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

McMaster University

Status and phase: Withdrawn; Phase 4

Conditions: Influenza; Pulmonary Disease

Treatments: Other: Placebo; Drug: oseltamivir

Study type: Interventional

Funder types: Other

Identifiers

NCT02282384

AVT-2014

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

oseltamivir

Experimental group

Description:

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

Treatment:

Drug: oseltamivir

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo