EUCTR2013-000582-36-FR进行中（未招募）1 期
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 and B Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 639
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 (ie, women who had a hysterectomy, had both ovaries surgically removed or have current documentation of tubal ligation, or are postmenopausal which is defined as 1 year without menses)
- •- 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. Highly effective method of birth control is one of the following:
- •Complete abstinence from intercourse from two weeks prior to Day 1 until 1 month after their last dose of study drug.
- •Implants of levonorgestrel
- •Injectable progesterone
- •Intrauterine device (IUD)
- •Oral contraceptives (either combined or progesterone only)
- •Double barrier method: condom, cervical cap or diaphragm with spermicidal agent
- •Transdermal contraceptive patch
- •Male partner who is sterile prior to the female subject’s entry into study and is the sole sexual partner for the female subject.
- •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.
- •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 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
- •c. =1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)
- •d. =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)
- •b. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion)
- •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 636
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •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. 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 self-administer laninamivir octanoate TwinCaps® DPI
研究者
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