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

Influenza Clinical Trial

— Igloo  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793883
• Other study ID #: BTA51-350-201
• Secondary ID: HHSO100201100019
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 639
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• 40 mg Laninamivir Octanoate

• 80 mg Laninamivir Octanoate

• Placebo

Locations

Country	Name	City	State
Australia	Pain & Anaesthesia Research Clinic	Adelaide	South Australia
Australia	Hunter Clinical Research	Broadmeadows	Victoria
Australia	Dr Doong's Surgery	Burwood	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	Hyde Park Medical	Sydney	New South Wales
Australia	Westmead Hospital	Wentworthville	New South Wales
Belgium	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
Bulgaria	SHATPPD-Ruse EOOD	Ruse
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
Canada	Aggarwal and Associates Ltd	Brampton	Ontario
Canada	Dr. Anil K. Gupta Medicine Professional Corporation	Etobicoke	Ontario
Canada	Omnispec Clinical Research Inc	Mirabel	Quebec
Canada	SKDS Research Inc.	Newmarket	Ontario
Canada	Clinique Medicale St-Louis (Recherche) Inc	Quebec
Colombia	Administradora Country S.A.	Bogota
Colombia	Centro de Investigacion Clinica - CAFAM	Bogota
Colombia	Clinica Colsanitas S.A. sede Clinica Universitaria Columbia	Bogota
Estonia	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	Voru
France	Cabinet Medical	Briollay	Maine Et Loire
France	Cabinet Medical	La Bouexiere	Ille Et Vilaine
France	Cabinet Medical	La Montagne	Loire Atlantique
France	Cabinet Medical Jacques Marty	Murs-Erigne	Maine Et Loire
France	Cabinet Medical - Alain Boye	Nantes	Loire Atlantique
France	Cabinet Medical Jean Charcot	Segre	Maine Et Loire
France	Cabinet Medical	Tours	Indre Et Loire
France	Cabinet Medical	Vihiers
Germany	Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz	Dietzenbach	Hessen
Germany	ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH	Dresden	Sachsen
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	Essen	Nordrhein Westfalen
Germany	Institut fuer Praeventive Medizin Freiburg	Freiburg	Baden Wuerttemberg
Germany	medicoKIT	Goch	Nordrhein Westfalen
Germany	Praxis Dr. Schiewe	Hamburg
Germany	Gemeinschaftspraxis Heisters und Sungen	Kamp-Lintfort	Nordrhein Westfalen
Germany	Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen	Koein	Nordrhein Westfalen
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	Budapest
Hungary	Kenezy Korhaz es Rendelointezet	Debrecen
Hungary	Bekes Megyei Pandy Kalman Korhaz	Gyula
Hungary	Felnott Haziorvosi Rendelo	Kecskemet
Hungary	Haziorvosi Rendelo	Kecskemet
Hungary	Felnott Haziorvosi Rendelo	Miskolc
Hungary	Revamed Kft.	Nyiregyhaza
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar
Latvia	Liga Kozlovska Family Doctor Practice	Balvi
Latvia	Jelgava Outpatient Clinic	Jelgava
Latvia	Dr. R. Eglite's Private Practice	Kuldiga
Latvia	Dr. Dz.Trosk's practice	Lielvarde
Latvia	Regional Hospital of Liepaja	Liepaja
Latvia	Hospital of Reseknes	Rezekne
Latvia	Clinic of GP A.Lasmanis "ALMA"	Riga
Latvia	Vecverdina Vizma - GP Practice	Riga
Mexico	Phylasis Clinicas Research S de RL de CV	Cuautitlan Izcalli	Estado De Mexico
Mexico	Nucleo Victoria de Investigacion Clinica S.C.	Durango
Mexico	Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)	Guadalajara	Jalisco
Mexico	Centro de Investigacion Clinica Acelerada, S.C.	Mexico	Distrito Federal
Mexico	Centro de Investigacion Clinica 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	Mexico	Distrito Federal
Mexico	Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey	Monterrey	Nuevo Leon
Mexico	Hospital Universitario de Monterrey	Monterrey	Nuevo Leon
Mexico	Oaxaca Site Management Organization S.C.	Oaxaca
Mexico	Clinical Research Institute S.C.	Tlalnepantla	Estado De Mexico
Mexico	Hospital de Especialidades Centro Medico Puerta de Hierro	Zapopan	Jalisco
New Zealand	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
Peru	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
South Africa	Iatros International	Bloemfontein	Free State
South Africa	Josha Research	Bloemfontein	Free State
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	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	Excellentis Clinical Trial Consultants	George	Western Cape
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	Mzansi Ethical Research Centre	Middelburg	Mpumalanga
South Africa	Brookdale Clinical Research Centre	Phoenix	KwaZulu-Natal
South Africa	Global Clinical Trials PE	Port Elizabeth	Eastern Cape
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	Richards Bay Trial Centre (Pty) Ltd	Richards Bay	KwaZulu-Natal
South Africa	Somerset West Clinical Trial Unit	Somerset West	Western Cape
South Africa	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo
South Africa	Aliwal Shoal Medical Centre	Umkomaas	KwaZulu-Natal
South Africa	Drs YAK Vahed and Partners	Welkom	Free State
South Africa	Clinical Projects Research SA (PTY) LTD	Worcester	Western Cape
United Kingdom	Bradford on Avon Health Centre	Bradford-on-Avon	Wiltshire
United Kingdom	Avondale Surgery Research	Chesterfield	Derbyshire
United Kingdom	Holbrook Lane Surgery	Coventry	Warwickshire
United Kingdom	Staploe Medical Centre	Ely	Cambridgeshire
United Kingdom	CPS Ltd	Glasgow	Strathclyde
United Kingdom	Knowle House Surgery	Plymouth	Devon
United Kingdom	Sheepcot Medical Centre	Watford	Hertfordshire
United States	Paul Shapero, MD	Bangor	Maine
United States	Pioneer Clinical Research, LLC	Bellevue	Nebraska
United States	The Asthma & Allergy Center, P.C. master	Bellevue	Nebraska
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Bethesda Allergy, Asthma & Research Center, LLC	Bethesda	Maryland
United States	BRCR Medical Center, Inc DBA Boca Raton Clinical Research	Boca Raton	Florida
United States	Zasa Clinical Research, LLC	Boynton Beach	Florida
United States	Clinical Trial Connection	Camp Verde	Arizona
United States	Warner Family Practice	Chandler	Arizona
United States	Southeast Clinical Research, LLC	Chiefland	Florida
United States	eStudySite	Chula Vista	California
United States	Sentral Clinical Research Services, LLC	Cincinnati	Ohio
United States	Westside Medical	Clinton	Utah
United States	Clinical Research Solutions, PC	Columbia	Tennessee
United States	Sanitas Research	Coral Gables	Florida
United States	Focus Clinical Research	Draper	Utah
United States	Neccr Imca, Llc	Fall River	Massachusetts
United States	Clinical Research Solutions, PC	Franklin	Tennessee
United States	HCCA Clinical Research Solutions	Franklin	Tennessee
United States	Beacom Family Health Connection	Fremont	Nebraska
United States	Clinical Research Connections, LLC	Harrisburg	Arkansas
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Beach Physicians Medical Group, Inc.	Huntington Beach	California
United States	Women's Healthcare Associates P.A.	Idaho Falls	Idaho
United States	HCCA Clinical Research Solutions	Jackson	Tennessee
United States	Southeast Clinical Research, LLC - Parent	Jacksonville	Florida
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	PMG Research of Knoxville	Knoxville	Tennessee
United States	eStudySite	La Mesa	California
United States	Detweiler Family Medicine & Associates	Lansdale	Pennsylvania
United States	eStudySite	Las Vegas	Nevada
United States	Novo Research, Inc.	Long Beach	California
United States	Baptist Health Clinical Studies	Madisonville	Kentucky
United States	Clinical Trials Management, LLC	Mandeville	Louisiana
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Medipharmics, LLC	Metairie	Louisiana
United States	Columbus Clinical Services, LLC	Miami	Florida
United States	New Horizon Research Center, Inc	Miami	Florida
United States	Crystal Biomedical Research	Miami Lakes	Florida
United States	Hometown Urgent Care & Occupational Health	Milford	Ohio
United States	Clinical Research Solutions, PC	Nashville	Tennessee
United States	KAMP Medical Research	Natchitoches	Louisiana
United States	Complete Family Care	Northglenn	Colorado
United States	Lucita M. Cruz, MD, Inc	Norwalk	California
United States	eStudySite	Oceanside	California
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Clinical Trials of Orange County, Inc	Orange	California
United States	DCT - FMC, LLC, d/b/a Discovery Clinical Trials	Orlando	Florida
United States	ACRC Trials	Plano	Texas
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Carilion Infectious Disease	Roanoke	Virginia
United States	J. Lewis Research - FirstMed East	Salt Lake City	Utah
United States	DBA Southwest Clinic	San Antonio	Texas
United States	DCT-Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	Oakwell Clinical Research	San Antonio	Texas
United States	Sun Research Institute, LLC	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	San Diego Sports Medicine & Family Health Center	San Diego	California
United States	Scottsboro Quick Care Clinic	Scottsboro	Alabama
United States	Hillcrest Clinical Research, LLC	Simpsonville	South Carolina
United States	Clinical Research Solutions, PC	Smyrna	Tennessee
United States	Dr. B. Abraham, PC	Snellville	Georgia
United States	ProMedica Health System, Inc	Sylvania	Ohio
United States	Oakland Medical Research Center	Troy	Michigan
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Orange County Research Center, Inc	Tustin	California
United States	SC Clinical Research, Inc.	Upland	California
United States	Warminster Medical Associates, PC	Warminster	Pennsylvania
United States	AAPRI Clinical Research Institute	Warwick	Rhode Island
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Biota Scientific Management Pty Ltd	Department of Health and Human Services

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Colombia,  Estonia,  France,  Germany,  Hungary,  Latvia,  Mexico,  New Zealand,  Peru,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.