An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study. (AVT)
Primary Purpose
Pulmonary Disease, Influenza
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
oseltamivir
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oseltamivir
Placebo
Arm Description
75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
lower respiratory tract infection
lower respiratory tract infection including exacerbation of chronic pulmonary disease
Full Information
NCT ID
NCT02282384
First Posted
September 2, 2014
Last Updated
October 25, 2018
Sponsor
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT02282384
Brief Title
An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.
Acronym
AVT
Official Title
A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Sites were unable to recruit participants
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oseltamivir
Arm Type
Experimental
Arm Description
75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
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
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcium Carbonate
Primary Outcome Measure Information:
Title
non-elective admission to hospital
Description
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.
Time Frame
up to 28 days following randomization
Secondary Outcome Measure Information:
Title
lower respiratory tract infection
Description
lower respiratory tract infection including exacerbation of chronic pulmonary disease
Time Frame
up to 28 days following randomization
Other Pre-specified Outcome Measures:
Title
pneumonia
Time Frame
up to 28 days following randomization
Title
neutrophilic bronchitis
Time Frame
up to 28 days following randomization
Title
acute sinusitis
Time Frame
up to 28 days following randomization
Title
antimicrobial prescriptions
Time Frame
up to 28 days following randomization
Title
visits to medical providers
Description
visits to emergency department without admission and non-routine visits to other physician clinics will be assessed separately
Time Frame
up to 28 days following randomization
Title
changes in functional status
Description
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
Time Frame
up to 3 months from randomization
Title
absenteeism from work
Time Frame
up to 28 days from randomization
Title
additional care or support needed in the home
Description
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.
Time Frame
up to 3 months following randomization
Title
laboratory testing using RT-PCR for influenza
Time Frame
up to 28 days following randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark B Loeb, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.
We'll reach out to this number within 24 hrs