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
3 other identifiers
interventional
639
16 countries
221
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
Shorter than P25 for phase_2
221 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2013
CompletedFirst Posted
Study publicly available on registry
February 18, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
September 1, 2017
CompletedMay 31, 2018
May 1, 2018
1 year
February 13, 2013
July 31, 2017
May 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
40 mg Laninamivir Octanoate DPI
ACTIVE COMPARATOR40 mg Laninamivir Octanoate and matching placebo
80 mg Laninamivir Octanoate DPI
ACTIVE COMPARATOR80 mg Laninamivir
Placebo
PLACEBO COMPARATORMatching Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (221)
Scottsboro Quick Care Clinic
Scottsboro, Alabama, 35768, United States
Clinical Trial Connection
Camp Verde, Arizona, 86322, United States
Warner Family Practice
Chandler, Arizona, 85224, United States
Clinical Research Connections, LLC
Harrisburg, Arkansas, 72432, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
eStudySite
Chula Vista, California, 91911, United States
Beach Physicians Medical Group, Inc.
Huntington Beach, California, 92647, United States
eStudySite
La Mesa, California, 91942, United States
Novo Research, Inc.
Long Beach, California, 90813-3296, United States
Lucita M. Cruz, MD, Inc
Norwalk, California, 90650, United States
eStudySite
Oceanside, California, 92056, United States
Clinical Trials of Orange County, Inc
Orange, California, 92868, United States
California Research Foundation
San Diego, California, 92103-6204, United States
San Diego Sports Medicine & Family Health Center
San Diego, California, 92120, United States
Orange County Research Center, Inc
Tustin, California, 92780, United States
SC Clinical Research, Inc.
Upland, California, 91786, United States
Complete Family Care
Northglenn, Colorado, 80234, United States
BRCR Medical Center, Inc DBA Boca Raton Clinical Research
Boca Raton, Florida, 33432, United States
Zasa Clinical Research, LLC
Boynton Beach, Florida, 33437, United States
Southeast Clinical Research, LLC
Chiefland, Florida, 32626, United States
Sanitas Research
Coral Gables, Florida, 33134, United States
Southeast Clinical Research, LLC - Parent
Jacksonville, Florida, 32216, United States
Columbus Clinical Services, LLC
Miami, Florida, 33174, United States
New Horizon Research Center, Inc
Miami, Florida, 33175, United States
Crystal Biomedical Research
Miami Lakes, Florida, 33014, United States
DCT - FMC, LLC, d/b/a Discovery Clinical Trials
Orlando, Florida, 32806, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Dr. B. Abraham, PC
Snellville, Georgia, 30039, United States
Women's Healthcare Associates P.A.
Idaho Falls, Idaho, 83404, United States
Baptist Health Clinical Studies
Madisonville, Kentucky, 42431-1665, United States
Clinical Trials Management, LLC
Mandeville, Louisiana, 70471, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Medipharmics, LLC
Metairie, Louisiana, 70006, United States
KAMP Medical Research
Natchitoches, Louisiana, 71457, United States
Paul Shapero, MD
Bangor, Maine, 04401, United States
Bethesda Allergy, Asthma & Research Center, LLC
Bethesda, Maryland, 20814, United States
Neccr Imca, Llc
Fall River, Massachusetts, 02720, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
Oakland Medical Research Center
Troy, Michigan, 48085, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005, United States
The Asthma & Allergy Center, P.C. master
Bellevue, Nebraska, 68123-4303, United States
Beacom Family Health Connection
Fremont, Nebraska, 68025, United States
eStudySite
Las Vegas, Nevada, 89109, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28602, United States
Sentral Clinical Research Services, LLC
Cincinnati, Ohio, 45236, United States
Hometown Urgent Care & Occupational Health
Milford, Ohio, 45150, United States
ProMedica Health System, Inc
Sylvania, Ohio, 43560, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Detweiler Family Medicine & Associates
Lansdale, Pennsylvania, 19446, United States
Warminster Medical Associates, PC
Warminster, Pennsylvania, 18974, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island, 02886, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681, United States
