Clinical trial NCT02014649: Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Influenza treatment
pediatric
laninamivir
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2013-12-18
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: To Evaluate Time to First Alleviation of a Composite of Influenza Symptoms and Absence of Fever.
timeFrame: Subjects are assessed at clinic visits and followed up to 28-days post dose.
Secondary outcomes:
measure: 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)
timeFrame: Samples are collected at clinic visits over 5 days.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials LLC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Bellflower
country: United States
facility: SoCal Clinical Research Med Group
state: California
city: Canoga Park
country: United States
facility: Sherif Khamis MD Inc
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Hialeah
country: United States
facility: A.G.A Clinical Trials
state: Florida
city: Lafayette
country: United States
facility: Lafayette Clinical Research Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Carriere
country: United States
facility: Dr Haidar's Clinic
state: Mississippi
city: Bridgeton
country: United States
facility: DePaul Health Center
state: Missouri
city: Boone
country: United States
facility: Blue Ridge Pediatric and Adolescent Medicine Group
state: North Carolina
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Dr Santiago Reyes
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Sioux Falls
country: United States
facility: Sanford Research University of South Dakota
state: South Dakota
city: Houston
country: United States
facility: Avant Research Assoc.
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Saint George
country: United States
facility: Dixie Pediatrics
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: First Med
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: Copperview Medical Center
state: Utah
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
city: Spokane
country: United States
facility: Rockwood North Clinic
state: Washington
Study officials:
affiliation: Biota Scientific Management Pty Ltd
name: Jolanta Airey, Dr
role: STUDY_DIRECTOR
References: