Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: 40 mg Laninamivir Octanoate; 80 mg Laninamivir Octanoate; Placebo
Intervention MeSH terms: Laninamivir; Zanamivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 639.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Influenza Laninamivir Octanoate

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.
    

Eligibility criteria:

        Main 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