
    • Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
  • Budapest, Hungary
    • CSALADGYOGYYASZ Szolgaltato es Oktato Bt.
  • Budapest, Hungary
    • Haziorvosi Rendelo
  • Budapest, Hungary
    • QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft
  • Debrecen, Hungary
    • Kenezy Korhaz es Rendelointezet
  • Gyula, Hungary
    • Békés Megyei Pándy Kálmán Kórház
  • Kecskemet, Hungary
    • Felnott Haziorvosi Rendelo
  • Kecskemet, Hungary
    • Haziorvosi Rendelo
  • Miskolc, Hungary
    • Felnott Haziorvosi Rendelo
  • Nyiregyhaza, Hungary
    • Revamed Kft.
  • Szekesfehervar, Hungary
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Latvia
  • Balvi, Latvia
    • Liga Kozlovska family doctor practice
  • Jelgava, Latvia
    • Jelgava Outpatient Clinic
  • Kuldiga, Latvia
    • Dr. R. Eglite's Private Practice
  • Lielvarde, Latvia
    • Dr. Dz.Trosk's practice
  • Liepaja, Latvia
    • Regional Hospital of Liepaja
  • Rezekne, Latvia
    • Hospital of Reseknes
  • Riga, Latvia
    • Clinic of GP A.Lasmanis "ALMA"
  • Riga, Latvia
    • Vecverdina Vizma - GP Practice
• Mexico
  • Durango, Mexico
    • Nucleo Victoria de Investigacion Clinica S.C.
  • Oaxaca, Mexico
    • Oaxaca Site Management Organization S.C.
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico
      • Centro de Investigación Clinica Acelerada, S.C.
    • Mexico, Distrito Federal, Mexico
      • Centro de Investigacion Clínica GRAMEL S.C
    • Mexico, Distrito Federal, Mexico
      • Facultad Mexicana de Medicina, Universidad La Salle A.C.
    • Mexico, Distrito Federal, Mexico
      • Hospital Angeles Lindavista
    • Mexico, Distrito Federal, Mexico
      • Mexico Centre for Clinical Research S.A. de C.V
  • Estado De Mexico
    • Cuautitlan Izcalli, Estado De Mexico, Mexico
      • Phylasis Clinicas Research S de RL de CV
    • Tlalnepantla, Estado De Mexico, Mexico
      • Clinical Research Institute S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)
    • Zapopan, Jalisco, Mexico
      • Hospital de Especialidades Centro Medico Puerta de Hierro
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico
      • Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey
    • Monterrey, Nuevo Leon, Mexico
      • Hospital Universitario de Monterrey
• New Zealand
  • Auckland, New Zealand
    • Optimal Clinical Trials
  • Christchurch, New Zealand
    • Primorus Clinical Trials Ltd
  • Christchurch, New Zealand
    • Shirley Medical Centre
  • Hamilton, New Zealand
    • Clinical Trials New Zealand Ltd
  • Remuera, New Zealand
    • Auckland Family Medical Centre
• Peru
  • Arequipa, Peru
    • Hospital Nacional Carlos Alberto Seguin Escobedo
  • Cusco, Peru
    • Hospital Nacional Adolfo Guevara Velasco
  • Lima, Peru
    • Clinica Internacional Sede San Borja
  • Lima, Peru
    • Hospital Nacional Arzobispo Loayza
  • Lima, Peru
    • Clinica San Borja
  • Lima, Peru
    • Hospital Maria Auxiliadora
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa
      • Global Clinical Trials PE
  • Free State
    • Bloemfontein, Free State, South Africa
      • Iatros International
    • Bloemfontein, Free State, South Africa
      • Josha Research
    • Welkom, Free State, South Africa
      • Drs YAK Vahed and Partners
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Maphutha, MB
    • Johannesburg, Gauteng, South Africa
      • Medicross Roodepoort Clinical Research
    • Kempton Park, Gauteng, South Africa
      • Clinresco Centres (Pty) Ltd
    • Krugersdorp, Gauteng, South Africa
      • DJW Research
    • Mamelodi East, Gauteng, South Africa
      • Synexus SA, Stanza Bopape Clinical Research Centre
    • Pretoria, Gauteng, South Africa
      • Emmed Research
    • Pretoria, Gauteng, South Africa
      • Engelbrecht, I
    • Pretoria, Gauteng, South Africa
      • Global Clinical Trials Pretoria
    • Pretoria, Gauteng, South Africa
      • Jongaie Research
    • Pretoria, Gauteng, South Africa
      • Synexus SA - Watermeyer Clinical Research Centre
    • Pretoria, Gauteng, South Africa
      • Syzygy Clinical Research Services Wilgers
    • Pretoria, Gauteng, South Africa
      • University of Pretoria Clinical Research Unit
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa
      • De Villiers Clinical Trials
    • Durban, KwaZulu-Natal, South Africa
      • Sebastian, Peter
    • Durban, KwaZulu-Natal, South Africa
      • Synapta Clinical Research
    • Durban, KwaZulu-Natal, South Africa
      • van Rensburg, CJJ
    • Durban, KwaZulu-Natal, South Africa
