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

Use our guide to learn which trials are right for you!

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
413
mi
from
Northglenn, CO
Click here to add this to my saved trials
175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
1237
mi
from
Berlin, NJ
Click here to add this to my saved trials
304 Northeast 1st Street
Chiefland, Florida 32626
1031
mi
from
Chiefland, FL
Click here to add this to my saved trials
1690 Dunlawton Ave # 220
Port Orange, Florida 32127
1134
mi
from
Port Orange, FL
Click here to add this to my saved trials
6699 Alvarado Rd.
San Diego, California 92120
619-229-3920
1135
mi
from
San Diego, CA
Click here to add this to my saved trials
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
156
mi
from
Tulsa, OK
Click here to add this to my saved trials
Bangor, Maine 04401
1575
mi
from
Bangor, ME
Click here to add this to my saved trials
Bellevue, Nebraska 68005
255
mi
from
Bellevue, NE
Click here to add this to my saved trials
Bellevue, Nebraska 68123
256
mi
from
Bellevue, NE
Click here to add this to my saved trials
1122
mi
from
Bethesda, MD
Click here to add this to my saved trials
1300
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Boynton Beach, Florida 33437
1288
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Burwood, New South Wales 2134
8654
mi
from
Burwood,
Click here to add this to my saved trials
Camp Verde, Arizona 86322
812
mi
from
Camp Verde, AZ
Click here to add this to my saved trials
Chandler, Arizona 85224
846
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chula Vista, California 91911
1140
mi
from
Chula Vista, CA
Click here to add this to my saved trials
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clinton, Utah 84015
792
mi
from
Clinton, UT
Click here to add this to my saved trials
Columbia, Tennessee 38401
615
mi
from
Columbia, TN
Click here to add this to my saved trials
Coral Gables, Florida 33134
1319
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Draper, Utah 84020
775
mi
from
Draper, UT
Click here to add this to my saved trials
Fall River, Massachusetts 02720
1437
mi
from
Fall River, MA
Click here to add this to my saved trials
Franklin, Tennessee 37064
618
mi
from
Franklin, TN
Click here to add this to my saved trials
618
mi
from
Franklin, TN
Click here to add this to my saved trials
Fremont, Nebraska 68025
263
mi
from
Fremont, NE
Click here to add this to my saved trials
Harrisburg, Arkansas 72432
421
mi
from
Harrisburg, AR
Click here to add this to my saved trials
Hickory, North Carolina 28602
922
mi
from
Hickory, NC
Click here to add this to my saved trials
Huntington Beach, California 92647
1162
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
839
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Jackson, Tennessee 37805
519
mi
from
Jackson, TN
Click here to add this to my saved trials
Jacksonville, Florida 32216
1061
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
416
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Knoxville, Tennessee 37912
777
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Mesa, California 91942
1133
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lansdale, Pennsylvania 19446
1219
mi
from
Lansdale, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89109
961
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Long Beach, California 90813
1172
mi
from
Long Beach, CA
Click here to add this to my saved trials
Madisonville, Kentucky 42431
566
mi
from
Madisonville, KY
Click here to add this to my saved trials
Mandeville, Louisiana 70471
674
mi
from
Mandeville, LA
Click here to add this to my saved trials
Metairie, Louisiana 70006
690
mi
from
Metairie, LA
Click here to add this to my saved trials
Metairie, Louisiana 70006
688
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33174
1321
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33175
1321
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
1309
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
737
mi
from
Milford, OH
Click here to add this to my saved trials
Nashville, Tennessee 37211
623
mi
from
Nashville, TN
Click here to add this to my saved trials
Natchitoches, Louisiana 71457
493
mi
from
Natchitoches, LA
Click here to add this to my saved trials
Norwalk, California 90650
1162
mi
from
Norwalk, CA
Click here to add this to my saved trials
Oceanside, California 92056
1138
mi
from
Oceanside, CA
Click here to add this to my saved trials
Olive Branch, Mississippi 38654
484
mi
from
Olive Branch, MS
Click here to add this to my saved trials
Orange, California 92868
1154
mi
from
Orange, CA
Click here to add this to my saved trials
1144
mi
from
Orlando, FL
Click here to add this to my saved trials
5425 West Spring Creek Parkway
Plano, Texas 75024
328
mi
from
Plano, TX
Click here to add this to my saved trials
Roanoke, Virginia 24014
981
mi
from
Roanoke, VA
Click here to add this to my saved trials
Salt Lake City, Utah 84121
774
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78221
585
mi
from
San Antonio, TX
Click here to add this to my saved trials
561
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78128
576
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78215
575
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
1142
mi
from
San Diego, CA
Click here to add this to my saved trials
Scottsboro, Alabama 35768
687
mi
from
Scottsboro, AL
Click here to add this to my saved trials
Simpsonville, South Carolina 29681
890
mi
from
Simpsonville, SC
Click here to add this to my saved trials
Smyrna, Tennessee 37167
636
mi
from
Smyrna, TN
Click here to add this to my saved trials
Snellville, Georgia 30039
819
mi
from
Snellville, GA
Click here to add this to my saved trials
Sylvania, Ohio 43560
797
mi
from
Sylvania, OH
Click here to add this to my saved trials
Troy, Michigan 48085
843
mi
from
Troy, MI
Click here to add this to my saved trials
Tustin, California
1152
mi
from
Tustin, CA
Click here to add this to my saved trials
Upland, California 91786
1135
mi
from
Upland, CA
Click here to add this to my saved trials
Warminster, Pennsylvania 18974
1228
mi
from
Warminster, PA
Click here to add this to my saved trials
Warwick, Rhode Island 02886
1421
mi
from
Warwick, RI
Click here to add this to my saved trials
Worcester, Massachusetts 01655
1408
mi
from
Worcester, MA
Click here to add this to my saved trials