Data

A randomised double-blind multi-site parallel arm controlled trial to assess relief of refractory breathlessness comparing fixed doses of morphine and placebo.

Palliative Care Clinical Studies Collaborative (PaCCSC)

Dataset description

Data set includes individual participant data for 299 consenting participants. A total of 284 participants were randomised (145 to Morphine, 139 to Placebo, and a further 74 participants to the oxycodone arm. The oxycodone arm was later dropped due to recruitment difficulties). The data sets includes CSV files for screening and baseline, day 1 and day 7 outcome data, and 4 weeks of follow-up. Data is available for clincial investigations, demographic information, Functional assessment (AKPS and DES), Dyspnoea descriptors, Breathlessness scores (VAS, Likert, and mMRC), EORTC QLQ-C15, and Respiratory Disease Questionnaire, Global Impression of Change, Carer Quality of Life, Life Space Assessment, Health Service Utilisation, Symptoms and Adverse Events.
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Source Study

Purpose

Treatment

Phase

Phase 3

Funding

Government body,Commonwealth Department of Health and Ageing

Scientific enquiries

Prof David Currow

Brief Summary

Breathlessness continues to be a major clinical problem for many people with advanced progressive illnesses such as chronic obstructive pulmonary disease, end-stage cardiac failure, and cancer, even when they are receiving the best treatment for their underlying disease. There are phase II/III data and one meta-analysis which support the use of morphine in this setting, but further good phase III data are needed in order to that this is a well tolerated and effective intervention suitable for a ....
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Key Inclusion Criteria

Adults (age >18) Refractory dyspnoea where the underlying cause of the dyspnoea has been maximally treated. Refractory dyspnoea does not have a minimum duration and can have been present for any period of time. A medical specialist must document that all identified reversible causes of the dyspnoea are being optimally managed. Breathlessness of a level 2 or higher on the modified MRC dyspnoea scale On stable medications over the prior week except routine “as needed” medications Prognosis of at l ....
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Key Exclusion Criteria

On regular opioid medications, including codeine preparations at or above the dose being studied in the previous 7 days. Anemia for which transfusion is not indicated within one month of baseline evaluation. Severely restricted performance status with Australian Karnofsky Performance score of <40 at baseline Uncontrolled nausea, vomiting and/or gastrointestinal obstruction. Renal dysfunction with creatinine clearance calculated as less than 25 mls/minute. Medical history of severe hepatic impair ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    238

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Refractory breathlessness.

Condition code    Respiratory

Intervention

Intervention code Treatment: Drugs

This is a phase III, multi-centre, randomised double-blind parallel arm controlled fixed dose trial studying treatment approaches for the relief of breathlessness in people with refractory dyspnoea. Participants will be randomised to identical-appearing sustained release morphine (20 mg every 24 hours (every morning), or placebo for one week. The intervention period will run for 7 days. At all times, all participants will have the ability to take up to eight doses of 2.5mg of immediate release o ....
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Comparison

Control group Placebo

Identical blinded placebo opaque capsule filled with cornstarch

Outcomes

Outcome: Change in the current sensation (intensity and unpleasantness) of breathlessness, measured using 100mm visual analogue dyspnoea scales and comparing outcomes by an average of morning and evening scores over the last three days of the study. A 15% improvement in breathlessness from baseline is considered a clinically meaningful improvement.
Timepoint: Average of morning and evening dyspnoea scores over last three days of the study.

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au