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 Infectio
- Conditions
- Treatment of influenza caused by viruses type A and BMedDRA version: 16.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862MedDRA version: 16.1Level: LLTClassification code 10022003Term: Influenza B virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-000582-36-HU
- Lead Sponsor
- Biota Scientific Management Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
1. Provide written informed consent
2. Males or females aged 18–64 years, inclusive
3. A female subject is eligible to enter the study if she meets following criteria:
- not pregnant or breast feeding / lactating
- females of non-childbearing potential
- females of child bearing potential must have a negative urine pregnancy test at screening
- females of childbearing potential must agree to use adequate and highly effective methods of contraception throughout the study. (See Section 4.5)
4. Male subjects with female partners of childbearing potential must use adequate and highly effective methods of contraception such as double barrier method, from screening until 1 month after their last dose of study drug. (See Section 4.5)
5. Symptomatic presumptive influenza A or B infection defined as the presence of:
a. a fever of =38.0 ºC (=100.4 ºF) at the screening visit
AND
b. =1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)
AND
c. =1 moderate respiratory symptom (cough, sore throat and nasal congestion)
6. 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:
a. time when the subjects' temperature was measured as elevated (=
38.0 °C (=100.4 ºF)
OR
b. time when the subject first experienced at least one respiratory
symptom (cough, sore throat and nasal congestion)
OR
c. time when the subject first experienced at least one systemic
symptom (headache, feeling feverish, body aches and pains, and
fatigue)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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 within 30 days proir screening
6. Presence of clinically significant signs of acute respiratory distress during screening
7. Current use of inhaled medications (nasal or oral) or anticipated use
8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known calculated creatinine clearance (CLCR) of <60 mL/min
9. Presence of clinically significant abnormalities on ECG at screening which, in the investigator's clinical judgment, may affect either the subject's ability to participate in the study or the study results
10. 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
11. Currently hospitalized or any planned hospitalizations within 1 month following the last dose of study drug
12. Current clinical evidence of otitis, bronchitis, sinusitis, pneumonia or active bacterial infection at any body site, that requires treatment with oral or parenteral antibiotics
13. Documented or reported (known) history of hepatitis B, hepatitis C, TB or HIV infection
14. Severe infection within 30 days prior to screening which required parenteral antibiotic use or hospitalization
15. History of or known clinically significant liver disease
16. History of, or current evidence of, abuse (in the investigator's opinion) of alcohol or any licit or illicit drug substance within the past 12 months
17. History of adverse reaction or known hypersensitivity to lactose or neuraminidase inhibitors
18. Received an investigational drug within 30 days prior to screening
19. Subjects who in the opinion of the investigator are unable to independently complete study documentation e.g. Flu-iiQ™ or selfadminister laninamivir octanoate TwinCaps® DPI
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method