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

Influenza Clinical Trial

— FROSTY  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02014649
• Other study ID #: BTA51-350-203
• Secondary ID: U1111-1150-7392
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 24, 2013
• Last updated: March 22, 2016
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2016
• Source: Aviragen Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• 20 mg laninamivir octanoate

• Placebo

• 40 mg laninamivir octanoate

Locations

Country	Name	City	State
United States	SoCal Clinical Research Med Group	Bellflower	California
United States	Blue Ridge Pediatric and Adolescent Medicine Group	Boone	North Carolina
United States	DePaul Health Center	Bridgeton	Missouri
United States	Sherif Khamis MD Inc	Canoga Park	California
United States	Dr Haidar's Clinic	Carriere	Mississippi
United States	Dayton Children's Hospital	Dayton	Ohio
United States	Cyn3rgy Research	Gresham	Oregon
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	A.G.A Clinical Trials	Hialeah	Florida
United States	Avant Research Assoc.	Houston	Texas
United States	West Houston Clinical Research Service	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Lafayette Clinical Research Group	Lafayette	Indiana
United States	Advanced Medical Research	Lakewood	California
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Madera Family Medical Group	Madera	California
United States	Dr Santiago Reyes	Oklahoma	Oklahoma
United States	Precision Trials LLC	Phoenix	Arizona
United States	First Med	Salt Lake City	Utah
United States	Foothill Family Clinic	Salt Lake City	Utah
United States	Foothill Family Clinic South	Salt Lake City	Utah
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	Sanford Research University of South Dakota	Sioux Falls	South Dakota
United States	Copperview Medical Center	South Jordan	Utah
United States	Rockwood Clinic	Spokane	Washington
United States	Rockwood North Clinic	Spokane	Washington
United States	Dixie Pediatrics	St. George	Utah
United States	The University of Toledo Medical Center	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Biota Scientific Management Pty Ltd	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of laninamivir octanoate following administration of the dose by inhalation in children with influenza A or B infection	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.	Subjects are assessed at clinic visits and followed up to 28-days post dose.
Secondary	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)	Pharmacokinetic parameters will be calculated and summarized, PK concentration data will add to population models.	Samples are collected at clinic visits over 5 days.