Status:
COMPLETED
Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief 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 rela...
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...
Eligibility Criteria
Inclusion
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy male or female aged 20 - 65 years. Healthy determined by the Investigator based on medical history and screening examinations.
- Read and understand study related materials intended for subject.
- Signed informed consent prior to study participation.
- Willingness and ability to comply with the study protocol for the duration of the trial.
- 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).
- 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
- A subject will not be eligible for inclusion in this study if any of the following apply:
- Females who are pregnant, trying to get pregnant or are lactating.
- Current or a history of asthma or chronic obstructive pulmonary disease within the last 5 years.
- 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)
- Any other chronic or acute diseases requiring treatment.
- An abnormal ECG indicating disease that requires immediate investigation or treatment
- An abnormal chest x-ray indicating an active disease process.
- A creatinine clearance \< 30 mL/min as determined by Cockcroft-Gault equation (see below)
- AST or ALT ≥ 1.5 x ULN
- Use of a live attenuated influenza vaccine or any anti-influenza drug within 14 days prior to the first dose of study drugs/placebos.
- History of alcohol or substance abuse or dependence which in the opinion of the investigator would interfere with subject compliance or safety
- 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.
- The subject has participated in a clinical trial and has received investigational drugs within 60 days prior to the first dose of study drug.
- Subjects who, in the opinion of the investigator, are unlikely to comply fully with study procedures.
- History of any mental illness requiring hospitalisation or outpatient psychiatric treatment within the last 12 months
- Any suicidal attempt within the previous 5 years.
- Screening HADS anxiety or depression score \> 8.
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00980109
Start Date
September 1 2009
End Date
September 1 2010
Last Update
September 22 2010
Active Locations (2)
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1
Faculty of Medicine Siriraj Hospital
Bangkok, Bangkoknoi, Thailand, 10700
2
Hospital for Tropical Diseases
Bangkok, Thailand, 10400