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

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ClinicalTrials.gov Identifier: NCT01793883
Recruitment Status : Completed
First Posted : February 18, 2013
Results First Posted : September 1, 2017
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Vaxart ( Biota Scientific Management Pty Ltd )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Influenza
Interventions Drug: 40 mg Laninamivir Octanoate
Drug: 80 mg Laninamivir Octanoate
Drug: Placebo
Enrollment 639
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
Hide Arm/Group Description

40 mg Laninamivir Octanoate and matching placebo

40 mg Laninamivir Octanoate

Placebo

80 mg Laninamivir

80 mg Laninamivir Octanoate

Matching Placebo

Placebo

Period Title: Overall Study
Started 213 214 212
Completed 201 204 204
Not Completed 12 10 8
Reason Not Completed
Withdrawal by Subject             3             7             3
Subject noncompliance             0             1             1
Lost to Follow-up             5             1             3
Randomized in error             1             0             0
Unable to complete spriometry             1             0             0
Unable to complete measurements             1             0             0
Met exclusion criteria             1             0             0
Dosing error             0             1             0
Respiratory distress during spirometry             0             0             1
Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo Total
Hide Arm/Group Description

40 mg Laninamivir Octanoate and matching placebo

40 mg Laninamivir Octanoate

Placebo

80 mg Laninamivir

80 mg Laninamivir Octanoate

Matching Placebo

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 213 214 212 639
Hide Baseline Analysis Population Description
Intent-to-treat population - all subjects who provided informed consent for this study and who had been randomized to the study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 213 participants 214 participants 212 participants 639 participants
38.5  (11.95) 39.2  (12.49) 40.3  (13.31) 39.3  (12.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 214 participants 212 participants 639 participants
Female
119
  55.9%
128
  59.8%
115
  54.2%
362
  56.7%
Male
94
  44.1%
86
  40.2%
97
  45.8%
277
  43.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 213 participants 214 participants 212 participants 639 participants
Hungary 1 1 1 3
United States 102 97 84 283
United Kingdom 1 0 0 1
New Zealand 2 4 3 9
Canada 2 2 3 7
Latvia 1 3 4 8
Belgium 13 8 14 35
Mexico 7 12 10 29
South Africa 40 38 39 117
Bulgaria 27 32 36 95
Germany 6 4 3 13
Estonia 11 13 15 39
1.Primary Outcome
Title Time to Alleviation of Influenza Symptoms
Hide Description Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.
Time Frame Efficacy will be assessed over 14 days post-randomization.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
Hide Arm/Group Description:

40 mg Laninamivir Octanoate and matching placebo

40 mg Laninamivir Octanoate

Placebo

80 mg Laninamivir

80 mg Laninamivir Octanoate

Matching Placebo

Placebo

Overall Number of Participants Analyzed 67 75 89
Median (95% Confidence Interval)
Unit of Measure: hours
102.30
(80.60 to 114.80)
103.20
(89.00 to 138.30)
104.10
(93.00 to 140.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40 mg Laninamivir Octanoate DPI, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.251
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80 mg Laninamivir Octanoate DPI, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.818
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame Period of time was defined as from Day 1 to Day 15.
Adverse Event Reporting Description 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.
 
Arm/Group Title 40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
Hide Arm/Group Description

40 mg Laninamivir Octanoate and matching placebo

40 mg Laninamivir Octanoate

Placebo

80 mg Laninamivir Octanoate

80 mg Laninamivir Octanoate

Matching Placebo

Placebo

All-Cause Mortality
40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/213 (0.00%)      0/214 (0.00%)      0/212 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/212 (0.47%)      1/211 (0.47%)      1/211 (0.47%)    
Gastrointestinal disorders       
Gastritis   1/212 (0.47%)  1 0/211 (0.00%)  0 0/211 (0.00%)  0
Infections and infestations       
Bronchitis bacterial   1/212 (0.47%)  1 0/211 (0.00%)  0 0/211 (0.00%)  0
Gastroenteritis bacterial   0/212 (0.00%)  0 1/211 (0.47%)  1 0/211 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumomediastinum   0/212 (0.00%)  0 0/211 (0.00%)  0 1/211 (0.47%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
40 mg Laninamivir Octanoate DPI 80 mg Laninamivir Octanoate DPI Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/212 (14.62%)      27/211 (12.80%)      21/211 (9.95%)    
Gastrointestinal disorders       
Diarrhoea   8/212 (3.77%)  6/211 (2.84%)  2/211 (0.95%) 
Infections and infestations       
Bronchitis bacterial   6/212 (2.83%)  6/211 (2.84%)  9/211 (4.27%) 
Urinary tract infection   1/212 (0.47%)  7/211 (3.32%)  1/211 (0.47%) 
Nervous system disorders       
Headache   7/212 (3.30%)  2/211 (0.95%)  3/211 (1.42%) 
Respiratory, thoracic and mediastinal disorders       
Cough   10/212 (4.72%)  4/211 (1.90%)  6/211 (2.84%) 
Nasal congestion   9/212 (4.25%)  5/211 (2.37%)  3/211 (1.42%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Anna Novotney-Barry
Organization: Aviragen Therapeutics, Inc.
Phone: 678-221-3356
Responsible Party: Vaxart ( Biota Scientific Management Pty Ltd )
ClinicalTrials.gov Identifier: NCT01793883     History of Changes
Other Study ID Numbers: BTA51-350-201
HHSO100201100019C ( Other Grant/Funding Number: HHS BARDA )
2013-000582-36 ( EudraCT Number )
First Submitted: February 13, 2013
First Posted: February 18, 2013
Results First Submitted: July 31, 2017
Results First Posted: September 1, 2017
Last Update Posted: May 31, 2018