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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 ch

Watts, Gareth J, Clark, Katherine, Agar, Meera, Davidson, Patricia M, McDonald, Christine, Lam, Lawrence T, Sajkov, Dimitar, McCaffrey, Nicola, Doogue, Matthew, Abernethy, Amy P, Currow, David C and Australian national Palliative Care Clinical Studies Collaborative 2016, 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, BMJ open, vol. 6, no. 11, pp. 1-12, doi: 10.1136/bmjopen-2016-013177.

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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
Author(s) Watts, Gareth J
Clark, Katherine
Agar, Meera
Davidson, Patricia M
McDonald, Christine
Lam, Lawrence T
Sajkov, Dimitar
McCaffrey, NicolaORCID iD for McCaffrey, Nicola orcid.org/0000-0003-3684-3723
Doogue, Matthew
Abernethy, Amy P
Currow, David C
Australian national Palliative Care Clinical Studies Collaborative
Journal name BMJ open
Volume number 6
Issue number 11
Article ID e013177
Start page 1
End page 12
Total pages 12
Publisher BMJ Group
Place of publication London, Eng.
Publication date 2016-11-01
ISSN 2044-6055
Summary 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.
Language eng
DOI 10.1136/bmjopen-2016-013177
Field of Research 110399 Clinical Sciences not elsewhere classified
Socio Economic Objective 929999 Health not elsewhere classified
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2016, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30093384

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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.