Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/16986
Title: Study protocol: a phase III randomised, double-blind, parallel arm, stratified, block randomised, placebo-controlled trial investigating the clinical effect and cost-effectiveness of sertraline for the palliative relief of breathlessness in people with chronic breathlessness
Authors: Watts, Gareth J;Clark, Katherine;Agar, Meera;Davidson, Patricia M;McDonald, Christine F;Lam, Lawrence T;Sajkov, Dimitar;McCaffrey, Nicola;Doogue, Matthew;Abernethy, Amy P;Currow, David C;Australian national Palliative Care Clinical Studies Collaborative (PaCCSC)
Issue Date: 29-Nov-2016
Citation: BMJ Open 2016; 6(11): e013177
Abstract: INTRODUCTION: Breathlessness remains a highly prevalent and distressing symptom for many patients with progressive life-limiting illnesses. Evidence-based interventions for chronic breathlessness are limited, and there is an ongoing need for high-quality research into developing management strategies for optimal palliation of this complex symptom. Previous studies have suggested that selective serotonin reuptake inhibitors such as sertraline may have a role in reducing breathlessness. This paper presents the protocol for a large, adequately powered randomised study evaluating the use of sertraline for chronic breathlessness in people with progressive life-limiting illnesses. METHODS AND ANALYSIS: A total of 240 participants with modified Medical Research Council Dyspnoea Scale breathlessness of level 2 or higher will be randomised to receive either sertraline or placebo for 28 days in this multisite, double-blind study. The dose will be titrated up every 3 days to a maximum of 100 mg daily. The primary outcome will be to compare the efficacy of sertraline with placebo in relieving the intensity of worst breathlessness as assessed by a 0-100 mm Visual Analogue Scale. A number of other outcome measures and descriptors of breathlessness as well as caregiver assessments will also be recorded to ensure adequate analysis of participant breathlessness and to allow an economic analysis to be performed. Participants will also be given the option of continuing blinded treatment until either study data collection is complete or net benefit ceases. Appropriate statistical analysis of primary and secondary outcomes will be used to describe the wealth of data obtained. ETHICS AND DISSEMINATION: Ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12610000464066.
URI: http://ahro.austin.org.au/austinjspui/handle/1/16986
DOI: 10.1136/bmjopen-2016-013177
PubMed URL: https://www.ncbi.nlm.nih.gov/pubmed/27899400
Type: Journal Article
Subjects: PALLIATIVE CARE
breathlessness
protocol
randomised control trial
sertraline
Appears in Collections:Journal articles

Files in This Item:
There are no files associated with this item.


Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.