Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza

Phase 2

Completed

• Conditions: Influenza
• Interventions: Drug: 40 mg Laninamivir Octanoate; Drug: 80 mg Laninamivir Octanoate; Drug: Placebo

• Registration Number: NCT01793883
• Lead Sponsor: Biota Scientific Management Pty Ltd

Brief Summary

This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

Detailed Description

Approximately 636 subjects will be randomized into the Study.

Following confirmation of circulating influenza in the local area, eligible subjects with recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will be randomized to placebo, 40 or 80 mg of laninamivir octanoate.

The study will be conducted on an outpatient basis. The first dose of study drug will be administered via inhalation within 4 hours of randomization in the clinic, followed by a second dose at home. Participants will be followed for 14 days to assess efficacy, virology and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.

Study Timeline

• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-18
• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Disposition First Submitted: 2015-09-17
• Disposition First Submitted QC: 2015-09-17
• Disposition First Posted: 2015-10-05
• Results First Submitted: 2017-07-31
• Results First Submitted QC: 2017-08-31
• Results First Posted: 2017-09-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 639

Inclusion Criteria

1. Provide written informed consent

2. Males or females aged 18-64 years, inclusive

3. Symptomatic presumptive influenza A or B infection defined as the presence of:

   1. a fever of ≥38.0ºC (≥100.4 ºF) 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 AND
   2. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
   3. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)

4. Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred:

   1. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
   2. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
   3. time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)

Main

Exclusion Criteria

1. Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
2. Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks.
3. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma
4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months
5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
6. Presence of clinically significant signs of acute respiratory distress during screening
7. Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.
8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min
9. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 mg Laninamivir Octanoate DPI	40 mg Laninamivir Octanoate	40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate DPI	Placebo	40 mg Laninamivir Octanoate and matching placebo
80 mg Laninamivir Octanoate DPI	80 mg Laninamivir Octanoate	80 mg Laninamivir
Placebo	Placebo	Matching Placebo

Primary Outcome Measures

Name	Time	Method
Time to Alleviation of Influenza Symptoms	Efficacy will be assessed over 14 days post-randomization.	Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.

Trial Locations

Locations (207)

Scottsboro Quick Care Clinic; 🇺🇸 Scottsboro, Alabama, United States

Clinical Trial Connection; 🇺🇸 Camp Verde, Arizona, United States

Warner Family Practice; 🇺🇸 Chandler, Arizona, United States

Clinical Research Connections, LLC; 🇺🇸 Harrisburg, Arkansas, United States

NEA Baptist Clinic; 🇺🇸 Jonesboro, Arkansas, United States

eStudySite; 🇺🇸 Las Vegas, Nevada, United States

Beach Physicians Medical Group, Inc.; 🇺🇸 Huntington Beach, California, United States

Novo Research, Inc.; 🇺🇸 Long Beach, California, United States

Lucita M. Cruz, MD, Inc; 🇺🇸 Norwalk, California, United States

Clinical Trials of Orange County, Inc; 🇺🇸 Orange, California, United States

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