      • Vawda, ZFA
    • Phoenix, KwaZulu-Natal, South Africa
      • Brookdale Clinical Research Centre
    • Richards Bay, KwaZulu-Natal, South Africa
      • Richards Bay Trial Centre (Pty) Ltd
    • Umkomaas, KwaZulu-Natal, South Africa
      • Aliwal Shoal Medical Centre
  • Limpopo
    • Thabazimbi, Limpopo, South Africa
      • Limpopo Clinical Research Initiative
  • Mpumalanga
    • Middelburg, Mpumalanga, South Africa
      • Mzansi Ethical Research Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Tiervlei Trial Centre
    • Cape Town, Western Cape, South Africa
      • Africa International Research
    • Cape Town, Western Cape, South Africa
      • Allergy Diagnostic & Clinical Research Unit
    • Cape Town, Western Cape, South Africa
      • Boyd, WV
    • Cape Town, Western Cape, South Africa
      • Helderberg Clinical Trials Centre
    • Cape Town, Western Cape, South Africa
      • Langeberg Clinical Trials
    • Cape Town, Western Cape, South Africa
      • Western Cape Clinical Trials
    • George, Western Cape, South Africa
      • Excellentis Clinical Trial Consultants
    • Somerset West, Western Cape, South Africa
      • Somerset West Clinical Trial Unit
    • Worcester, Western Cape, South Africa
      • Clinical Projects Research SA (PTY) LTD
• United Kingdom
  • Cambridgeshire
    • Ely, Cambridgeshire, United Kingdom
      • Staploe Medical Centre
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom
      • Avondale Surgery Research
  • Devon
    • Plymouth, Devon, United Kingdom
      • Knowle House Surgery
  • Hertfordshire
    • Watford, Hertfordshire, United Kingdom
      • Sheepcot Medical Centre
  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom
      • CPS Ltd
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom
      • Holbrook Lane Surgery
  • Wiltshire
    • Bradford-on-Avon, Wiltshire, United Kingdom
      • Bradford on Avon Health Centre
• United States
  • Alabama
    • Scottsboro, Alabama, United States, 35768
      • Scottsboro Quick Care Clinic
  • Arizona
    • Camp Verde, Arizona, United States, 86322
      • Clinical Trial Connection
    • Chandler, Arizona, United States, 85224
      • Warner Family Practice
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
      • Clinical Research Connections, LLC
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
  • California
    • Chula Vista, California, United States, 91911
      • eStudySite
    • Huntington Beach, California, United States, 92647
      • Beach Physicians Medical Group, Inc.
    • La Mesa, California, United States, 91942
      • eStudySite
    • Long Beach, California, United States, 90813-3296
      • Novo Research, Inc.
    • Norwalk, California, United States, 90650
      • Lucita M. Cruz, MD, Inc
    • Oceanside, California, United States, 92056
      • eStudySite
    • Orange, California, United States, 92868
      • Clinical Trials of Orange County, Inc
    • San Diego, California, United States, 92103-6204
      • California Research Foundation
    • San Diego, California, United States, 92120
      • San Diego Sports Medicine & Family Health Center
    • Tustin, California, United States, 92780
      • Orange County Research Center, Inc
    • Upland, California, United States, 91786
      • SC Clinical Research, Inc.
  • Colorado
    • Northglenn, Colorado, United States, 80234
      • Complete Family Care
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Brcr Medical Center, Inc Dba Boca Raton Clinical Research
    • Boynton Beach, Florida, United States, 33437
      • Zasa Clinical Research, LLC
    • Chiefland, Florida, United States, 32626
      • Southeast Clinical Research, LLC
    • Coral Gables, Florida, United States, 33134
      • Sanitas Research
    • Jacksonville, Florida, United States, 32216
      • Southeast Clinical Research, LLC - Parent
    • Miami, Florida, United States, 33175
      • New Horizon Research Center, Inc
    • Miami, Florida, United States, 33174
      • Columbus Clinical Services, LLC
    • Miami Lakes, Florida, United States, 33014
      • Crystal Biomedical Research
    • Orlando, Florida, United States, 32806
      • DCT - FMC, LLC, d/b/a Discovery Clinical Trials
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
  • Georgia
    • Snellville, Georgia, United States, 30039
      • Dr. B. Abraham, PC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Women's Healthcare Associates P.A.
  • Kentucky
    • Madisonville, Kentucky, United States, 42431-1665
