Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.

      Randomisation Groups:

      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.

      Study duration

      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)
    

Intervention name(s): active oseltamivir; placebo capsule; zanamivir for inhalation; placebo for inhalation
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Tamiflu; Rotadisk/Diskhaler
Intervention MeSH terms: Oseltamivir; Zanamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza Prophylaxis; Long Term; Oral Oseltamivir; Inhaled Zanamivir