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

NCT02282384 | Withdrawn Phase 4

• 1 other identifier: AVT-2014
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease; Influenza

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• lower respiratory tract infection

  up to 28 days following randomization

Other Outcomes (9)

• pneumonia

  up to 28 days following randomization

• neutrophilic bronchitis

  up to 28 days following randomization

• acute sinusitis

  up to 28 days following randomization

Study Arms (2)

oseltamivir

EXPERIMENTAL

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

Drug: oseltamivir

Placebo

PLACEBO COMPARATOR

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

Interventions

oseltamivir DRUG

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.

Also known as: Tamiflu

oseltamivir

Placebo OTHER

Also known as: Calcium Carbonate

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• residents of nursing homes
• patients who are immunosuppressed
• patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Lung Diseases; Influenza, Human

Interventions

Oseltamivir; Calcium Carbonate

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Mark B Loeb, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: November 4, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 26, 2018

Record last verified: 2018-10