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

Phase 4

Withdrawn

• Conditions: Pulmonary Disease; Influenza
• Interventions: Drug: oseltamivir; Other: Placebo

• Registration Number: NCT02282384
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-02
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oseltamivir	oseltamivir	75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
Placebo	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

Primary Outcome Measures

Name	Time	Method
non-elective admission to hospital	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.

Secondary Outcome Measures

Name	Time	Method
lower respiratory tract infection	up to 28 days following randomization	lower respiratory tract infection including exacerbation of chronic pulmonary disease