InfluenzaPhase 1/2FROSTYNCT02014649
Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza
A Phase 1/2 study testing 20 mg laninamivir octanoate and 40 mg laninamivir octanoate in people with Influenza, run by Biota Scientific Management Pty Ltd at 28 sites in United States.
Trial summary
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Influenza
- What is being tested?
- 20 mg laninamivir octanoate and 40 mg laninamivir octanoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 28 sitesUnited States
- Study dates
- Nov 2013to May 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects' parent/legally acceptable representative/guardian must give written informed consent to participate in the study and must understand the nature of the study and must be willing to comply with all protocol requirements. Subjects over 12 must provide assent to participate in the study and potential subjects below this age should provide assent if deemed appropriate to the maturity level of the subject or if required according to local guidance/regulations.
- Males or females aged between 5 and 17 years inclusive, who weigh at least 15 kg at screening.
- Confirmed influenza infection based on positive rapid antigen test (RAT) for Influenza A or B.
- Fever, defined as either:
- Otic temperature ≥38.0° C (100.4°F) 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.
Show all 18Show fewer
- Presence on the Screening questionnaire of, at least two, of the following influenza symptoms:
- Non-productive Cough, of at least moderate severity,
- Sore throat, of at least moderate severity,
- Nasal congestion/runny nose, of at least moderate severity,
- Headache, of at least moderate severity,
- Muscle aches and pain, of at least moderate severity,
- Feeling feverish, of at least moderate severity,
- Low energy, tired, fatigue, of at least moderate severity;
- Onset of illness no more than 40 hours before randomization, defined as:
- time when the temperature was first measured as elevated ≥38.0°C (oral or otic) OR
- time when the subject first experienced at least one influenza symptom (non-productive cough, sore throat or nasal congestion/runny nose, headache, muscle aches and pain, feeling feverish, or low energy/tired/fatigue)
- In the Investigator's opinion able to complete the required inhalations of the investigational medicinal product.
Who cannot join
- Use of antiviral treatment for influenza (e.g., zanamivir, oseltamivir, peramivir, rimantadine, or amantadine) within 14 days prior to screening
- Received 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)
- Current asthma requiring treatment, or history of asthma requiring treatment in the last 5 years, or episode of wheezing in the 12 months prior to randomization.
- History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status.
- Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
Show all 12Show fewer
- 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/disease
- Currently hospitalized or any planned hospitalizations within 1 month following the last dose of IMP.
- Current clinical evidence of otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection at any body site
- Severe infection within 30 days prior to screening which required parenteral antibiotic use or hospitalization.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
SoCal Clinical Research Med Group
Bellflower, California, 90706
Blue Ridge Pediatric and Adolescent Medicine Group
Boone, North Carolina, 28607
DePaul Health Center
Bridgeton, Missouri, 63044
Sherif Khamis MD Inc
Canoga Park, California, 91306
Dr Haidar's Clinic
Carriere, Mississippi, 39426
Dayton Children's Hospital
Dayton, Ohio, 45404
Cyn3rgy Research
Gresham, Oregon, 97030
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
A.G.A Clinical Trials
Hialeah, Florida, 33012
Avant Research Assoc.
Houston, Texas, 77052
West Houston Clinical Research Service
Houston, Texas, 77055
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Lafayette Clinical Research Group
Lafayette, Indiana, 47905
Advanced Medical Research
Lakewood, California, 90712
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Madera Family Medical Group
Madera, California, 93637
Dr Santiago Reyes
Oklahoma City, Oklahoma, 73112
Precision Trials LLC
Phoenix, Arizona, 85032
Foothill Family Clinic
Salt Lake City, Utah, 84109
First Med
Salt Lake City, Utah, 84121
Foothill Family Clinic South
Salt Lake City, Utah, 84121
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
Sanford Research University of South Dakota
Sioux Falls, South Dakota, 57117
Copperview Medical Center
South Jordan, Utah, 84095
Rockwood Clinic
Spokane, Washington, 99202
Rockwood North Clinic
Spokane, Washington, 99218
Dixie Pediatrics
St. George, Utah, 84790
The University of Toledo Medical Center
Toledo, Ohio, 43606
About this study
Official title: Randomised, Parallel Dose, Phase 1/2 Safety and Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Naturally Acquired Influenza A or B
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.
Read the detailed description
Approximately 48 subjects aged 5-17 years inclusive will be randomised into the study.
Subjects with recent onset of presumptive influenza will have influenza A or B infection confirm by Rapid Antigen Test.
The study will be conducted on an outpatient basis. The dose is administered in a single session in the clinic on Day 1. The subject will return to the clinic for assessments and follow up.
