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

Phase 3

Completed

• Conditions: Refractory breathlessness.; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12609000806268
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 236

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 least 2 months in the opinion of the treating clinician
English-speaking and able to read study questionnaires (5th grade level)

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 impairment defined as ‘3 times upper limit of normal for 2 or more hepatic enzymes', or clotting via International Normalisation Ratio (INR) >1.2 – not treated with warfarin.
Evidence of respiratory depression with resting respiratory rate <8.
Active respiratory or cardiac event in the previous week, not including upper respiratory tract infections. Illness must have resolved completely prior to baseline evaluation, as judged by a doctor involved in the care of the person.
Documented previous respiratory failure induced by any opiate medication.
Unable to give informed consent or complete diary entries.
Pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Average of morning and evening dyspnoea scores over last three days of the study.]