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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02720822
Registration number
NCT02720822
Ethics application status
Date submitted
10/03/2016
Date registered
28/03/2016
Date last updated
11/02/2020
Titles & IDs
Public title
Breathlessness Exertion and Morphine Sulphate
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Scientific title
A Pragmatic, Phase III, Multi-site, Double-blind, Placebo Controlled, Parallel Arm, Dose Increment Randomised Trial of Regular, Low Dose Extended Release Morphine for Chronic Refractory Breathlessness
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Secondary ID [1]
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030/15
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Universal Trial Number (UTN)
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Trial acronym
BEAMS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Dyspnea
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Morphine Sulfate
Treatment: Drugs - Plus laxative (Docusate with senna)
Treatment: Drugs - Plus placebo laxative
Treatment: Devices - FitBit charge HR (Accelerometer)
Placebo Comparator: Placebo - Double-blind placebo capsule, looking identical to capsules with active treatment, during all three treatment weeks.
Experimental: Morphine Sulfate (0, 0, 8 mg) - Placebo on weeks one and two. Morphine 8 mg/day on week three.
Experimental: Morphine sulfate (0, 8, 8 mg) - Placebo on week one. Morphine 8 mg/day on weeks two and three.
Experimental: Morphine sulfate (0, 8, 16 mg) - Placebo on week one. Morphine 8 mg/day on week two. Morphine 16 mg/day on week three.
Experimental: Morphine sulfate (8, 8, 8 mg) - Morphine 8 mg/day on weeks one, two and three.
Experimental: Morphine sulfate (8, 8, 16 mg) - Morphine 8 mg/day on weeks one and two. Morphine 16 mg/day on week three.
Experimental: Morphine sulfate (8, 16, 16 mg) - Morphine 8 mg/day on week one. Morphine 16 mg/day on weeks two and three.
Experimental: Morphine sulfate (8, 16, 24 mg) - Morphine 8 mg/day on week one. Morphine 16 mg/day on week two. Morphine 24 mg/day on week three.
Experimental: Morphine sulfate (16, 16, 16 mg) - Morphine 16 mg/day on weeks one, two and three.
Experimental: Morphine sulfate (16, 16, 24 mg) - Morphine 16 mg/day on weeks one and two. Morphine 24 mg/day on week three.
Experimental: Morphine sulfate (16, 24, 24 mg) - Morphine 16 mg/day on week one. Morphine 24 mg/day on weeks two and three.
Experimental: Morphine sulfate (16, 24, 32 mg) - Morphine 16 mg/day on week one. Morphine 24 mg/day on week two. Morphine 32 mg/day on week three.
Treatment: Drugs: Placebo
Treatment with placebo is given as one double-blind capsule in the morning.
Treatment: Drugs: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Treatment: Drugs: 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).
Treatment: Drugs: Plus placebo laxative
If the patients are taking placebo, a placebo laxative will be offered.
Treatment: Devices: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline worst breathlessness intensity over the previous 24 hours
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Assessment method [1]
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Rated on a 0-10 numerical rating scale (NRS). Measured at baseline, Stage1-3 (daily diary) and Stage 4 (weekly diary). The primary endpoint is:
The difference between morphine sulphate 8mg and placebo (end of week1)
The difference of morphine sulphate 16 mg and placebo (end of week 1)
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Timepoint [1]
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Week 1
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Primary outcome [2]
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Change from the baseline in the number of steps per day
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Assessment method [2]
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Difference from the baseline in the number of steps per day measured using the Fitbit(Charge HR). Measured at baseline, end of week 1, and end of week 3. The primary endpoint is:
The difference between morphine sulphate 8mg and placebo (end of week 1)
The difference between morphine sulphate 16mg and placebo (end of week 1)
Comparison between baseline and end of week 3
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Timepoint [2]
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Week 3
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Secondary outcome [1]
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Change from baseline end-tidal carbon dioxide
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Assessment method [1]
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Measured at baseline and at the weekly visit for the randomisation phase, and then at the study exit in order to assess the theoretical risk of opioids worsening respiratory failure. Stages 1-4.
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Timepoint [1]
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Up to week 15
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Secondary outcome [2]
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Change from baseline pulse oximetry
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Assessment method [2]
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Measured at baseline and at the weekly visit for the randomisation phase, and then at the study exit in order to assess the theoretical risk of opioids worsening respiratory failure. Concomitant use of oxygen will be recorded. Stages 1-4.
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Timepoint [2]
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Up to week 15
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Secondary outcome [3]
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Change from baseline intensity of breathlessness "average"
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Assessment method [3]
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Rated on a 0-10 numerical rating scale (NRS). Measured at baseline, weeks 1-3 (daily diary) and stage 4 (weekly diary).
