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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:6/2/2018
Start Date:May 2013
End Date:May 2014

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A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection

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.

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.

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
We found this trial at
71
sites
Northglenn, Colorado
1160
mi
from 43215
Northglenn, CO
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
428
mi
from 43215
Berlin, NJ
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304 Northeast 1st Street
Chiefland, Florida 32626
724
mi
from 43215
Chiefland, FL
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
758
mi
from 43215
Port Orange, FL
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6699 Alvarado Rd.
San Diego, California 92120
619-229-3920
1944
mi
from 43215
San Diego, CA
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
750
mi
from 43215
Tulsa, OK
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Bangor, Maine 04401
798
mi
from 43215
Bangor, ME
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Bellevue, Nebraska 68005
679
mi
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Bellevue, NE
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Bellevue, Nebraska 68123
680
mi
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Bellevue, NE
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322
mi
from 43215
Bethesda, MD
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956
mi
from 43215
Boca Raton, FL
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Boynton Beach, Florida 33437
943
mi
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Boynton Beach, FL
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Burwood, New South Wales 2134
9462
mi
from 43215
Burwood,
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Camp Verde, Arizona 86322
1620
mi
from 43215
Camp Verde, AZ
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Chandler, Arizona 85224
1655
mi
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Chandler, AZ
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Chula Vista, California 91911
1949
mi
from 43215
Chula Vista, CA
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98
mi
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Cincinnati, OH
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Clinton, Utah 84015
1518
mi
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Clinton, UT
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Columbia, Tennessee 38401
371
mi
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Columbia, TN
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Coral Gables, Florida 33134
995
mi
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Coral Gables, FL
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Draper, Utah 84020
1515
mi
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Draper, UT
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Fall River, Massachusetts 02720
631
mi
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Fall River, MA
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Franklin, Tennessee 37064
348
mi
from 43215
Franklin, TN
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349
mi
from 43215
Franklin, TN
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Fremont, Nebraska 68025
712
mi
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Fremont, NE
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Harrisburg, Arkansas 72432
518
mi
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Harrisburg, AR
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Hickory, North Carolina 28602
306
mi
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Hickory, NC
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Huntington Beach, California 92647
1968
mi
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Huntington Beach, CA
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Idaho Falls, Idaho 83404
1506
mi
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Idaho Falls, ID
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Jackson, Tennessee 37805
436
mi
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Jackson, TN
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Jacksonville, Florida 32216
673
mi
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Jacksonville, FL
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Jonesboro, Arkansas 72401
505
mi
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Jonesboro, AR
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Knoxville, Tennessee 37912
280
mi
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Knoxville, TN
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La Mesa, California 91942
1942
mi
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La Mesa, CA
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Lansdale, Pennsylvania 19446
409
mi
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Lansdale, PA
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Las Vegas, Nevada 89109
1758
mi
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Las Vegas, NV
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Long Beach, California 90813
1976
mi
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Long Beach, CA
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Madisonville, Kentucky 42431
302
mi
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Madisonville, KY
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Mandeville, Louisiana 70471
772
mi
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Mandeville, LA
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Metairie, Louisiana 70006
797
mi
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Metairie, LA
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Metairie, Louisiana 70006
795
mi
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Metairie, LA
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Miami, Florida 33174
996
mi
from 43215
Miami, FL
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Miami, Florida 33175
996
mi
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Miami, FL
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Miami Lakes, Florida 33014
983
mi
from 43215
Miami Lakes, FL
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86
mi
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Milford, OH
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Nashville, Tennessee 37211
335
mi
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Nashville, TN
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Natchitoches, Louisiana 71457
798
mi
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Natchitoches, LA
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Norwalk, California 90650
1966
mi
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Norwalk, CA
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Oceanside, California 92056
1945
mi
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Oceanside, CA
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Olive Branch, Mississippi 38654
508
mi
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Olive Branch, MS
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Orange, California 92868
1959
mi
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Orange, CA
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797
mi
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Orlando, FL
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5425 West Spring Creek Parkway
Plano, Texas 75024
900
mi
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Plano, TX
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Roanoke, Virginia 24014
253
mi
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Roanoke, VA
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Salt Lake City, Utah 84121
1511
mi
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Salt Lake City, UT
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San Antonio, Texas 78221
1144
mi
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San Antonio, TX
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1126
mi
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San Antonio, TX
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San Antonio, Texas 78128
1138
mi
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San Antonio, TX
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San Antonio, Texas 78215
1137
mi
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San Diego, California 92103
1951
mi
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San Diego, CA
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Scottsboro, Alabama 35768
401
mi
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Scottsboro, AL
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Simpsonville, South Carolina 29681
361
mi
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Simpsonville, SC
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Smyrna, Tennessee 37167
334
mi
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Smyrna, TN
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Snellville, Georgia 30039
429
mi
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Snellville, GA
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Sylvania, Ohio 43560
126
mi
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Sylvania, OH
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Troy, Michigan 48085
181
mi
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Troy, MI
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Tustin, California
1957
mi
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Tustin, CA
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Upland, California 91786
1939
mi
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Upland, CA
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Warminster, Pennsylvania 18974
419
mi
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Warminster, PA
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Warwick, Rhode Island 02886
615
mi
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Warwick, RI
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Worcester, Massachusetts 01655
607
mi
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Worcester, MA
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