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

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ClinicalTrials.gov Identifier: NCT02282384
Recruitment Status : Withdrawn (Sites were unable to recruit participants)
First Posted : November 4, 2014
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease Influenza Drug: oseltamivir Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
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 Name: Tamiflu

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 Name: Calcium Carbonate




Primary Outcome Measures :
  1. non-elective admission to hospital [ Time Frame: 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 :
  1. lower respiratory tract infection [ Time Frame: up to 28 days following randomization ]
    lower respiratory tract infection including exacerbation of chronic pulmonary disease


Other Outcome Measures:
  1. pneumonia [ Time Frame: up to 28 days following randomization ]
  2. neutrophilic bronchitis [ Time Frame: up to 28 days following randomization ]
  3. acute sinusitis [ Time Frame: up to 28 days following randomization ]
  4. antimicrobial prescriptions [ Time Frame: up to 28 days following randomization ]
  5. visits to medical providers [ Time Frame: up to 28 days following randomization ]
    visits to emergency department without admission and non-routine visits to other physician clinics will be assessed separately

  6. changes in functional status [ Time Frame: up to 3 months from randomization ]
    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

  7. absenteeism from work [ Time Frame: up to 28 days from randomization ]
  8. additional care or support needed in the home [ Time Frame: up to 3 months following randomization ]
    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.

  9. laboratory testing using RT-PCR for influenza [ Time Frame: up to 28 days following randomization ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282384


Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Mark B Loeb, MD McMaster University

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02282384     History of Changes
Other Study ID Numbers: AVT-2014
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Oseltamivir
Calcium Carbonate
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Gastrointestinal Agents