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Timepoint [3]
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Up to week 15
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Secondary outcome [4]
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Change from baseline distress from breathlessness over the previous 24 hours
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Assessment method [4]
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Rated on a 0-10 numerical rating scale (NRS). Measured at baseline, weeks 1-3 (daily diary) and stage 4 (weekly diary).
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Timepoint [4]
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Up to week 15
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Secondary outcome [5]
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Change from baseline perceived-impact of breathlessness
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Assessment method [5]
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Chronic Respiratory Questionnaire - Dyspnoea and Mastery Subscales. Baseline and end of Weeks 1-3.
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Timepoint [5]
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Up to week 3
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Secondary outcome [6]
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Change from baseline functional impact of breathlessness
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Assessment method [6]
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Rated on the Modified Medical Research Council Breathlessness Scale (mMRC). Measured at baseline and at the conclusion of the study.
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Timepoint [6]
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Up to week 15
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Secondary outcome [7]
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Change from baseline sleep minutes
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Assessment method [7]
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Measured using the Fitbit(Charge HR). Assessed at baseline (2 days), weeks 1 and 3.
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Timepoint [7]
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Week 3
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Secondary outcome [8]
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Change from baseline sleep activity
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Assessment method [8]
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Measured using the Fitbit(Charge HR). Given in number of movements per night (e.g. rolling over). Assessed at baseline (2 days), weeks 1 and 3.
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Timepoint [8]
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Week 3
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Secondary outcome [9]
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Change from baseline in activity levels
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Assessment method [9]
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Measured using the Fitbit(Charge HR). Difference from baseline in the number of active minutes per day. Assessed at baseline (2 days), weeks 1 and 3.
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Timepoint [9]
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Week 3
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Secondary outcome [10]
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Change from baseline total energy expenditure
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Assessment method [10]
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Measured using the Fitbit(Charge HR). Difference from baseline number of calories spent per day. Assessed at baseline (2 days), weeks 1 and 3.
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Timepoint [10]
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Week 3
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Secondary outcome [11]
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Change from baseline performance status
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Assessment method [11]
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Measured using Australian-modified Karnofsky Performance Status (AKPS). Baseline, Stage1, Stage2, Stage3 and Stage 4.
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Timepoint [11]
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Up to week 15
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Secondary outcome [12]
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Change from baseline activities of daily living
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Assessment method [12]
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Measured using Barthel Index. Baseline and Stage 4.
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Timepoint [12]
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Up to week 15
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Secondary outcome [13]
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Change from baseline in sleep quality
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Assessment method [13]
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Rated on a 4 point Likert scale. Measured at baseline, weeks 1-3 (daily diary) and stage 4 (weekly diary).
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Timepoint [13]
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Up to week 15
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Secondary outcome [14]
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Change from baseline in objective sleep testing
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Assessment method [14]
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Thirty (30) participants at the Sydney and Adelaide sites will be invited to undertake a simple, non-invasive home sleep study using the ResMed ApneaLink Plus device. Baseline and Stage3.
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Timepoint [14]
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Week 3
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Secondary outcome [15]
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Change from baseline Polysomnography
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Assessment method [15]
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Up to ten (10) participants will also undergo two (baseline and Stage 1) in-laboratory overnight sleep studies in Sydney and Adelaide.
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Timepoint [15]
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Week 3
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Secondary outcome [16]
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Change from baseline Driving ability
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Assessment method [16]
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Twenty (20) participants in Adelaide and Sydney. Baseline and on day 2 and 7 of the first week in an office-based simulator - AusEd.
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Timepoint [16]
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Week 3 + 2 days
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Secondary outcome [17]
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Pharmacogenetic opioid profile - Number of participants with UGT2B7*2 and *28 polymorphisms
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Assessment method [17]
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The baseline blood samples will be analysed to detect the presence of UGT2B7*2 and *28 polymorphisms.
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Timepoint [17]
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Baseline (1 day)
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Secondary outcome [18]
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Pharmacogenetic opioid profile - Number of participants with P-glycoprotein polymorphism (ABCB1 5SNPs in a haplotype block)
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Assessment method [18]
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The baseline blood samples will be analysed to detect the presence of P-glycoprotein polymorphism (ABCB1 5SNPs in a haplotype block)
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Timepoint [18]
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Baseline (1 day)
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Secondary outcome [19]
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Pharmacogenetic opioid profile - Number of participants with 5-hydroxytryptamine type 3B (HTR3B) gene rs7103572 polymorphism
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Assessment method [19]
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The baseline blood samples will be analysed to detect the presence of 5-hydroxytryptamine type 3B (HTR3B) gene rs7103572 polymorphism
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Timepoint [19]
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Baseline (1 day)
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Secondary outcome [20]
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Pharmacogenetic opioid profile - Mu receptor (A118G) polymorphism
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Assessment method [20]
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The baseline blood samples will be analysed to detect the presence of Mu receptor (A118G) polymorphism
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Timepoint [20]
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Baseline (1 day)
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Secondary outcome [21]
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Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine Peak Plasma Concentration [Cmax]
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Assessment method [21]
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In a subset of 55 participants, morphine peak plasma concentrations will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).
