Trial Outcomes & Findings for Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza (NCT NCT01793883)
NCT ID: NCT01793883
Last Updated: 2018-05-31
Results Overview
Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
639 participants
Primary outcome timeframe
Efficacy will be assessed over 14 days post-randomization.
Results posted on
2018-05-31
Participant Flow
Participant milestones
| Measure |
40 mg Laninamivir Octanoate DPI
40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo
|
80 mg Laninamivir Octanoate DPI
80 mg Laninamivir
80 mg Laninamivir Octanoate
|
Placebo
Matching Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
213
|
214
|
212
|
|
Overall Study
COMPLETED
|
201
|
204
|
204
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
8
|
Reasons for withdrawal
| Measure |
40 mg Laninamivir Octanoate DPI
40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo
|
80 mg Laninamivir Octanoate DPI
80 mg Laninamivir
80 mg Laninamivir Octanoate
|
Placebo
Matching Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
3
|
|
Overall Study
Subject noncompliance
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
3
|
|
Overall Study
Randomized in error
|
1
|
0
|
0
|
|
Overall Study
Unable to complete spriometry
|
1
|
0
|
0
|
|
Overall Study
Unable to complete measurements
|
1
|
0
|
0
|
|
Overall Study
Met exclusion criteria
|
1
|
0
|
0
|
|
Overall Study
Dosing error
|
0
|
1
|
0
|
|
Overall Study
Respiratory distress during spirometry
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
Baseline characteristics by cohort
| Measure |
40 mg Laninamivir Octanoate DPI
n=213 Participants
40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo
|
80 mg Laninamivir Octanoate DPI
n=214 Participants
80 mg Laninamivir
80 mg Laninamivir Octanoate
|
Placebo
n=212 Participants
Matching Placebo
Placebo
|
Total
n=639 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 11.95 • n=99 Participants
|
39.2 years
STANDARD_DEVIATION 12.49 • n=107 Participants
|
40.3 years
STANDARD_DEVIATION 13.31 • n=206 Participants
|
39.3 years
STANDARD_DEVIATION 12.60 • n=7 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
362 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
277 Participants
n=7 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=99 Participants
|
97 participants
n=107 Participants
|
84 participants
n=206 Participants
|
283 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
New Zealand
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Region of Enrollment
Latvia
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
13 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=99 Participants
|
12 participants
n=107 Participants
|
10 participants
n=206 Participants
|
29 participants
n=7 Participants
|
|
Region of Enrollment
South Africa
|
40 participants
n=99 Participants
|
38 participants
n=107 Participants
|
39 participants
n=206 Participants
|
117 participants
n=7 Participants
|
|
Region of Enrollment
Bulgaria
|
27 participants
n=99 Participants
|
32 participants
n=107 Participants
|
36 participants
n=206 Participants
|
95 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
13 participants
n=7 Participants
|
|
Region of Enrollment
Estonia
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
15 participants
n=206 Participants
|
39 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Efficacy will be assessed over 14 days post-randomization.Population: Intent-to-treat-infected (ITT-I) population - all ITT subjects with laboratory confirmed influenza A or B infection by at least one virological method (qRT-PCR or qCulture) on either Day 1 or 3
Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.
Outcome measures
| Measure |
40 mg Laninamivir Octanoate DPI
n=67 Participants
40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo
|
80 mg Laninamivir Octanoate DPI
n=75 Participants
80 mg Laninamivir
80 mg Laninamivir Octanoate
|
Placebo
n=89 Participants
Matching Placebo
Placebo
|
|---|---|---|---|
|
Time to Alleviation of Influenza Symptoms
|
102.30 hours
Interval 80.6 to 114.8
|
103.20 hours
Interval 89.0 to 138.3
|
104.10 hours
Interval 93.0 to 140.7
|
Adverse Events
40 mg Laninamivir Octanoate DPI
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
80 mg Laninamivir Octanoate DPI
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
40 mg Laninamivir Octanoate DPI
n=212 participants at risk
40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo
|
80 mg Laninamivir Octanoate DPI
n=211 participants at risk
80 mg Laninamivir Octanoate
80 mg Laninamivir Octanoate
|
Placebo
n=211 participants at risk
Matching Placebo
Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.47%
1/212 • Number of events 1 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.00%
0/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.00%
0/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Infections and infestations
Bronchitis bacterial
|
0.47%
1/212 • Number of events 1 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.00%
0/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.00%
0/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.47%
1/211 • Number of events 1 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.00%
0/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.00%
0/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.47%
1/211 • Number of events 1 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
Other adverse events
| Measure |
40 mg Laninamivir Octanoate DPI
n=212 participants at risk
40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo
|
80 mg Laninamivir Octanoate DPI
n=211 participants at risk
80 mg Laninamivir Octanoate
80 mg Laninamivir Octanoate
|
Placebo
n=211 participants at risk
Matching Placebo
Placebo
|
|---|---|---|---|
|
Infections and infestations
Bronchitis bacterial
|
2.8%
6/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
2.8%
6/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
4.3%
9/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
10/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
1.9%
4/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
2.8%
6/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
9/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
2.4%
5/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
1.4%
3/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
8/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
2.8%
6/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.95%
2/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Nervous system disorders
Headache
|
3.3%
7/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.95%
2/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
1.4%
3/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.47%
1/212 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
3.3%
7/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
0.47%
1/211 • Period of time was defined as from Day 1 to Day 15.
All-Cause Mortality data was collected for all randomized participants. Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected for the Safety Analysis Set, which was defined as all patients who received at least 1 dose of study drug and had at least 1 safety assessment after randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place