Clinical Research Solutions, PC
Columbia, Tennessee, 38401, United States
HCCA Clinical Research Solutions
Franklin, Tennessee, 37067, United States
Clinical Research Solutions, PC
Franklin, Tennessee, 37604, United States
HCCA Clinical Research Solutions
Jackson, Tennessee, 38305, United States
PMG Research of Knoxville
Knoxville, Tennessee, 37912, United States
Clinical Research Solutions, PC
Nashville, Tennessee, 37211, United States
Clinical Research Solutions, PC
Smyrna, Tennessee, 37167, United States
ACRC Trials
Plano, Texas, 75024, United States
Sun Research Institute, LLC
San Antonio, Texas, 78215, United States
Oakwell Clinical Research
San Antonio, Texas, 78218, United States
DBA Southwest Clinic
San Antonio, Texas, 78221-1615, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Westside Medical
Clinton, Utah, 84015, United States
Focus Clinical Research
Draper, Utah, 84020, United States
J. Lewis Research - FirstMed East
Salt Lake City, Utah, 84121, United States
Carilion Infectious Disease
Roanoke, Virginia, 24014, United States
Dr Doong's Surgery
Burwood, New South Wales, Australia
Hyde Park Medical
Sydney, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
Cairns Base Hospital
Cairns, Queensland, Australia
Jimboomba Junction Family Practice & Skin Cancer Clinic
Jimboomba, Queensland, Australia
Mermaid Beach Medical Centre
Mermaid Beach, Queensland, Australia
Morayfield 7 Day Medical Centre
Morayfield, Queensland, Australia
AusTrials Pty Ltd. Sherwood
Sherwood, Queensland, Australia
Pain & Anaesthesia Research Clinic
Adelaide, South Australia, Australia
Hunter Clinical Research
Broadmeadows, Victoria, Australia
Dokter Luc Timmermans
Borgerhout, Belgium
Vereecken Guy
Halen, Belgium
Calozet, Yven
Herbeumont, Belgium
Hutsebaut, Andre
Moerkerke, Belgium
Van Mulders, Norbert
Moorsel, Belgium
Parque, Jean-Luc
Mouscron, Belgium
Mortelmans, Jaak
Oostham, Belgium
Private Practice
Oudenaarde, Belgium
BVBA Dr. Luc Capiau
Wetteren, Belgium
SHATPPD-Ruse EOOD
Rousse, 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"
Sofia, Bulgaria
MDHAT Dr Stefan Cherkezov, AD
Veliko Tarnovo, Bulgaria
Aggarwal and Associates Ltd
Brampton, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Etobicoke, Ontario, Canada
SKDS Research Inc.
Newmarket, Ontario, Canada
Omnispec Clinical Research Inc
Mirabel, Quebec, Canada
Clinique Medicale St-Louis (Recherche) Inc
Québec, Canada
Administradora Country S.A.
Bogotá, Colombia
Centro de Investigacion Clinica - CAFAM
Bogotá, Colombia
Clinica Colsanitas S.A. sede Clinica Universitaria Columbia
Bogotá, Colombia
Vee Family Doctor's Center OY
Paide, 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
Tallinn, Estonia
Pirita Family Doctors Centre
Tallinn, Estonia
Dr Monika Vask Ltd.
Tartu, Estonia
Marje Toom Family Doctors Practice
Võru, Estonia
Cabinet Medical
La Bouëxière, Ille Et Vilaine, France
Cabinet Medical
Tours, Indre Et Loire, France
Cabinet Medical
La Montagne, Loire Atlantique, France
Cabinet Medical - Alain Boye
Nantes, Loire Atlantique, France
Cabinet Medical
Briollay, Maine Et Loire, France
Cabinet Medical Jacques Marty
Mûrs-Erigné, Maine Et Loire, France
Cabinet Medical Jean Charcot
Segré, Maine Et Loire, France
Cabinet Medical
Vihiers, France
Institut fuer Praeventive Medizin Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz
Dietzenbach, Hesse, Germany
Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff
Essen, North Rhine-Westphalia, Germany
Hausarztzentrum Bocholder Strasse
Essen, North Rhine-Westphalia, Germany
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, Germany
Unterfrintroper Hausarztzentrum
Essen, North Rhine-Westphalia, Germany
medicoKIT
Goch, North Rhine-Westphalia, Germany
Gemeinschaftspraxis Heisters und Sungen
Kamp-Lintfort, North Rhine-Westphalia, Germany
Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen
Koein, North Rhine-Westphalia, Germany
ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH
Dresden, Saxony, Germany
Praxis Dr. Schiewe
Hamburg, Germany
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
Budapest, Hungary
Kenezy Korhaz es Rendelointezet
Debrecen, Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, Hungary
Felnott Haziorvosi Rendelo
Kecskemét, Hungary
Haziorvosi Rendelo
Kecskemét, Hungary
Felnott Haziorvosi Rendelo
Miskolc, Hungary
Revamed Kft.
