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

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.

Study Overview

• Status: Withdrawn
• Conditions: Influenza; Pulmonary Disease
• Intervention / Treatment: Other: Placebo; Drug: oseltamivir

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pneumonia		up to 28 days following randomization
neutrophilic bronchitis		up to 28 days following randomization
acute sinusitis		up to 28 days following randomization
antimicrobial prescriptions		up to 28 days following randomization
visits to medical providers	visits to emergency department without admission and non-routine visits to other physician clinics will be assessed separately	up to 28 days following randomization
changes in functional status	This outcome will be measured using Activities of Daily Living (ADL) score, an index of independence of activities of daily living. Will be assessed at baseline, 2 weeks, 1 month, 3 months after acute respiratory infection onset	up to 3 months from randomization
absenteeism from work		up to 28 days from randomization
additional care or support needed in the home	Need for new or additional informal caregiver support in the home, need for professional help in the home, transfer to a residential facility, need for rehabilitation for up to 3 months.	up to 3 months following randomization
laboratory testing using RT-PCR for influenza		up to 28 days following randomization

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Mark B Loeb, MD, McMaster University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Gastrointestinal Agents; Antacids; Calcium Carbonate; Oseltamivir
• Other Study ID Numbers: AVT-2014