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This is a multicenter, randomised, four arms placebo controlled study to evaluate the safety and tolerability of 10 mg inhaled zanamivir once a day and 75 mg oseltamivir capsule orally once a day relative to placebo over 16 weeks (112 days). Enrolled subjects will be randomly assigned to 2:1:2:1 ratio (active oseltamivir: placebo: active zanamivir: placebo) on one of the four study treatment groups.
It is hypothesized that oseltamivir and zanamivir will protect participants from becoming infected with influenza.
We plan to recruit 130 non-pregnant subjects including Health Care Workers, which refer to anyone who works in the hospital, into each active arm and 65 healthy, non-pregnant subjects including Health Care Workers into each placebo arm for a total of 390 study subjects from 4 study sites in Bangkok and Nonthaburi province, Thailand: (i) Faculty of Medicine Siriraj Hospital, (ii) Bamrasnaradura Infectious Diseases Institute, (iii) Chest Disease Institute, and (iv) Hospital for Tropical Diseases.
Zanamivir for inhalation, (5 mg per inhalation), two inhalations, once daily using a ROTADISK/DISKHALER for 112 days. The dose should be administered at approximately the same time each day.
Placebo (lactose powder), two inhalations, once daily using a ROTADISK/ DISKHALER for 112 days. The dose should be administered at approximately the same time each day.
Oseltamivir capsules (75 mg per capsule), one capsule daily by mouth (PO) for 112 days. The dose should be administered at approximately the same time each day.
Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day.
The study is expected to last up to about 12 months. The study will consist of:
- a screening visit
- 10 study visits: Days 0 , 7 (+2), 14 (+2), 28 (+2), 42 (+2), 56 (+2), 70 (+2), 84 (+2), 98 (+2) and 112 (+2) and
- One follow-up visit on Day 120 (+2)
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
active oseltamivir, placebo capsule, zanamivir for inhalation, placebo for inhalation
Faculty of Medicine Siriraj Hospital
University of Oxford
Published on BioPortfolio: 2014-08-27T03:19:13-0400
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