InfluenzaPhase 4SEA 004NCT00980109
Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir
A Phase 4 study testing active oseltamivir and zanamivir for inhalation in people with Influenza, run by University of Oxford at 2 sites in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- active oseltamivir and zanamivir for inhalation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Medicine Siriraj Hospital
Bangkok, Bangkoknoi, 10700
Hospital for Tropical Diseases
Bangkok, 10400
About this study
Official title: A Phase IV, Multi-center, Randomized, Partially Double Blinded, Placebo Controlled Study, to Evaluate the Safety of Daily Inhaled Zanamivir 10 mg Versus Placebo and Daily Oral Oseltamivir 75 mg Versus Placebo for Influenza Prophylaxis in Healthy Volunteers for 16 Weeks
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.
Read the 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)
- Conditions
- Influenza
- Being tested
- active oseltamivir, placebo capsule, zanamivir for inhalation, placebo for inhalation
- Keywords
- Influenza Prophylaxis, Long Term, Oral Oseltamivir, Inhaled Zanamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active oseltamivirDrug
Also called Tamiflu
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 capsuleDrug
Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day.
zanamivir for inhalationDrug
Also called Rotadisk/Diskhaler
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 inhalationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| placebo oseltamivir | Placebo comparator | Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day. Receives: Drug: placebo capsule |
| zanamivir for inhalation | Active comparator | 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. Receives: Drug: zanamivir for inhalation |
| placebo inhalation | Placebo comparator | 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. Receives: Drug: placebo for inhalation |
| active oseltamivir | Active comparator | 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. Receives: Drug: active oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who withdraw from the study because of serious adverse events (SAEs) that are possibly or probably or definitely related to the study drug
Measured: 1 year
Secondary outcomes (1)
Proportion of subjects who withdraw from the study because of SAEs unlikely or not related to study drug/placebo
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980109
- Sponsor's protocol ID
- SEA 004
- Other IDs
- N01AO50042
- Acronym
- SEA 004
- Status last verified
- Sep 2010
- First submitted
- 17 Sep 2009
- Last updated
- 22 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multi-center, Randomized, Partially Double Blinded, Placebo Controlled Study, to Evaluate the Safety of Daily Inhaled Zanamivir 10 mg Versus Placebo and Daily Oral Oseltamivir 75 mg Versus Placebo for Influenza Prophylaxis in Healthy Volunteers for 16 Weeks
- ClinicalTrials.gov ID
- NCT00980109
- Acronym / sponsor ID
- SEA 004 / SEA 004
- Conditions
- Influenza
- Keywords
- Influenza Prophylaxis, Long Term, Oral Oseltamivir, Inhaled Zanamivir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo oseltamivir | Placebo comparator | Drug: placebo capsulePlacebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day. |
| zanamivir for inhalation | Active comparator | Drug: zanamivir for inhalationZanamivir 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 comparator | Drug: placebo for inhalationPlacebo (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 | Active comparator | Drug: active oseltamivirOseltamivir 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Key exclusion criteria (18 listed)
- A subject will not be eligible for inclusion in this study if any of the following apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active oseltamivirAlso: TamifluOseltamivir 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. | Drug | active oseltamivir |
| placebo capsulePlacebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day. | Drug | placebo oseltamivir |
| zanamivir for inhalationAlso: Rotadisk/DiskhalerZanamivir 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. | Drug | zanamivir for inhalation |
| placebo for inhalationPlacebo (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. | Drug | placebo inhalation |
Primary outcome
Proportion of subjects who withdraw from the study because of serious adverse events (SAEs) that are possibly or probably or definitely related to the study drug
Time frame: 1 year
1 secondary outcome
Proportion of subjects who withdraw from the study because of SAEs unlikely or not related to study drug/placebo
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2010.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing active oseltamivir and zanamivir for inhalation in people with Influenza, run by University of Oxford at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who withdraw from the study because of serious adverse events (SAEs) that are possibly or probably or definitely related to the study drug (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2010.