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Timepoint [21]
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Week 1
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Secondary outcome [22]
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Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine Area Under the Curve (AUC)
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Assessment method [22]
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In a subset of 55 participants, morphine AUC will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).
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Timepoint [22]
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Week 1
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Secondary outcome [23]
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Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-6-glucuronide (M6G) Peak Plasma Concentration [Cmax]
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Assessment method [23]
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In a subset of 55 participants, M6G Peak Plasma Concentration will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).
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Timepoint [23]
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Week 1
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Secondary outcome [24]
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Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-6-glucuronide (M6G) Area Under the Curve (AUC)
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Assessment method [24]
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In a subset of 55 participants, M6G AUC will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).
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Timepoint [24]
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Week 1
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Secondary outcome [25]
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Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-3-glucuronide (M3G) Peak Plasma Concentration [Cmax]
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Assessment method [25]
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In a subset of 55 participants, M3G Peak Plasma Concentration will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).
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Timepoint [25]
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Week 1
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Secondary outcome [26]
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Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-3-glucuronide (M3G) Area Under the Curve (AUC)
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Assessment method [26]
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In a subset of 55 participants, M3G AUC will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).
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Timepoint [26]
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Week 1
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Secondary outcome [27]
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Change from baseline serum testosterone level
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Assessment method [27]
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Baseline and study completion. To explore whether longer term morphine treatment is associated with decreased levels of testosterone.
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Timepoint [27]
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Week 15
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Secondary outcome [28]
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Adverse Effects
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Assessment method [28]
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Rated on a Lickert Scale. Baseline, weeks 1-3 (daily diary), Stage 4 (weekly diary): Includes constipation, anxiety, appetite, nausea, vomiting, drowsiness, difficulty thinking clearly, problems passing urine, itch, other symptoms.
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Timepoint [28]
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Up to 15 weeks
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Secondary outcome [29]
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Change from baseline in concurrent symptoms
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Assessment method [29]
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Measured using the Edmonton Symptoms Assessment Scale (ESAS)
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Timepoint [29]
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Up to 15 weeks
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Secondary outcome [30]
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Change from the baseline anxiety and depression
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Assessment method [30]
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Rated using the Hospital Anxiety and Depression Scale (HADS). At baseline, completion of randomization stage and study exit.
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Timepoint [30]
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Up to Week 15
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Secondary outcome [31]
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Change in baseline global impression of change
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Assessment method [31]
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Participant-rated 7 point scale of the perception of their change, specifically their improvement since the commencement of the study. Measured at the end of Stages 1-3 and conclusion.
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Timepoint [31]
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Up to 15 weeks
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Secondary outcome [32]
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Change from baseline health-related quality of life
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Assessment method [32]
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Measured with EQ-5D-5L questionnaire. Baseline, Stages 1-3, Stage 4, conclusion.
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Timepoint [32]
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Up to 15 weeks
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Secondary outcome [33]
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Change from baseline health-status in COPD
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Assessment method [33]
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Measured with the COPD Assessment Test (CAT) Baseline, Stages 1-3, Stage 4 and conclusion.
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Timepoint [33]
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Week 3
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Secondary outcome [34]
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Blinded-patient preference to continue the treatment [3-point Likert Scale]
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Assessment method [34]
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Asked at the end of week 1 and at the conclusion/drop-out of the study. A 3-point Likert scale will be used.
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Timepoint [34]
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Up to week 15
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Secondary outcome [35]
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Change from baseline caregiver Impact
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Assessment method [35]
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Scored using the Zarit Burden Interview (ZBI) 12 item short-form questionnaire. Baseline, end of weeks 1-3, stage 4.
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Timepoint [35]
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Up to week 15
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Secondary outcome [36]
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Economic Evaluation - Cost per responder
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Assessment method [36]
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From randomisation to 28 days post treatment or death (whichever is the shorter period). Estimated based on all health-care contacts including length of hospitalizations, emergency department visits, DRG codes, community health visits, GP and community nurse visits, outpatient visits and date of death. These participant level data allow within trial modeling using bootstrapping methods of replicates for costs and consequences of alternative strategies, allowing for covariance between costs and effects. Incremental net monetary benefit and cost-effectiveness acceptability curves will be estimated at potential threshold values for an additional responder.