Nyíregyháza, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary
Liga Kozlovska Family Doctor Practice
Balvi, Latvia
Jelgava Outpatient Clinic
Jelgava, Latvia
Dr. R. Eglite's Private Practice
Kuldīga, Latvia
Dr. Dz.Trosk's practice
Lielvārde, Latvia
Regional Hospital of Liepaja
Liepāja, Latvia
Hospital of Reseknes
Rēzekne, Latvia
Clinic of GP A.Lasmanis "ALMA"
Riga, Latvia
Vecverdina Vizma - GP Practice
Riga, Latvia
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 Acelerada, S.C.
Mexico City, Mexico City, Mexico
Centro de Investigacion Clinica GRAMEL S.C
Mexico City, Mexico City, Mexico
Facultad Mexicana de Medicina, Universidad La Salle A.C.
Mexico City, Mexico City, Mexico
Hospital Angeles Lindavista
Mexico City, Mexico City, Mexico
Mexico Centre for Clinical Research S.A. de C.V
Mexico City, Mexico City, Mexico
Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey
Monterrey, Nuevo León, Mexico
Hospital Universitario de Monterrey
Monterrey, Nuevo León, Mexico
Phylasis Clinicas Research S de RL de CV
Cuautitlán Izcalli, State of Mexico, Mexico
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, Mexico
Nucleo Victoria de Investigacion Clinica S.C.
Durango, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, Mexico
Optimal Clinical Trials
Auckland, New Zealand
Primorus Clinical Trials Ltd
Christchurch, New Zealand
Shirley Medical Centre
Christchurch, New Zealand
Clinical Trials New Zealand Ltd
Hamilton, New Zealand
Auckland Family Medical Centre
Remuera, New Zealand
Hospital Nacional Carlos Alberto Seguin Escobedo
Arequipa, Peru
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru
Clinica Internacional Sede San Borja
Lima, Peru
Clinica San Borja
Lima, Peru
Hospital Maria Auxiliadora
Lima, Peru
Hospital Nacional Arzobispo Loayza
Lima, Peru
Global Clinical Trials PE
Port Elizabeth, Eastern Cape, South Africa
Iatros International
Bloemfontein, Free State, South Africa
Josha Research
Bloemfontein, Free State, South Africa
Drs YAK Vahed and Partners
Welkom, Free State, South Africa
Maphutha, MB
Johannesburg, Gauteng, South Africa
Medicross Roodepoort Clinical Research
Johannesburg, Gauteng, South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, South Africa
DJW Research
Krugersdorp, Gauteng, South Africa
Synexus SA, Stanza Bopape Clinical Research Centre
Mamelodi East, 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
Pretoria, Gauteng, 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
Durban, KwaZulu-Natal, South Africa
Aliwal Shoal Medical Centre
eMkhomazi, KwaZulu-Natal, South Africa
Brookdale Clinical Research Centre
Phoenix, KwaZulu-Natal, South Africa
Richards Bay Trial Centre (Pty) Ltd
Richards Bay, KwaZulu-Natal, South Africa
Limpopo Clinical Research Initiative
Thabazimbi, Limpopo, South Africa
Mzansi Ethical Research Centre
Middelburg, Mpumalanga, 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
Tiervlei Trial Centre
Cape Town, Western Cape, South Africa
Western Cape Clinical Trials
Cape Town, Western Cape, South Africa
Excellentis Clinical Trial Consultants
George, Western Cape, South Africa
Somerset West Clinical Trial Unit
Somerset West, Western Cape, South Africa
Clinical Projects Research SA (PTY) LTD
Worcester, Western Cape, South Africa
Staploe Medical Centre
Ely, Cambridgeshire, United Kingdom
Avondale Surgery Research
Chesterfield, Derbyshire, United Kingdom
Knowle House Surgery
Plymouth, Devon, United Kingdom
Sheepcot Medical Centre
Watford, Hertfordshire, United Kingdom
CPS Ltd
Glasgow, Strathclyde, United Kingdom
Holbrook Lane Surgery
Coventry, Warwickshire, United Kingdom
Bradford on Avon Health Centre
Bradford-on-Avon, Wiltshire, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Novotney-Barry
- Organization
- Aviragen Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
John Lambert, PhD
Biota Scientific Management Pty Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2013
First Posted
February 18, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 31, 2018
Results First Posted
September 1, 2017
Record last verified: 2018-05