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Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza (FROSTY)

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ClinicalTrials.gov Identifier: NCT02014649
Recruitment Status : Terminated (Study was terminated as per BARDA decision to terminate contract.)
First Posted : December 18, 2013
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Vaxart ( Biota Scientific Management Pty Ltd )

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Drug: 20 mg laninamivir octanoate Drug: Placebo Drug: 40 mg laninamivir octanoate Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 20mg Laninamivir Octanoate
Dry Powder plus placebo
Drug: 20 mg laninamivir octanoate
Other Name: CS-8958

Drug: Placebo
Other Name: Lactose

Experimental: 40mg Laninamivir Octanoate
Dry Powder
Drug: 40 mg laninamivir octanoate
Other Name: CS-8958




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of laninamivir octanoate following administration of the dose by inhalation in children with influenza A or B infection [ Time Frame: Subjects are assessed at clinic visits and followed up to 28-days post dose. ]
    Safety data will be presented according to dose group and age strata. All safety data will be summarized with descriptive statistics, and include assessment of SAEs, AEs, Clinically Significant changes in routine labs, O2 Saturation, ECG, Vitals, Con Meds, Physical Exam findings.


Secondary Outcome Measures :
  1. To evaluate the pharmacokinetic (PK) profiles 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. ]
    Pharmacokinetic parameters will be calculated and summarized, PK concentration data will add to population models.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Otic temperature ≥38.0° C (100.4°F) at the screening visit, OR,
    2. 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.
  • Presence on the Screening questionnaire of, at least two, of the following influenza symptoms:

    1. Non-productive Cough, of at least moderate severity,
    2. Sore throat, of at least moderate severity,
    3. Nasal congestion/runny nose, of at least moderate severity,
    4. Headache, of at least moderate severity,
    5. Muscle aches and pain, of at least moderate severity,
    6. Feeling feverish, of at least moderate severity,
    7. Low energy, tired, fatigue, of at least moderate severity;
  • Onset of illness no more than 40 hours before randomization, defined as:

    1. time when the temperature was first measured as elevated ≥38.0°C (oral or otic) OR
    2. 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.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014649


Locations
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Sponsors and Collaborators
Biota Scientific Management Pty Ltd
Department of Health and Human Services
Investigators
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Study Director: Jolanta Airey, Dr Biota Scientific Management Pty Ltd
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Responsible Party: Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier: NCT02014649    
Other Study ID Numbers: BTA51-350-203
U1111-1150-7392 ( Other Identifier: WHO )
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: March 2016
Keywords provided by Vaxart ( Biota Scientific Management Pty Ltd ):
Influenza treatment
pediatric
laninamivir
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Laninamivir
Zanamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action