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

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Pulmonary Disease Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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oseltamivir

75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset

Group Type EXPERIMENTAL

oseltamivir

Intervention Type DRUG

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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oseltamivir

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.

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Tamiflu Calcium Carbonate

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No