A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study

AuthorsCurrow, 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.
TypeProtocol
JournalBMJ Open
Year of Publication2017
URLhttp://bmjopen.bmj.com/content/7/7/e018100
DOIhttp://dx.doi.org/10.1136/bmjopen-2017-018100
Download e018100full_.pdf (347.6 KB)
AbstractIntroduction 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


< More publications



SHiQ - COSAQSHIQ - COSAQ

Each year in Australia 260 people sustain a SCI, with over half losing full function in their arms and legs (quadriplegia). In addition to the primary disability, there is a very high rate of Obstructive...

Notch monitoring in sleepNOTCH MONITORING IN SLEEP

Sleep apnea is a condition where breathing is abnormal during sleep. There are two main forms of sleep apnea: obstructive and central. For obstructive sleep apnea, breathing is reduced because the airway...

IBAS Director Anna Burke unveiling of her portrait at Canberra's Parliament HouseIBAS DIRECTOR ANNA BURKE UNVEILING OF HER PORTRAIT AT CANBERRA'S PARLIAMENT HOUSE

Anna Burke had barely got into the swing of her speech at the unveiling of her portrait at Canberra's Parliament House when the ringing of bells caused half her audience to hurry away

Thunderstorm asthma expected to return in 2017THUNDERSTORM ASTHMA EXPECTED TO RETURN IN 2017

The Morning Show - Thunderstorm asthma expected to return in 2017. The Daily Edition - Thunderstorm Asthma is an unexpected killer. Better Health Channel - Thunderstorm asthma explained. Professor Christine McDonald

National study offers hope for breathlessnessNATIONAL STUDY OFFERS HOPE FOR BREATHLESSNESS

A national medication study is aiming to help thousands of Australians who struggle every day with shortness of breath

Helping Victorians breathe and sleep easy - A New Centre of Excellence in Respiratory and Sleep MedicineHELPING VICTORIANS BREATHE AND SLEEP EASY - A NEW CENTRE OF EXCELLENCE IN RESPIRATORY AND SLEEP MEDICINE

With your support we will build a life-changing Centre of Excellence in Respiratory and Sleep Medicine, improving quality of life and health outcomes for Victorians who struggle to breathe and sleep

Institute for Breathing and Sleep

Level 5, Harold Stokes Building, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084

(03) 9496 5390

Email Us

Donate