Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
- Conditions
- Influenza
- Interventions
- Registration Number
- NCT01793883
- Lead Sponsor
- Biota Scientific Management Pty Ltd
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 639
-
Provide written informed consent
-
Males or females aged 18-64 years, inclusive
-
Symptomatic presumptive influenza A or B infection defined as the presence of:
- 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
- ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
- ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)
-
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:
- time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
- time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
- time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)
Main
- Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
- Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks.
- History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma
- 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
- Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
- Presence of clinically significant signs of acute respiratory distress during screening
- Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 40 mg Laninamivir Octanoate DPI 40 mg Laninamivir Octanoate 40 mg Laninamivir Octanoate and matching placebo 40 mg Laninamivir Octanoate DPI Placebo 40 mg Laninamivir Octanoate and matching placebo 80 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate 80 mg Laninamivir Placebo Placebo Matching Placebo
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (207)
Clinical Research Solutions, PC
🇺🇸Smyrna, Tennessee, United States
BRCR Medical Center, Inc DBA Boca Raton Clinical Research
🇺🇸Boca Raton, Florida, United States
Clinical Research Connections, LLC
🇺🇸Harrisburg, Arkansas, United States
Southeast Clinical Research, LLC
🇺🇸Chiefland, Florida, United States
Clinical Trials of Orange County, Inc
🇺🇸Orange, California, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
SC Clinical Research, Inc.
🇺🇸Upland, California, United States
Advanced Medical Research Center
🇺🇸Port Orange, Florida, United States
Baptist Health Clinical Studies
🇺🇸Madisonville, Kentucky, United States
Paul Shapero, MD
🇺🇸Bangor, Maine, United States
Warminster Medical Associates, PC
🇺🇸Warminster, Pennsylvania, United States
Pioneer Clinical Research, LLC
🇺🇸Bellevue, Nebraska, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
Hometown Urgent Care & Occupational Health
🇺🇸Milford, Ohio, United States
Neccr Imca, Llc
🇺🇸Fall River, Massachusetts, United States
Novo Research, Inc.
🇺🇸Long Beach, California, United States
University of Massachusetts Medical Center
🇺🇸Worcester, Massachusetts, United States
Orange County Research Center, Inc
🇺🇸Tustin, California, United States
KAMP Medical Research
🇺🇸Natchitoches, Louisiana, United States
Beacom Family Health Connection
🇺🇸Fremont, Nebraska, United States
Crystal Biomedical Research
🇺🇸Miami Lakes, Florida, United States
Hillcrest Clinical Research, LLC
🇺🇸Simpsonville, South Carolina, United States
Hutsebaut, Andre
🇧🇪Moerkerke, Belgium
Hyde Park Medical
🇦🇺Sydney, New South Wales, Australia
Fifth MHAT-Sofia, EAD
🇧🇬Sofia, Bulgaria
ACRC Trials
🇺🇸Plano, Texas, United States
Medipharmics, LLC
🇺🇸Metairie, Louisiana, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Cairns Base Hospital
🇦🇺Cairns, Queensland, Australia
Cabinet Medical Jean Charcot
🇫🇷Segre, Maine Et Loire, France
Dokter Luc Timmermans
🇧🇪Borgerhout, Belgium
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Detweiler Family Medicine & Associates
🇺🇸Lansdale, Pennsylvania, United States
UMHAT " Alexandrovska" EAD
🇧🇬Sofia, Bulgaria
Military Medical Academy - MHAT - Sofia
🇧🇬Sofia, Bulgaria
Women's Healthcare Associates P.A.
