Authors | Currow, D. Watts, G. J. Johnson, M. McDonald, C. F. Miners, J. O. Somogyi, A. A. Denehy, L. McCaffrey, N. Eckert, D. J. McCloud, P. Louw, S. Lam, L. Greene, A. Fazekas, B. Clark, K. C. Fong, K. Agar, M. R. Joshi, R. Kilbreath, S. Ferreira, D. Ekstrom, M. |
---|---|
Type | Protocol |
Journal | BMJ Open |
Year of Publication | 2017 |
URL | http://bmjopen.bmj.com/content/7/7/e018100 |
DOI | http://dx.doi.org/10.1136/bmjopen-2017-018100 |
Download | ![]() |
Abstract | Introduction Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD. Methods and analysis The primary question is what effect regular ER morphine has on worst breathlessness, measured daily on a 0-10 numerical rating scale. Uniquely, the coprimary outcome will use a FitBit to measure habitual physical activity. Secondary questions include safety and, whether upward titration after initial benefit delivers greater net symptom reduction. Substudies include longitudinal driving simulation, sleep, caregiver, health economic and pharmacogenetic studies. Seventeen centres will recruit 171 participants from respiratory and palliative care. The study has five phases including three randomisation phases to increasing doses of ER morphine. All participants will receive placebo or active laxatives as appropriate. Appropriate statistical analysis of primary and secondary outcomes will be used. Ethics and dissemination Ethics approval has been obtained. Results of the study will be submitted for publication in peer-reviewed journals, findings presented at relevant conferences and potentially used to inform registration of ER morphine for chronic breathlessness. Trial registration number NCT02720822; Pre-results. |
http://www.ibas.org.au/what-we-do/publications/3872938
Motor neurone disease (MND) causes the body's muscles to weaken. Breathing muscle weakness means that most people affected by MND will eventually lose the ability to take a deep breath and cough strongly....
RESPIRATORY BIOMARKERS IN MOTOR NEURONE DISEASE
The inability to breathe is unfortunately the most common cause of death in people living with Motor Neurone Disease (MND). Last year, our clinical research group in Melbourne reported that breathing...
Kudos to Dr. Lauren Booker & Dr. Jen Cori on their JOEM publication examining fatigue detection alarms in rural truck drivers. Their study explores the alarms' effectiveness, accuracy, and habituation, offering key insights into fatigue management.
HONORING EXCELLENCE IN RESEARCH
Congratulations to Prof. Anne Holland and A/Prof. Narelle Cox for being featured in the NHMRC's 10 of the Best - 16th Edition. Their work exemplifies groundbreaking research delivering extraordinary outcomes.
WORLD SLEEP DAY ON 14TH MARCH 2025
The benefits of quality sleep and to acknowledge the issue of sleep problems and their medical, educational, and social aspects as well as the prevention and management of sleep disorders, is promoted on World Sleep Day on the 14th March 2025.
Grants Success: The Institute for Breathing and Sleep (IBAS) has received two research grants from the Austin Medical Research Foundation (AMRF) for 2025. Congratulations to Dr Charissa Zaga and Dr Catherine Hill from IBAS.