Trial Outcomes & Findings for Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza (NCT NCT02014649)
NCT ID: NCT02014649
Last Updated: 2025-01-13
Results Overview
For subjects aged 5 through 12 years, the subject or parent/legal guardian completed the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom diary and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit. Subjects aged 13 through 17 years completed the Influenza Symptom Questionnaire (ISQ) themselves and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit.
TERMINATED
PHASE1/PHASE2
15 participants
Subjects are assessed at clinic visits and followed up to 28-days post dose.
2025-01-13
Participant Flow
Participant milestones
| Measure |
20mg Laninamivir Octanoate
Dry Powder plus placebo
20 mg laninamivir octanoate
Placebo
|
40mg Laninamivir Octanoate
Dry Powder
40 mg laninamivir octanoate
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza
Baseline characteristics by cohort
| Measure |
20mg Laninamivir Octanoate
n=7 Participants
Dry Powder plus placebo
20 mg laninamivir octanoate
Placebo
|
40mg Laninamivir Octanoate
n=8 Participants
Dry Powder
40 mg laninamivir octanoate
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 3.77 • n=5 Participants
|
9.8 years
STANDARD_DEVIATION 2.82 • n=7 Participants
|
9.1 years
STANDARD_DEVIATION 3.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects are assessed at clinic visits and followed up to 28-days post dose.For subjects aged 5 through 12 years, the subject or parent/legal guardian completed the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom diary and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit. Subjects aged 13 through 17 years completed the Influenza Symptom Questionnaire (ISQ) themselves and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit.
Outcome measures
| Measure |
20mg Laninamivir Octanoate
n=6 Participants
Dry Powder plus placebo
20 mg laninamivir octanoate
Placebo
|
40mg Laninamivir Octanoate
n=8 Participants
Dry Powder
40 mg laninamivir octanoate
|
|---|---|---|
|
To Evaluate Time to First Alleviation of a Composite of Influenza Symptoms and Absence of Fever.
|
85.1 hours
Standard Deviation 34.2
|
79.7 hours
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: Samples are collected at clinic visits over 5 days.Population: Due to early study termination, no PK data were collected.
Pharmacokinetic parameters will be calculated and summarized, PK concentration data will add to population models.
Outcome measures
Outcome data not reported
Adverse Events
20mg Laninamivir Octanoate
40mg Laninamivir Octanoate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
20mg Laninamivir Octanoate
n=7 participants at risk
Dry Powder plus placebo
20 mg laninamivir octanoate
Placebo
|
40mg Laninamivir Octanoate
n=8 participants at risk
Dry Powder
40 mg laninamivir octanoate
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
14.3%
1/7
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/7
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7
|
25.0%
2/8
|
|
Infections and infestations
Otitis Media Bacterial
|
0.00%
0/7
|
12.5%
1/8
|
|
Infections and infestations
Tonsillitis Bacterial
|
14.3%
1/7
|
0.00%
0/8
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
1/7
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
14.3%
1/7
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7
|
12.5%
1/8
|
|
Ear and labyrinth disorders
Tympanic Membrane Disorder
|
0.00%
0/7
|
12.5%
1/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/7
|
12.5%
1/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place