🇺🇸Idaho Falls, Idaho, United States
Calozet, Yven
🇧🇪Herbeumont, Belgium
Mortelmans, Jaak
🇧🇪Oostham, Belgium
Private Practice
🇧🇪Oudenaarde, Belgium
Carilion Infectious Disease
🇺🇸Roanoke, Virginia, United States
Jimboomba Junction Family Practice & Skin Cancer Clinic
🇦🇺Jimboomba, Queensland, Australia
SHATPPD-Ruse EOOD
🇧🇬Ruse, Bulgaria
Aggarwal and Associates Ltd
🇨🇦Brampton, Ontario, Canada
Diagnostic Consultative Center II - Sofia OOD
🇧🇬Sofia, Bulgaria
BVBA Dr. Luc Capiau
🇧🇪Wetteren, Belgium
Clinique Medicale St-Louis (Recherche) Inc
🇨🇦Quebec, Canada
Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz
🇩🇪Dietzenbach, Hessen, Germany
Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
🇭🇺Budapest, Hungary
MDHAT Dr Stefan Cherkezov, AD
🇧🇬Veliko Tarnovo, Bulgaria
DCARC "Hill Clinic"
🇧🇬Sofia, Bulgaria
MHAT "Lyulin", EAD
🇧🇬Sofia, Bulgaria
Vereecken Guy
🇧🇪Halen, Belgium
Parque, Jean-Luc
🇧🇪Mouscron, Belgium
Medizentrum Essen Borbeck
🇩🇪Essen, Nordrhein Westfalen, Germany
Felnott Haziorvosi Rendelo
🇭🇺Miskolc, Hungary
UMHAT 'Lozenets"
🇧🇬Sofia, Bulgaria
Cabinet Medical
🇫🇷Vihiers, France
NMTH "Tsar Boris III"
🇧🇬Sofia, Bulgaria
Mermaid Beach Medical Centre
🇦🇺Mermaid Beach, Queensland, Australia
Hunter Clinical Research
🇦🇺Broadmeadows, Victoria, Australia
Praxis Dr. Schiewe
🇩🇪Hamburg, Germany
Kenezy Korhaz es Rendelointezet
🇭🇺Debrecen, Hungary
Maphutha, MB
🇿🇦Johannesburg, Gauteng, South Africa
CSALADGYOGYYASZ Szolgaltato es Oktato Bt.
🇭🇺Budapest, Hungary
Bekes Megyei Pandy Kalman Korhaz
🇭🇺Gyula, Hungary
Cabinet Medical Jacques Marty
🇫🇷Murs-Erigne, Maine Et Loire, France
Optimal Clinical Trials
🇳🇿Auckland, New Zealand
Shirley Medical Centre
🇳🇿Christchurch, New Zealand
Clinresco Centres (Pty) Ltd
🇿🇦Kempton Park, Gauteng, South Africa
Medicross Roodepoort Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
Auckland Family Medical Centre
🇳🇿Remuera, New Zealand
Revamed Kft.
🇭🇺Nyiregyhaza, Hungary
QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft
🇭🇺Budapest, Hungary
Engelbrecht, I
🇿🇦Pretoria, Gauteng, South Africa
Haziorvosi Rendelo
🇭🇺Kecskemet, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Szekesfehervar, Hungary
Primorus Clinical Trials Ltd
🇳🇿Christchurch, New Zealand
Clinical Trials New Zealand Ltd
🇳🇿Hamilton, New Zealand
University of Pretoria Clinical Research Unit
🇿🇦Pretoria, Gauteng, South Africa
Syzygy Clinical Research Services Wilgers
🇿🇦Pretoria, Gauteng, South Africa
Emmed Research
🇿🇦Pretoria, Gauteng, South Africa
Jongaie Research
🇿🇦Pretoria, Gauteng, South Africa
Western Cape Clinical Trials
🇿🇦Cape Town, Western Cape, South Africa
Synexus SA - Watermeyer Clinical Research Centre
🇿🇦Pretoria, Gauteng, South Africa
Columbus Clinical Services, LLC
🇺🇸Miami, Florida, United States
New Horizon Research Center, Inc
🇺🇸Miami, Florida, United States
Bethesda Allergy, Asthma & Research Center, LLC
🇺🇸Bethesda, Maryland, United States
eStudySite
🇺🇸Las Vegas, Nevada, United States
California Research Foundation
🇺🇸San Diego, California, United States
San Diego Sports Medicine & Family Health Center
🇺🇸San Diego, California, United States
Sentral Clinical Research Services, LLC
🇺🇸Cincinnati, Ohio, United States
Sun Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Oakwell Clinical Research
🇺🇸San Antonio, Texas, United States
DBA Southwest Clinic
🇺🇸San Antonio, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Brookdale Clinical Research Centre
🇿🇦Phoenix, KwaZulu-Natal, South Africa
Synapta Clinical Research
🇿🇦Durban, KwaZulu-Natal, South Africa
van Rensburg, CJJ
🇿🇦Durban, KwaZulu-Natal, South Africa
De Villiers Clinical Trials
🇿🇦Durban, KwaZulu-Natal, South Africa
Aliwal Shoal Medical Centre
🇿🇦Umkomaas, KwaZulu-Natal, South Africa
Sebastian, Peter
🇿🇦Durban, KwaZulu-Natal, South Africa
Vawda, ZFA
🇿🇦Durban, KwaZulu-Natal, South Africa
Richards Bay Trial Centre (Pty) Ltd
🇿🇦Richards Bay, KwaZulu-Natal, South Africa
J. Lewis Research - FirstMed East
🇺🇸Salt Lake City, Utah, United States
HCCA Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Medicum Perearstikeskus AS
🇪🇪Tallinn, Estonia
Meie Tervis OU
🇪🇪Tallinn, Estonia
Mustamae Health Centre
🇪🇪Tallinn, Estonia
Pirita Family Doctors Centre
🇪🇪Tallinn, Estonia
Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)
🇲🇽Guadalajara, Jalisco, Mexico
Hospital de Especialidades Centro Medico Puerta de Hierro
🇲🇽Zapopan, Jalisco, Mexico
Centro de Investigacion Clinica - CAFAM
🇨🇴Bogota, Colombia
Vee Family Doctor's Center OY
🇪🇪Paide, Estonia
Merelahe Family Doctors Centre
🇪🇪Tallinn, Estonia
Dr Monika Vask Ltd.
