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
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
1565
mi
from 98109
Tulsa, OK
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
2389
mi
from 98109
Berlin, NJ
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304 Northeast 1st Street
Chiefland, Florida 32626
2437
mi
from 98109
Chiefland, FL
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
2536
mi
from 98109
Port Orange, FL
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6699 Alvarado Rd.
San Diego, California 92120
619-229-3920
1063
mi
from 98109
San Diego, CA
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Bangor, Maine 04401
2516
mi
from 98109
Bangor, ME
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Bellevue, Nebraska 68005
1372
mi
from 98109
Bellevue, NE
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Bellevue, Nebraska 68123
1371
mi
from 98109
Bellevue, NE
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2315
mi
from 98109
Bethesda, MD
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2709
mi
from 98109
Boca Raton, FL
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Boynton Beach, Florida 33437
2697
mi
from 98109
Boynton Beach, FL
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Burwood, New South Wales 2134
7753
mi
from 98109
Burwood,
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Camp Verde, Arizona 86322
1053
mi
from 98109
Camp Verde, AZ
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Chandler, Arizona 85224
1128
mi
from 98109
Chandler, AZ
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Chula Vista, California 91911
1074
mi
from 98109
Chula Vista, CA
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1967
mi
from 98109
Cincinnati, OH
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Clinton, Utah 84015
677
mi
from 98109
Clinton, UT
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Columbia, Tennessee 38401
1981
mi
from 98109
Columbia, TN
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Coral Gables, Florida 33134
2730
mi
from 98109
Coral Gables, FL
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Draper, Utah 84020
715
mi
from 98109
Draper, UT
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Fall River, Massachusetts 02720
2502
mi
from 98109
Fall River, MA
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Franklin, Tennessee 37064
1976
mi
from 98109
Franklin, TN
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1976
mi
from 98109
Franklin, TN
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Fremont, Nebraska 68025
1335
mi
from 98109
Fremont, NE
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Harrisburg, Arkansas 72432
1817
mi
from 98109
Harrisburg, AR
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Hickory, North Carolina 28602
2238
mi
from 98109
Hickory, NC
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Huntington Beach, California 92647
987
mi
from 98109
Huntington Beach, CA
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Idaho Falls, Idaho 83404
577
mi
from 98109
Idaho Falls, ID
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Jackson, Tennessee 37805
1900
mi
from 98109
Jackson, TN
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Jacksonville, Florida 32216
2458
mi
from 98109
Jacksonville, FL
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Jonesboro, Arkansas 72401
1806
mi
from 98109
Jonesboro, AR
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Knoxville, Tennessee 37912
2110
mi
from 98109
Knoxville, TN
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La Mesa, California 91942
1063
mi
from 98109
La Mesa, CA
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Lansdale, Pennsylvania 19446
2358
mi
from 98109
Lansdale, PA
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Las Vegas, Nevada 89109
876
mi
from 98109
Las Vegas, NV
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Long Beach, California 90813
982
mi
from 98109
Long Beach, CA
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Madisonville, Kentucky 42431
1893
mi
from 98109
Madisonville, KY
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Mandeville, Louisiana 70471
2079
mi
from 98109
Mandeville, LA
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Metairie, Louisiana 70006
2091
mi
from 98109
Metairie, LA
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Metairie, Louisiana 70006
2090
mi
from 98109
Metairie, LA
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Miami, Florida 33174
2732
mi
from 98109
Miami, FL
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Miami, Florida 33175
2732
mi
from 98109
Miami, FL
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Miami Lakes, Florida 33014
2720
mi
from 98109
Miami Lakes, FL
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1974
mi
from 98109
Milford, OH
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Nashville, Tennessee 37211
1976
mi
from 98109
Nashville, TN
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Natchitoches, Louisiana 71457
1884
mi
from 98109
Natchitoches, LA
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Northglenn, Colorado
1013
mi
from 98109
Northglenn, CO
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Norwalk, California 90650
973
mi
from 98109
Norwalk, CA
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Oceanside, California 92056
1031
mi
from 98109
Oceanside, CA
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Olive Branch, Mississippi 38654
1882
mi
from 98109
Olive Branch, MS
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Orange, California 92868
984
mi
from 98109
Orange, CA
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2549
mi
from 98109
Orlando, FL
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5425 West Spring Creek Parkway
Plano, Texas 75024
1666
mi
from 98109
Plano, TX
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Roanoke, Virginia 24014
2248
mi
from 98109
Roanoke, VA
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Salt Lake City, Utah 84121
711
mi
from 98109
Salt Lake City, UT
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San Antonio, Texas 78221
1793
mi
from 98109
San Antonio, TX
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1776
mi
from 98109
San Antonio, TX
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San Antonio, Texas 78128
1787
mi
from 98109
San Antonio, TX
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San Antonio, Texas 78215
1786
mi
from 98109
San Antonio, TX
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San Diego, California 92103
1063
mi
from 98109
San Diego, CA
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Scottsboro, Alabama 35768
2063
mi
from 98109
Scottsboro, AL
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Simpsonville, South Carolina 29681
2235
mi
from 98109
Simpsonville, SC
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Smyrna, Tennessee 37167
1990
mi
from 98109
Smyrna, TN
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Snellville, Georgia 30039
2193
mi
from 98109
Snellville, GA
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Sylvania, Ohio 43560
1920
mi
from 98109
Sylvania, OH
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Troy, Michigan 48085
1922
mi
from 98109
Troy, MI
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Tustin, California
988
mi
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Tustin, CA
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Upland, California 91786
966
mi
from 98109
Upland, CA
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Warminster, Pennsylvania 18974
2367
mi
from 98109
Warminster, PA
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Warwick, Rhode Island 02886
2487
mi
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Warwick, RI
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Worcester, Massachusetts 01655
2455
mi
from 98109
Worcester, MA
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