Pulmonary DiseasePhase 4AVTNCT02282384
An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.
A Phase 4 study testing oseltamivir in people with Pulmonary Disease and Influenza, run by McMaster University.
Trial summary
The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Disease, Influenza
- What is being tested?
- oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Mar 2015
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinic patients with physician diagnosed chronic obstructive pulmonary disease
- respirologist-diagnosed non-cystic fibrosis bronchiectasis and pulmonary fibrosis (based on appropriate clinical, exposure, and radiological criteria as per American Thoracic Society guidelines)
- Participants will be drawn from the respirology clinics and will be randomized if within 72 hours of meeting criteria for influenza-like illness
Who cannot join
- residents of nursing homes
- patients who are immunosuppressed
- patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer
About this study
Official title: A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.
- Conditions
- Pulmonary Disease, Influenza
- Being tested
- oseltamivir, Placebo
- Medical subject headings
- Lung Diseases, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oseltamivirDrug
Also called Tamiflu
They will be assessed for eligibility at the clinics and those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. Participants randomized to the control group will receive calcium carbonate placebo pills twice daily for five days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.
PlaceboOther
Also called Calcium Carbonate
| Study group | Role | What they receive |
|---|---|---|
| oseltamivir | Experimental | 75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset Receives: Drug: oseltamivir |
| Placebo | Placebo comparator | 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-elective admission to hospital
A non-elective admission to hospital, in contrast to visits to the emergency department where admission does not take place. However, a prolonged stay in the emergency department (> 24 hours) will also be considered to be hospitalization. Events that occur beyond this time period are deemed unlikely to be directly related to influenza,except functional status which will be assessed up to three months following acute respiratory infection. Secondly, the hospitalization must also be considered to be due to acute respiratory illness. An adjudication committee (comprised of two infectious diseases physicians who also practice general internal medicine) blinded to study group allocation will review data for hospitalization. They will be asked to judge whether the hospitalization was definitely or probably related to the acute respiratory illness. Those judged to be definitely or probably related will be considered as our primary outcome.
Measured: up to 28 days following randomization
Secondary outcomes (1)
lower respiratory tract infection
lower respiratory tract infection including exacerbation of chronic pulmonary disease
Measured: up to 28 days following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Sites were unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark B Loeb, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282384
- Sponsor's protocol ID
- AVT-2014
- Acronym
- AVT
- Status last verified
- Oct 2018
- First submitted
- 2 Sep 2014
- Last updated
- 26 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT02282384
- Acronym / sponsor ID
- AVT / AVT-2014
- Conditions
- Pulmonary Disease, Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sites were unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Nov 2014 (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.
The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oseltamivir | Experimental | Drug: oseltamivir75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset |
| Placebo | Placebo comparator | Other: Placebo75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinic patients with physician diagnosed chronic obstructive pulmonary disease
- respirologist-diagnosed non-cystic fibrosis bronchiectasis and pulmonary fibrosis (based on appropriate clinical, exposure, and radiological criteria as per American Thoracic Society guidelines)
- Participants will be drawn from the respirology clinics and will be randomized if within 72 hours of meeting criteria for influenza-like illness
Key exclusion criteria (3 listed)
- residents of nursing homes
- patients who are immunosuppressed
- patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer
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 |
|---|---|---|
| oseltamivirAlso: TamifluThey will be assessed for eligibility at the clinics and those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. Participants randomized to the control group will receive calcium carbonate placebo pills twice daily for five days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered. | Drug | oseltamivir |
| PlaceboAlso: Calcium Carbonate | Other | Placebo |
Primary outcome
non-elective admission to hospital
Time frame: up to 28 days following randomization
A non-elective admission to hospital, in contrast to visits to the emergency department where admission does not take place. However, a prolonged stay in the emergency department (> 24 hours) will also be considered to be hospitalization. Events that occur beyond this time period are deemed unlikely to be directly related to influenza,except functional status which will be assessed up to three months following acute respiratory infection. Secondly, the hospitalization must also be considered to be due to acute respiratory illness. An adjudication committee (comprised of two infectious diseases physicians who also practice general internal medicine) blinded to study group allocation will review data for hospitalization. They will be asked to judge whether the hospitalization was definitely or probably related to the acute respiratory illness. Those judged to be definitely or probably related will be considered as our primary outcome.
1 secondary outcome
lower respiratory tract infection
Time frame: up to 28 days following randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
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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.
Mark B Loeb, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oseltamivir in people with Pulmonary Disease and Influenza, run by McMaster University.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
non-elective admission to hospital (time frame: up to 28 days following randomization). 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 26 Oct 2018.