An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study

Conditions
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Influenza, Pulmonary Disease

Intervention / Treatment
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* Drug: oseltamivir
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: residents of nursing homes patients who are immunosuppressed patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oseltamivir<br>75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset | Drug: oseltamivir<br>* 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.<br>* Other names: Tamiflu;|
| Placebo Comparator: Placebo<br>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 | Other: Placebo<br> <br> * Other names: Calcium Carbonate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 28 days following randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower respiratory tract infection | lower respiratory tract infection including exacerbation of chronic pulmonary disease | up to 28 days following randomization |