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Grant: Project Grant

Research Institute of the McGill University Health Centre

$187,425.00

Sublingual Fentanyl for acute relief of breathlessness in patients with advanced COPD : A randomized double-blind, placebo-controlled, crossover design trial.

EF 2019-20

Résumé
According to Health Canada, Chronic Obstructive Pulmonary Disease (COPD) affects over 2 millions of Canadian adults and,with an ageing population , the prevalence of the disease has increased. Breathlessness is the main manifestation of COPD and is often an invalidating symptom for patients with severe disease despite being on optimal inhaled treatment. In fact, the presence of dyspnea is recognized as a major determinant of health-related quality of life and it often leads to unplanned hospitalizations, which result in significant cost on the healthcare system. Breakthrough COPD dyspnea represents an important element in the spectrum of managing breathlessness in COPD patients. Breakthrough COPD dyspnea are acute episodes of breathlessness that could peak in intensity within a few minutes and for which the speed of medication onset is crucial for proper control beyond the use of existing short acting inhaled therapy. Recently, oral morphine was demonstrated as an effective and safe option for the control of refractory breathlessness and is now recommended by clinical guidelines in this context. However, this approach might not always offer optimal onset of action to match the rapid nature of an episode of breakthrough COPD dyspnea. Novel approach that includes the use of small dose sublingual liquid fentanyl might be more effective while remaining safe to treat breakthrough COPD dyspnea. This approach has been shown to be effective for pain control but it has never been tested to treat breakthrough COPD dyspnea. We propose a multicenter randomized trial to evaluate the effect of sublingual fentanyl on breathlessness control in severe to very-severe COPD patients with persistent shortness of breath despite optimal therapy. This study is a crucial step toward appropriate treatment selection for breakthrough COPD dyspnea and it will also pave the way to future research for control of acute refractory breathlessness in other severe respiratory diseases.
Programme
Project Grant
Emplacement
Quebec, Canada
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
419718
Name
Bourbeau Jean
Region
Québec
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Respiratory System
Projecttitle
Sublingual Fentanyl for acute relief of breathlessness in patients with advanced COPD : A randomized double-blind, placebo-controlled, crossover design trial.
Programtype2
Operating Grants
Orgnameinp2
Research Institute of the McGill University Health Centre
Cihramount2
$187,425
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Breathlessness; Copd; Dyspnea; Opioid; Pharmacotherapy; Sublingual Fentanyl
Abstract
According to Health Canada, Chronic Obstructive Pulmonary Disease (COPD) affects over 2 millions of Canadian adults and,with an ageing population , the prevalence of the disease has increased. Breathlessness is the main manifestation of COPD and is often an invalidating symptom for patients with severe disease despite being on optimal inhaled treatment. In fact, the presence of dyspnea is recognized as a major determinant of health-related quality of life and it often leads to unplanned hospitalizations, which result in significant cost on the healthcare system. Breakthrough COPD dyspnea represents an important element in the spectrum of managing breathlessness in COPD patients. Breakthrough COPD dyspnea are acute episodes of breathlessness that could peak in intensity within a few minutes and for which the speed of medication onset is crucial for proper control beyond the use of existing short acting inhaled therapy. Recently, oral morphine was demonstrated as an effective and safe option for the control of refractory breathlessness and is now recommended by clinical guidelines in this context. However, this approach might not always offer optimal onset of action to match the rapid nature of an episode of breakthrough COPD dyspnea. Novel approach that includes the use of small dose sublingual liquid fentanyl might be more effective while remaining safe to treat breakthrough COPD dyspnea. This approach has been shown to be effective for pain control but it has never been tested to treat breakthrough COPD dyspnea. We propose a multicenter randomized trial to evaluate the effect of sublingual fentanyl on breathlessness control in severe to very-severe COPD patients with persistent shortness of breath despite optimal therapy. This study is a crucial step toward appropriate treatment selection for breakthrough COPD dyspnea and it will also pave the way to future research for control of acute refractory breathlessness in other severe respiratory diseases.
Competitiondate
202003
Approvedterm2
2 yrs 0 mth
Pinamesdelim
Bourbeau, Jean; Gagnon, Sébastien
Approvedterm
2 ans 0 mois
Cihrcontribution2
~ $187,425~ $0~