🇪🇪Tartu, Estonia
Marje Toom Family Doctors Practice
🇪🇪Voru, Estonia
Liga Kozlovska Family Doctor Practice
🇱🇻Balvi, Latvia
Hospital of Reseknes
🇱🇻Rezekne, Latvia
Hospital Universitario de Monterrey
🇲🇽Monterrey, Nuevo Leon, Mexico
Clinica Internacional Sede San Borja
🇵🇪Lima, Peru
Josha Research
🇿🇦Bloemfontein, Free State, South Africa
Scottsboro Quick Care Clinic
🇺🇸Scottsboro, Alabama, United States
Warner Family Practice
🇺🇸Chandler, Arizona, United States
Clinical Trial Connection
🇺🇸Camp Verde, Arizona, United States
Beach Physicians Medical Group, Inc.
🇺🇸Huntington Beach, California, United States
Lucita M. Cruz, MD, Inc
🇺🇸Norwalk, California, United States
Sanitas Research
🇺🇸Coral Gables, Florida, United States
Southeast Clinical Research, LLC - Parent
🇺🇸Jacksonville, Florida, United States
Zasa Clinical Research, LLC
🇺🇸Boynton Beach, Florida, United States
Complete Family Care
🇺🇸Northglenn, Colorado, United States
The Asthma & Allergy Center, P.C. master
🇺🇸Bellevue, Nebraska, United States
DCT - FMC, LLC, d/b/a Discovery Clinical Trials
🇺🇸Orlando, Florida, United States
Dr. B. Abraham, PC
🇺🇸Snellville, Georgia, United States
Oakland Medical Research Center
🇺🇸Troy, Michigan, United States
ProMedica Health System, Inc
🇺🇸Sylvania, Ohio, United States
PMG Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
AAPRI Clinical Research Institute
🇺🇸Warwick, Rhode Island, United States
Westside Medical
🇺🇸Clinton, Utah, United States
Pain & Anaesthesia Research Clinic
🇦🇺Adelaide, South Australia, Australia
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
AusTrials Pty Ltd. Sherwood
🇦🇺Sherwood, Queensland, Australia
Van Mulders, Norbert
🇧🇪Moorsel, Belgium
Omnispec Clinical Research Inc
🇨🇦Mirabel, Quebec, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
🇨🇦Etobicoke, Ontario, Canada
Clinica Colsanitas S.A. sede Clinica Universitaria Columbia
🇨🇴Bogota, Colombia
Merekivi Perearstid OU
🇪🇪Tallinn, Estonia
Cabinet Medical - Alain Boye
🇫🇷Nantes, Loire Atlantique, France
Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff
🇩🇪Essen, Nordrhein Westfalen, Germany
Unterfrintroper Hausarztzentrum
🇩🇪Essen, Nordrhein Westfalen, Germany
Institut fuer Praeventive Medizin Freiburg
🇩🇪Freiburg, Baden Wuerttemberg, Germany
Hausarztzentrum Bocholder Strasse
🇩🇪Essen, Nordrhein Westfalen, Germany
Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen
🇩🇪Koein, Nordrhein Westfalen, Germany
ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH
🇩🇪Dresden, Sachsen, Germany
medicoKIT
🇩🇪Goch, Nordrhein Westfalen, Germany
Gemeinschaftspraxis Heisters und Sungen
🇩🇪Kamp-Lintfort, Nordrhein Westfalen, Germany
Dr. R. Eglite's Private Practice
🇱🇻Kuldiga, Latvia
Regional Hospital of Liepaja
🇱🇻Liepaja, Latvia
Jelgava Outpatient Clinic
🇱🇻Jelgava, Latvia
Facultad Mexicana de Medicina, Universidad La Salle A.C.