- Conditions
- Influenza
- Being tested
- 20 mg laninamivir octanoate, Placebo, 40 mg laninamivir octanoate
- Keywords
- Influenza treatment, pediatric, laninamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg laninamivir octanoateDrug
Also called CS-8958
PlaceboDrug
Also called Lactose
40 mg laninamivir octanoateDrug
Also called CS-8958
| Study group | Role | What they receive |
|---|---|---|
| 20mg Laninamivir Octanoate | Experimental | Dry Powder plus placebo Receives: Drug: 20 mg laninamivir octanoate; Drug: Placebo |
| 40mg Laninamivir Octanoate | Experimental | Dry Powder Receives: Drug: 40 mg laninamivir octanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate Time to First Alleviation of a Composite of Influenza Symptoms and Absence of Fever.
For subjects aged 5 through 12 years, the subject or parent/legal guardian completed the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom diary and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit. Subjects aged 13 through 17 years completed the Influenza Symptom Questionnaire (ISQ) themselves and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit.
Measured: Subjects are assessed at clinic visits and followed up to 28-days post dose.
Secondary outcomes (1)
To Evaluate the Pharmacokinetic (PK) Profiles (Concentration) of the Prodrug, Laninamivir Octanoate, and Its Active Metabolite, Laninamivir, Following Administration of a Single Dose (20 or 40 mg)
Pharmacokinetic parameters will be calculated and summarized, PK concentration data will add to population models.
Measured: Samples are collected at clinic visits over 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionMay 2014
Why it stopped: Study was terminated as per BARDA decision to terminate contract.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Scientific Management Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Jolanta Airey, Dr, Study director, Biota Scientific Management Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014649
- Sponsor's protocol ID
- BTA51-350-203
- Other IDs
- U1111-1150-7392
- Acronym
- FROSTY
- Status last verified
- Jan 2025
- First submitted
- 24 Nov 2013
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Parallel Dose, Phase 1/2 Safety and Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Naturally Acquired Influenza A or B
- ClinicalTrials.gov ID
- NCT02014649
- Acronym / sponsor ID
- FROSTY / BTA51-350-203
- Conditions
- Influenza
- Keywords
- Influenza treatment, pediatric, laninamivir
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated as per BARDA decision to terminate contract.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Biota Scientific Management Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.
Detailed description
Approximately 48 subjects aged 5-17 years inclusive will be randomised into the study.
Subjects with recent onset of presumptive influenza will have influenza A or B infection confirm by Rapid Antigen Test.
The study will be conducted on an outpatient basis. The dose is administered in a single session in the clinic on Day 1. The subject will return to the clinic for assessments and follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20mg Laninamivir Octanoate | Experimental | Drug: 20 mg laninamivir octanoate, Drug: PlaceboDry Powder plus placebo |
| 40mg Laninamivir Octanoate | Experimental | Drug: 40 mg laninamivir octanoateDry Powder |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Subjects' parent/legally acceptable representative/guardian must give written informed consent to participate in the study and must understand the nature of the study and must be willing to comply with all protocol requirements. Subjects over 12 must provide assent to participate in the study and potential subjects below this age should provide assent if deemed appropriate to the maturity level of the subject or if required according to local guidance/regulations.
- Males or females aged between 5 and 17 years inclusive, who weigh at least 15 kg at screening.
- Confirmed influenza infection based on positive rapid antigen test (RAT) for Influenza A or B.
- Fever, defined as either:
- Presence on the Screening questionnaire of, at least two, of the following influenza symptoms:
Key exclusion criteria (12 listed)
- Use of antiviral treatment for influenza (e.g., zanamivir, oseltamivir, peramivir, rimantadine, or amantadine) within 14 days prior to screening
- Received 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)
- Current asthma requiring treatment, or history of asthma requiring treatment in the last 5 years, or episode of wheezing in the 12 months prior to randomization.
- History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 mg laninamivir octanoateAlso: CS-8958 | Drug | 20mg Laninamivir Octanoate |
| PlaceboAlso: Lactose | Drug | 20mg Laninamivir Octanoate |
| 40 mg laninamivir octanoateAlso: CS-8958 | Drug | 40mg Laninamivir Octanoate |
Primary outcome
To Evaluate Time to First Alleviation of a Composite of Influenza Symptoms and Absence of Fever.
Time frame: Subjects are assessed at clinic visits and followed up to 28-days post dose.
For subjects aged 5 through 12 years, the subject or parent/legal guardian completed the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom diary and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit. Subjects aged 13 through 17 years completed the Influenza Symptom Questionnaire (ISQ) themselves and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit.
1 secondary outcome
To Evaluate the Pharmacokinetic (PK) Profiles (Concentration) of the Prodrug, Laninamivir Octanoate, and Its Active Metabolite, Laninamivir, Following Administration of a Single Dose (20 or 40 mg)
Time frame: Samples are collected at clinic visits over 5 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolanta Airey, Dr study director
Biota Scientific Management Pty Ltd
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 20 mg laninamivir octanoate and 40 mg laninamivir octanoate in people with Influenza, run by Biota Scientific Management Pty Ltd at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate Time to First Alleviation of a Composite of Influenza Symptoms and Absence of Fever. (time frame: Subjects are assessed at clinic visits and followed up to 28-days post dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.