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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01793883




Registration number
NCT01793883
Ethics application status
Date submitted
13/02/2013
Date registered
18/02/2013
Date last updated
31/05/2018

Titles & IDs
Public title
Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
Scientific title
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
Secondary ID [1] 0 0
HHSO100201100019C
Secondary ID [2] 0 0
BTA51-350-201
Universal Trial Number (UTN)
Trial acronym
Igloo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 40 mg Laninamivir Octanoate
Treatment: Drugs - 80 mg Laninamivir Octanoate
Treatment: Drugs - Placebo

Active Comparator: 40 mg Laninamivir Octanoate DPI - 40 mg Laninamivir Octanoate and matching placebo

Active Comparator: 80 mg Laninamivir Octanoate DPI - 80 mg Laninamivir

Placebo Comparator: Placebo - Matching Placebo


Treatment: Drugs: 40 mg Laninamivir Octanoate


Treatment: Drugs: 80 mg Laninamivir Octanoate


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Alleviation of Influenza Symptoms
Timepoint [1] 0 0
Efficacy will be assessed over 14 days post-randomization.

Eligibility
Key inclusion criteria
Main

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
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
639
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Dr Doong's Surgery - Burwood
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Hyde Park Medical - Sydney
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Westmead Hospital - Wentworthville
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Cairns Base Hospital - Cairns
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Jimboomba Junction Family Practice & Skin Cancer Clinic - Jimboomba
Recruitment hospital [6] 0 0
Mermaid Beach Medical Centre - Mermaid Beach
Recruitment hospital [7] 0 0
Morayfield 7 Day Medical Centre - Morayfield
Recruitment hospital [8] 0 0
AusTrials Pty Ltd. Sherwood - Sherwood
Recruitment hospital [9] 0 0
Pain & Anaesthesia Research Clinic - Adelaide
Recruitment hospital [10] 0 0
Hunter Clinical Research - Broadmeadows
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- Burwood
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- Sydney
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- Wentworthville
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- Cairns
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- Jimboomba
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- Mermaid Beach
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- Morayfield
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- Sherwood
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- Adelaide
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- Broadmeadows
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biota Scientific Management Pty Ltd
Address
Country
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Government body
Name [1] 0 0
Department of Health and Human Services
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01793883
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Lambert, PhD
Address 0 0
Biota Scientific Management Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01793883