      • Baptist Health Clinical Studies
  • Louisiana
    • Mandeville, Louisiana, United States, 70471
      • Clinical Trials Management, LLC
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management, LLC
    • Metairie, Louisiana, United States, 70006
      • Medipharmics, LLC
    • Natchitoches, Louisiana, United States, 71457
      • KAMP Medical Research
  • Maine
    • Bangor, Maine, United States, 04401
      • Paul Shapero, MD
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Bethesda Allergy, Asthma & Research Center, LLC
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Neccr Imca, Llc
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical Center
  • Michigan
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research Center
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
  • Nebraska
    • Bellevue, Nebraska, United States, 68005
      • Pioneer Clinical Research, LLC
    • Bellevue, Nebraska, United States, 68123-4303
      • The Asthma & Allergy Center, P.C. master
    • Fremont, Nebraska, United States, 68025
      • Beacom Family Health Connection
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • eStudySite
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Sentral Clinical Research Services, LLC
    • Milford, Ohio, United States, 45150
      • Hometown Urgent Care & Occupational Health
    • Sylvania, Ohio, United States, 43560
      • ProMedica Health System, Inc
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine & Associates
    • Warminster, Pennsylvania, United States, 18974
      • Warminster Medical Associates, PC
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • AAPRI Clinical Research Institute
  • South Carolina
    • Simpsonville, South Carolina, United States, 29681
      • Hillcrest Clinical Research, LLC
  • Tennessee
    • Columbia, Tennessee, United States, 38401
      • Clinical Research Solutions, PC
    • Franklin, Tennessee, United States, 37067
      • HCCA Clinical Research Solutions
    • Franklin, Tennessee, United States, 37604
      • Clinical Research Solutions, PC
    • Jackson, Tennessee, United States, 38305
      • HCCA Clinical Research Solutions
    • Knoxville, Tennessee, United States, 37912
      • PMG Research of Knoxville
    • Nashville, Tennessee, United States, 37211
      • Clinical Research Solutions, PC
    • Smyrna, Tennessee, United States, 37167
      • Clinical Research Solutions, PC
  • Texas
    • Plano, Texas, United States, 75024
      • ACRC Trials
    • San Antonio, Texas, United States, 78218
      • Oakwell Clinical Research
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute, LLC
    • San Antonio, Texas, United States, 78221-1615
      • DBA Southwest Clinic
    • San Antonio, Texas, United States, 78258
      • DCT-Stone Oak, LLC dba Discovery Clinical Trials
  • Utah
    • Clinton, Utah, United States, 84015
      • WestSide Medical
    • Draper, Utah, United States, 84020
      • Focus Clinical Research
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research - FirstMed East
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Infectious Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

   1. 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
   2. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
   3. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)

4. 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:

   1. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
   2. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
   3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching Placebo	Drug: Placebo; Other Names: Lactose
Active Comparator: 40 mg Laninamivir Octanoate DPI; 40 mg Laninamivir Octanoate and matching placebo	Drug: Placebo; Other Names: Lactose; Drug: 40 mg Laninamivir Octanoate; Other Names: CS-8958
Active Comparator: 80 mg Laninamivir Octanoate DPI; 80 mg Laninamivir	Drug: 80 mg Laninamivir Octanoate; Other Names: CS-8958

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biota Scientific Management Pty Ltd
• Collaborators: Department of Health and Human Services
• Investigators: Study Director: John Lambert, PhD, Biota Scientific Management Pty Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimate): February 18, 2013

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Influenza Laninamivir Octanoate
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Zanamivir; Laninamivir
• Other Study ID Numbers: BTA51-350-201; HHSO100201100019C (Other Grant/Funding Number: HHS BARDA); 2013-000582-36 (EudraCT Number)