Breathlessness Exertion and Morphine Sulphate

Summary

Breathlessness is an overwhelming symptom affecting tens of thousands of Australians every day. For many people, it persists even when all the underlying causes have been optimally managed (chronic breathlessness). In these circumstances, it often occurs at rest or with minimal exertion.

Evidence from a number of clinical studies suggests that a small, regular dose of morphine helps to reduce safely the sensation of breathlessness. However, it is not well established which patients derive more benefit and what is the net clinical effect of this treatment (weighing benefits and harms).

This is a phase III, multi-site, randomised, double-blind, placebo-controlled trial with patients with chronic obstructive pulmonary disease (COPD) and severe chronic breathlessness which will explore several important questions:

* Are regular, low doses of morphine at four possible doses over 3 weeks more effective than placebo at improving breathlessness?
* Does increasing the dose in people who already are experiencing some benefit provide even greater reduction in worst breathlessness?
* Does the medication have any effect on daily activity and quality of life?
* What are the common or serious side effects of this intervention?
* Does the benefit from the medication outweigh the side effects it produces?
* Are there specific characteristics of people who are more likely to receive benefit from extended release morphine?

Participants will receive once daily extended release morphine (plus laxative, docusate with senna), or placebo (placebo laxative) in addition to their usual medication for up to 3 weeks at increasing doses.

Participants will have a medical interview and physical examination to collect some general health information, and baseline measurements including; daily activity, symptoms, and quality of life. A small amount of blood may be required to check eligibility. Further blood samples may be taken at week 1 and 3 to enable testing on how individuals respond to opioids, further consent will be obtained for these samples.

Data on benefits, side effects, and medical care will be collected during comprehensive weekly visits. Participants will also fill out a simple diary twice daily for weeks one to three of the study, and for one day each week during an optional 6 month extension stage.

The outcome of this study may enable better management of symptoms and activity in people COPD with medicines that are shown to be effective and safe.

Conditions

• Chronic Obstructive Pulmonary Disease
• Dyspnea

Interventions

DRUG

Placebo

Treatment with placebo is given as one double-blind capsule in the morning.

DRUG

Morphine Sulfate

Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.

DRUG

Plus laxative (Docusate with senna)

If patients are taking morphine, a laxative will be offered. This applies whatever the dose of morphine being taken (8mg, 16mg, 24mg or 32 mg).

DRUG

Plus placebo laxative

If the patients are taking placebo, a placebo laxative will be offered.

DEVICE

FitBit charge HR (Accelerometer)

A Fitbit will be worn by patients during week 1 and week 3.

Sponsors & Collaborators

• Flinders University

  lead OTHER

Principal Investigators

• David C Currow, MD, PhD · Study Principal Investigator; Flinders University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-08

Primary Completion

2019-12-20

Completion

2019-12-20

Countries

• Australia
• New Zealand

Study Locations