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

NCT02014649 | Terminated Phase 1 Results DMC

• 2 other identifiers: BTA51-350-203U1111-1150-7392
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 28

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.

Conditions

Influenza

Keywords

Influenza treatment; pediatric; laninamivir

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Samples are collected at clinic visits over 5 days.

Study Arms (2)

20mg Laninamivir Octanoate

EXPERIMENTAL

Dry Powder plus placebo

Drug: 20 mg laninamivir octanoate; Drug: Placebo

40mg Laninamivir Octanoate

EXPERIMENTAL

Dry Powder

Drug: 40 mg laninamivir octanoate

Interventions

20 mg laninamivir octanoate DRUG

Also known as: CS-8958

20mg Laninamivir Octanoate

Placebo DRUG

Also known as: Lactose

20mg Laninamivir Octanoate

40 mg laninamivir octanoate DRUG

Also known as: CS-8958

40mg Laninamivir Octanoate

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biota Scientific Management Pty Ltd: lead
• Department of Health and Human Services: collaborator

Study Sites (28)

Precision Trials LLC

Phoenix, Arizona, 85032, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

SoCal Clinical Research Med Group

Bellflower, California, 90706, United States

Location

Sherif Khamis MD Inc

Canoga Park, California, 91306, United States

Location

Advanced Medical Research

Lakewood, California, 90712, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

A.G.A Clinical Trials

Hialeah, Florida, 33012, United States

Location

Lafayette Clinical Research Group

Lafayette, Indiana, 47905, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Dr Haidar's Clinic

Carriere, Mississippi, 39426, United States

Location

DePaul Health Center

Bridgeton, Missouri, 63044, United States

Location

Blue Ridge Pediatric and Adolescent Medicine Group

Boone, North Carolina, 28607, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

The University of Toledo Medical Center

Toledo, Ohio, 43606, United States

Location

Dr Santiago Reyes

Oklahoma City, Oklahoma, 73112, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Sanford Research University of South Dakota

Sioux Falls, South Dakota, 57117, United States

Location

Avant Research Assoc.

Houston, Texas, 77052, United States

Location

West Houston Clinical Research Service

Houston, Texas, 77055, United States

Location

Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

First Med

Salt Lake City, Utah, 84121, United States

Location

Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Copperview Medical Center

South Jordan, Utah, 84095, United States

Location

Dixie Pediatrics

St. George, Utah, 84790, United States

Location

Rockwood Clinic

Spokane, Washington, 99202, United States

Location

Rockwood North Clinic

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

laninamivir; CS 8958; Lactose

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Limitations and Caveats

Sponsor's decision to terminate the study based on funding considerations and equivocal results from a Phase 2 study in adults (BTA51-350-201). As a result, the full prospectively planned efficacy analyses were not completed.

Results Point of Contact

• Title: Anna Novotney-Barry
• Organization: Aviragen Therapeutics, Inc.

abarry@aviragentherapeutics.com

678-221-3356

Study Officials

• Jolanta Airey, Dr

  Biota Scientific Management Pty Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 18, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Locations

US (28)