Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
Launched by BIOTA SCIENTIFIC MANAGEMENT PTY LTD · Feb 14, 2013
Trial Information
Current as of May 24, 2025
Completed
Keywords
ClinConnect Summary
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 ho...
Gender
ALL
Eligibility criteria
- 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
About Biota Scientific Management Pty Ltd
Biota Scientific Management Pty Ltd is a leading clinical trial sponsor specializing in the development and management of innovative therapeutic solutions. With a commitment to advancing healthcare, the company focuses on conducting high-quality clinical research across various therapeutic areas. Leveraging a team of experienced professionals and a robust network of clinical sites, Biota Scientific Management ensures rigorous adherence to regulatory standards, ethical practices, and scientific integrity. Through strategic partnerships and a patient-centric approach, the organization aims to accelerate the delivery of groundbreaking treatments to improve patient outcomes and enhance the quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Worcester, Massachusetts, United States
Berlin, New Jersey, United States
Wentworthville, New South Wales, Australia
Port Orange, Florida, United States
Cairns, Queensland, Australia
Metairie, Louisiana, United States
Olive Branch, Mississippi, United States
Simpsonville, South Carolina, United States
Scottsboro, Alabama, United States
San Diego, California, United States
Troy, Michigan, United States
Hickory, North Carolina, United States
Jonesboro, Arkansas, United States
Mandeville, Louisiana, United States
San Antonio, Texas, United States
Arequipa, , Peru
Chiefland, Florida, United States
Warminster, Pennsylvania, United States
Newmarket, Ontario, Canada
Tallinn, , Estonia
Voru, , Estonia
Lima, , Peru
San Diego, California, United States
Chula Vista, California, United States
Oceanside, California, United States
Northglenn, Colorado, United States
Lima, , Peru
Clinton, Utah, United States
Roanoke, Virginia, United States
Las Vegas, Nevada, United States
Knoxville, Tennessee, United States
Coral Gables, Florida, United States
Jackson, Tennessee, United States
La Mesa, California, United States
Bellevue, Nebraska, United States
Miami, Florida, United States
Plano, Texas, United States
Lima, , Peru
Draper, Utah, United States
Chandler, Arizona, United States
Cincinnati, Ohio, United States
Camp Verde, Arizona, United States
Harrisburg, Arkansas, United States
Huntington Beach, California, United States
Long Beach, California, United States
Norwalk, California, United States
Orange, California, United States
Tustin, California, United States
Upland, California, United States
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Snellville, Georgia, United States
Idaho Falls, Idaho, United States
Madisonville, Kentucky, United States
Metairie, Louisiana, United States
Natchitoches, Louisiana, United States
Bangor, Maine, United States
Bethesda, Maryland, United States
Fall River, Massachusetts, United States
Bellevue, Nebraska, United States
Fremont, Nebraska, United States
Milford, Ohio, United States
Sylvania, Ohio, United States
Tulsa, Oklahoma, United States
Lansdale, Pennsylvania, United States
Warwick, Rhode Island, United States
Columbia, Tennessee, United States
Franklin, Tennessee, United States
Franklin, Tennessee, United States
Nashville, Tennessee, United States
Smyrna, Tennessee, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burwood, New South Wales, Australia
Sydney, New South Wales, Australia
Jimboomba, Queensland, Australia
Mermaid Beach, Queensland, Australia
Morayfield, Queensland, Australia
Sherwood, Queensland, Australia
Adelaide, South Australia, Australia
Broadmeadows, Victoria, Australia
Borgerhout, , Belgium
Halen, , Belgium
Herbeumont, , Belgium
Moerkerke, , Belgium
Moorsel, , Belgium
Mouscron, , Belgium
Oostham, , Belgium
Oudenaarde, , Belgium
Wetteren, , Belgium
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Veliko Tarnovo, , Bulgaria
Brampton, Ontario, Canada
Etobicoke, Ontario, Canada
Mirabel, Quebec, Canada
Quebec, , Canada
Bogota, , Colombia
Bogota, , Colombia
Bogota, , Colombia
Paide, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
La Bouexiere, Ille Et Vilaine, France
Tours, Indre Et Loire, France
La Montagne, Loire Atlantique, France
Nantes, Loire Atlantique, France
Briollay, Maine Et Loire, France
Murs Erigne, Maine Et Loire, France
Segre, Maine Et Loire, France
Vihiers, , France
Freiburg, Baden Wuerttemberg, Germany
Dietzenbach, Hessen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Goch, Nordrhein Westfalen, Germany
Kamp Lintfort, Nordrhein Westfalen, Germany
Koein, Nordrhein Westfalen, Germany
Dresden, Sachsen, Germany
Hamburg, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Kecskemet, , Hungary
Kecskemet, , Hungary
Miskolc, , Hungary
Nyiregyhaza, , Hungary
Szekesfehervar, , Hungary
Balvi, , Latvia
Jelgava, , Latvia
Kuldiga, , Latvia
Lielvarde, , Latvia
Liepaja, , Latvia
Rezekne, , Latvia
Riga, , Latvia
Riga, , Latvia
Mexico, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Cuautitlan Izcalli, Estado De Mexico, Mexico
Tlalnepantla, Estado De Mexico, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Monterrey, Nuevo Leon, Mexico
Durango, , Mexico
Oaxaca, , Mexico
Auckland, , New Zealand
Christchurch, , New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Remuera, , New Zealand
Cusco, , Peru
Lima, , Peru
Port Elizabeth, Eastern Cape, South Africa
Bloemfontein, Free State, South Africa
Bloemfontein, Free State, South Africa
Welkom, Free State, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Kempton Park, Gauteng, South Africa
Krugersdorp, Gauteng, South Africa
Mamelodi East, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, Kwazulu Natal, South Africa
Durban, Kwazulu Natal, South Africa
Durban, Kwazulu Natal, South Africa
Durban, Kwazulu Natal, South Africa
Durban, Kwazulu Natal, South Africa
Phoenix, Kwazulu Natal, South Africa
Richards Bay, Kwazulu Natal, South Africa
Umkomaas, Kwazulu Natal, South Africa
Thabazimbi, Limpopo, South Africa
Middelburg, Mpumalanga, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
George, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Ely, Cambridgeshire, United Kingdom
Chesterfield, Derbyshire, United Kingdom
Plymouth, Devon, United Kingdom
Watford, Hertfordshire, United Kingdom
Glasgow, Strathclyde, United Kingdom
Coventry, Warwickshire, United Kingdom
Bradford On Avon, Wiltshire, United Kingdom
Patients applied
Trial Officials
John Lambert, PhD
Study Director
Biota Scientific Management Pty Ltd
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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