Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir
NCT ID: NCT00980109
Last Updated: 2010-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
390 participants
INTERVENTIONAL
2009-09-30
2010-09-30
Brief Summary
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It is hypothesized that oseltamivir and zanamivir will protect participants from becoming infected with influenza.
Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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placebo oseltamivir
Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day.
placebo capsule
Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day.
zanamivir for inhalation
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.
zanamivir for inhalation
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 inhalation
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.
placebo for inhalation
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.
active oseltamivir
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.
active oseltamivir
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.
Interventions
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active oseltamivir
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 capsule
Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day.
zanamivir for inhalation
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 for inhalation
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 Names
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Eligibility Criteria
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Inclusion Criteria
1. Healthy male or female aged 20 - 65 years. Healthy determined by the Investigator based on medical history and screening examinations.
2. Read and understand study related materials intended for subject.
3. Signed informed consent prior to study participation.
4. Willingness and ability to comply with the study protocol for the duration of the trial.
5. Female subject who is of reproductive potential agrees to use an acceptable method of birth control (e.g., intrauterine device, abstinence or hormonal contraceptive drug) throughout the study (D120+2).
6. For male subject, he must agree to use an acceptable method of birth control (e.g. abstinence or condom) throughout the study (D120+2).
Exclusion Criteria
1. Females who are pregnant, trying to get pregnant or are lactating.
2. Current or a history of asthma or chronic obstructive pulmonary disease within the last 5 years.
3. Abnormal pulmonary function test according to The Thoracic Society of Thailand Guidelines for Pulmonary Function Tests: (i) FVC \< 80% of the predicted value for age and sex or (ii) FEV1/FVC \<70%. (see Appendix 2)
4. Any other chronic or acute diseases requiring treatment.
5. An abnormal ECG indicating disease that requires immediate investigation or treatment
6. An abnormal chest x-ray indicating an active disease process.
7. A creatinine clearance \< 30 mL/min as determined by Cockcroft-Gault equation (see below)
8. AST or ALT ≥ 1.5 x ULN
9. Use of a live attenuated influenza vaccine or any anti-influenza drug within 14 days prior to the first dose of study drugs/placebos.
10. History of alcohol or substance abuse or dependence which in the opinion of the investigator would interfere with subject compliance or safety
11. Subjects who have a history of allergy to the study drug or drugs of the same class, or a history of severe drug (e.g. toxic epidermal necrolysis) or other allergy (e.g. previous history of anaphylaxis) that, in the opinion of the investigator, contraindicates participation in the trial.
12. The subject has participated in a clinical trial and has received investigational drugs within 60 days prior to the first dose of study drug.
13. Subjects who, in the opinion of the investigator, are unlikely to comply fully with study procedures.
14. History of any mental illness requiring hospitalisation or outpatient psychiatric treatment within the last 12 months
15. Any suicidal attempt within the previous 5 years.
16. Screening HADS anxiety or depression score \> 8.
17. Hemoglobin \<11g/dL or neutropenia of \< 1000 per microlitre or a platelet count of less than 100,000 cells/mm3 Cockroft formula: CrCl (mL/min) = (140 - age) x Wt / 72 x serum creatinine (females x 0.85), age in years, Wt in kg, serum creatinine in mg/dL.
20 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Oxford
OTHER
Responsible Party
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Masters and Scholars of the University of Oxford
Locations
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Faculty of Medicine Siriraj Hospital
Bangkok, Bangkoknoi, Thailand
Hospital for Tropical Diseases
Bangkok, , Thailand
Countries
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Other Identifiers
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SEA 004
Identifier Type: -
Identifier Source: org_study_id