🇲🇽Mexico, Distrito Federal, Mexico
Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital Nacional Adolfo Guevara Velasco
🇵🇪Cusco, Peru
Drs YAK Vahed and Partners
🇿🇦Welkom, Free State, South Africa
DJW Research
🇿🇦Krugersdorp, Gauteng, South Africa
Synexus SA, Stanza Bopape Clinical Research Centre
🇿🇦Mamelodi East, Gauteng, South Africa
Global Clinical Trials Pretoria
🇿🇦Pretoria, Gauteng, South Africa
Mzansi Ethical Research Centre
🇿🇦Middelburg, Mpumalanga, South Africa
Boyd, WV
🇿🇦Cape Town, Western Cape, South Africa
Helderberg Clinical Trials Centre
🇿🇦Cape Town, Western Cape, South Africa
Tiervlei Trial Centre
🇿🇦Cape Town, Western Cape, South Africa
Clinical Projects Research SA (PTY) LTD
🇿🇦Worcester, Western Cape, South Africa
Avondale Surgery Research
🇬🇧Chesterfield, Derbyshire, United Kingdom
CPS Ltd
🇬🇧Glasgow, Strathclyde, United Kingdom
Knowle House Surgery
🇬🇧Plymouth, Devon, United Kingdom
Bradford on Avon Health Centre
🇬🇧Bradford-on-Avon, Wiltshire, United Kingdom
Sheepcot Medical Centre
🇬🇧Watford, Hertfordshire, United Kingdom
Holbrook Lane Surgery
🇬🇧Coventry, Warwickshire, United Kingdom
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
SKDS Research Inc.
🇨🇦Newmarket, Ontario, Canada
Allergy Diagnostic & Clinical Research Unit
🇿🇦Cape Town, Western Cape, South Africa
Hospital Angeles Lindavista
🇲🇽Mexico, Distrito Federal, Mexico
Clinical Research Institute S.C.
🇲🇽Tlalnepantla, Estado De Mexico, Mexico
Oaxaca Site Management Organization S.C.
🇲🇽Oaxaca, Mexico
Hospital Nacional Carlos Alberto Seguin Escobedo
🇵🇪Arequipa, Peru
Hospital Maria Auxiliadora
🇵🇪Lima, Peru
Langeberg Clinical Trials
🇿🇦Cape Town, Western Cape, South Africa
Administradora Country S.A.
🇨🇴Bogota, Colombia
Phylasis Clinicas Research S de RL de CV
🇲🇽Cuautitlan Izcalli, Estado De Mexico, Mexico
Staploe Medical Centre
🇬🇧Ely, Cambridgeshire, United Kingdom
Africa International Research
🇿🇦Cape Town, Western Cape, South Africa
Limpopo Clinical Research Initiative
🇿🇦Thabazimbi, Limpopo, South Africa
Dr. Dz.Trosk's practice
🇱🇻Lielvarde, Latvia
Centro de Investigacion Clinica Acelerada, S.C.
🇲🇽Mexico, Distrito Federal, Mexico
Centro de Investigacion Clinica GRAMEL S.C
🇲🇽Mexico, Distrito Federal, Mexico
Mexico Centre for Clinical Research S.A. de C.V
🇲🇽Mexico, Distrito Federal, Mexico
Nucleo Victoria de Investigacion Clinica S.C.
🇲🇽Durango, Mexico
Clinica San Borja
🇵🇪Lima, Peru
Hospital Nacional Arzobispo Loayza
🇵🇪Lima, Peru
Clinic of GP A.Lasmanis "ALMA"
🇱🇻Riga, Latvia
Vecverdina Vizma - GP Practice
🇱🇻Riga, Latvia
Somerset West Clinical Trial Unit
🇿🇦Somerset West, Western Cape, South Africa
Global Clinical Trials PE
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Excellentis Clinical Trial Consultants
🇿🇦George, Western Cape, South Africa
Iatros International
🇿🇦Bloemfontein, Free State, South Africa
Focus Clinical Research
🇺🇸Draper, Utah, United States
Dr Doong's Surgery
🇦🇺Burwood, New South Wales, Australia
Morayfield 7 Day Medical Centre
🇦🇺Morayfield, Queensland, Australia