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

Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease; Influenza

Intervention: oseltamivir (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: McMaster University

Official(s) and/or principal investigator(s):
Mark B Loeb, MD, Principal Investigator, Affiliation: McMaster University

Overall contact:
Sasha Eskandarian, MSc, Phone: 905-525-9140, Ext: 26672, Email: eskand@mcmaster.ca

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.

Clinical Details

Official title: A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: non-elective admission to hospital

Secondary outcome: lower respiratory tract infection

Detailed description: The pilot study will be a multi-centre, randomized, placebo controlled, pilot trial. If outpatients with chronic pulmonary disease at the Firestone Institute for Respiratory Health in Hamilton and at the respirology clinics of the Foothills Medical Centre in Calgary develop influenza-like illness when influenza is known to be continuously circulating, they will be assessed at the clinics and if they meet eligibility criteria will be randomized to oseltamivir or placebo and followed prospectively. We will test for influenza by RT-PCR however acute detection of influenza will not be a criterion for entry into the trial. The primary outcome for the eventual trial that we will also measure in this pilot is hospitalization Specifically, we will assess if ≥75% of participants can be randomized within 72 hours, if ≥ 90% of participants receive all doses of study medication, and if there is complete follow up in ≥95% of participants. If the pilot study meets our feasibility criteria, it will be deemed appropriate to plan for the larger trial, which we anticipate will require ~ 1,590 participants. If it appears that any of these will not met as we are conducting the trial, we will modify the protocol accordingly to ensure that they are.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Sasha Eskandarian, MSc, Phone: 905-525-9140, Ext: 26672, Email: eskand@mcmaster.ca

Foothills Medical Centre Respirology Clinic, Calgary, Alberta T2N 4W4, Canada; Not yet recruiting
Richard Leigh, MD, Phone: 403-210-8851, Email: rleigh@ucalgary.ca
Richard Leigh, MD, Sub-Investigator

Firestone Institute for Respiratory Health, Hamilton, Ontario L8N 1A6, Canada; Not yet recruiting
Stewart Pugsley, MD, Phone: 905-522-1155, Ext: 33491, Email: pugsleys@mcmaster.ca
Stewart Pugsley, MD, Sub-Investigator

Additional Information

Mark Loeb Research Group website

Related publications:

Langley JM, Faughnan ME. Prevention of influenza in the general population. CMAJ. 2004 Nov 9;171(10):1213-22. Review.

Schanzer DL, Langley JM, Tam TW. Co-morbidities associated with influenza-attributed mortality, 1994-2000, Canada. Vaccine. 2008 Aug 26;26(36):4697-703. doi: 10.1016/j.vaccine.2008.06.087. Epub 2008 Jul 11.

Blumentals WA, Schulman KL. Impact of oseltamivir on the incidence of secondary complications of influenza in adolescent and adult patients: results from a retrospective population-based study. Curr Med Res Opin. 2007 Dec;23(12):2961-70.

Burch J, Paulden M, Conti S, Stock C, Corbett M, Welton NJ, Ades AE, Sutton A, Cooper N, Elliot AJ, Nicholson K, Duffy S, McKenna C, Stewart L, Westwood M, Palmer S. Antiviral drugs for the treatment of influenza: a systematic review and economic evaluation. Health Technol Assess. 2009 Nov;13(58):1-265, iii-iv. doi: 10.3310/hta13580. Review.

Van Kerkhove MD, Vandemaele KA, Shinde V, Jaramillo-Gutierrez G, Koukounari A, Donnelly CA, Carlino LO, Owen R, Paterson B, Pelletier L, Vachon J, Gonzalez C, Hongjie Y, Zijian F, Chuang SK, Au A, Buda S, Krause G, Haas W, Bonmarin I, Taniguichi K, Nakajima K, Shobayashi T, Takayama Y, Sunagawa T, Heraud JM, Orelle A, Palacios E, van der Sande MA, Wielders CC, Hunt D, Cutter J, Lee VJ, Thomas J, Santa-Olalla P, Sierra-Moros MJ, Hanshaoworakul W, Ungchusak K, Pebody R, Jain S, Mounts AW; WHO Working Group for Risk Factors for Severe H1N1pdm Infection. Risk factors for severe outcomes following 2009 influenza A (H1N1) infection: a global pooled analysis. PLoS Med. 2011 Jul;8(7):e1001053. doi: 10.1371/journal.pmed.1001053. Epub 2011 Jul 5.

Starting date: October 2014
Last updated: October 31, 2014

Page last updated: August 23, 2015

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