Trial record 2 of 10 for:    biota

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biota Scientific Management Pty Ltd
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier:
NCT01793883
First received: February 13, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Drug: 40 mg Laninamivir Octanoate
Drug: 80 mg Laninamivir Octanoate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Biota Scientific Management Pty Ltd:

Primary Outcome Measures:
  • Time to alleviation of influenza symptoms [ Time Frame: Efficacy will be assessed over 14 days post-randomization. ] [ Designated as safety issue: No ]
    Time to alleviation of influenza will be assessed through study questionnaires and diary cards from Day 1 to 14.


Estimated Enrollment: 636
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 40 mg Laninamivir Octanoate DPI
40 mg Laninamivir Octanoate and matching placebo
Drug: 40 mg Laninamivir Octanoate
Other Name: CS-8958
Drug: Placebo
Other Name: Lactose
Active Comparator: 80 mg Laninamivir Octanoate DPI
80 mg Laninamivir
Drug: 80 mg Laninamivir Octanoate
Other Name: CS-8958
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Other Name: Lactose

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793883

Contacts
Contact: Annette Leahy +61 3 99153700 a.leahy@biota.com.au

  Show 221 Study Locations
Sponsors and Collaborators
Biota Scientific Management Pty Ltd
Investigators
Study Director: John Lambert, PhD Biota Scientific Management Pty Ltd
  More Information

No publications provided

Responsible Party: Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier: NCT01793883     History of Changes
Other Study ID Numbers: BTA51-350-201, HHSO100201100019C, 2013-000582-36
Study First Received: February 13, 2013
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biota Scientific Management Pty Ltd:
Influenza Laninamivir Octanoate

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014