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Timepoint [36]
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Up to week 4
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Secondary outcome [37]
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Opioid Withdrawal
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Assessment method [37]
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Evaluation using the Subjective Opioid Withdrawal Scale (SOWS) for 3 consecutive days. After the completion of the study (Weeks 1-15).
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Timepoint [37]
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Up to week 15 + 3 days
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Eligibility
Key inclusion criteria
- 18 years of age or older.
- Physician diagnosed COPD confirmed by spirometry with the most recent result available
defined as a prior post-bronchodilator FEV1/FVC < 0.7 in accordance with the GOLD 2014
criteria.
- Respiratory physician confirmed optimisation of treatment of COPD.
- On stable medications relating to the optimal treatment of COPD or its symptomatic
management over the prior week except routine "as needed" medications.
- Breathlessness of a level three (3) or four (4) on the modified Medical Research
Council (mMRC) breathlessness scale.
- worst breathlessness intensity in the previous 24 hours was at least 3/10 on a 0-10
numerical rating scale (NRS).
- English speaking with sufficient reading and writing ability to complete the study
questionnaires
- Assessed as competent (using St Louise University Mental Status Examination (SLUMS)
score of 27/30 for people whose highest level of education was high school, and 25/30
for people who did not complete high school).
- Able and willing to give written informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- On any opioid for breathlessness in the previous seven (7) days.
- On regularly prescribed opioid medications for other conditions, including codeine
preparations at or above 8mg oral morphine equivalent daily dose (MEDD) in the
previous seven (7) days.
- History of adverse reactions to any of the study medications or constituents in the
placebo;
- Australian-modified Karnofsky performance score (AKPS) less than 50 at the beginning
of the study.
- Respiratory or cardiac event in the previous one week (excluding upper respiratory
tract infections). Illness must have resolved completely prior to baseline evaluation,
as judged by the person's treating physician.
- Evidence of respiratory depression with resting respiratory rate <8/min.
- Documented central hypoventilation syndrome.
- Current history of abuse of alcohol, or recent history of substance misuse.
- Uncontrolled nausea, vomiting or evidence of a gastrointestinal tract obstruction.
- Renal dysfunction with creatinine clearance calculated (MDRD) less than 20 mls/minute.
- Evidence of severe hepatic impairment defined as transaminases or bilirubin >4x normal
(Excluding Gilbert's syndrome)
- Pregnant or breastfeeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/08/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/12/2019
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Sample size
Target
171
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Clare Holland House - Canberra
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Recruitment hospital [2]
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Concord Hospital - Concord
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Recruitment hospital [3]
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St Vincent's Hospital Sydney - Sacred Heart Hospice - Darlinghurst
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Recruitment hospital [4]
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Calvary Health Care Kogarah - Kogarah
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Recruitment hospital [5]
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Liverpool Hospital - Liverpool
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Recruitment hospital [6]
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Westmead Hospital - Westmead
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Recruitment hospital [7]
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0
Prince Charles Hospital - Brisbane
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Recruitment hospital [8]
0
0
Nambour Hospital - Sunshine Coast
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Recruitment hospital [9]
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0
Southern Adelaide Palliative Services - Adelaide
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Recruitment hospital [10]
0
0
St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [11]
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0
Barwon Health McKellar Centre - Geelong
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Recruitment hospital [12]
0
0
The Austin Hospital - Heidelberg
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Recruitment hospital [13]
0
0
Royal Melbourne Hospital - Melbourne
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Recruitment hospital [14]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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2600 - Canberra
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [4]
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3590 - Kogarah
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Recruitment postcode(s) [5]
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0
2170 - Liverpool
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Recruitment postcode(s) [6]
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0
2145 - Westmead
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Recruitment postcode(s) [7]
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4032 - Brisbane
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Recruitment postcode(s) [8]
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4560 - Sunshine Coast
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Recruitment postcode(s) [9]
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0
5041 - Adelaide
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Recruitment postcode(s) [10]
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0
3065 - Fitzroy
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Recruitment postcode(s) [11]
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0
3215 - Geelong
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Recruitment postcode(s) [12]
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0
3084 - Heidelberg
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Recruitment postcode(s) [13]
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3050 - Melbourne
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Recruitment postcode(s) [14]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Flinders University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02720822
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David C Currow, MD, PhD
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Address
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Study Principal Investigator; Flinders University
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02720822
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