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Breathlessness Exertion and Morphine Sulphate (BEAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02720822
Recruitment Status : Recruiting
First Posted : March 28, 2016
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
David Currow, Flinders University

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dyspnea Drug: Placebo Drug: Morphine Sulfate Drug: Plus laxative (Docusate with senna) Drug: Plus placebo laxative Device: FitBit charge HR (Accelerometer) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 8, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Double-blind placebo capsule, looking identical to capsules with active treatment, during all three treatment weeks.
Drug: Placebo
Treatment with placebo is given as one double-blind capsule in the morning.
Other Name: MP342

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.

Experimental: Morphine Sulfate (0, 0, 8 mg)
Placebo on weeks one and two. Morphine 8 mg/day on week three.
Drug: Placebo
Treatment with placebo is given as one double-blind capsule in the morning.
Other Name: MP342

Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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.

Experimental: Morphine sulfate (0, 8, 8 mg)
Placebo on week one. Morphine 8 mg/day on weeks two and three.
Drug: Placebo
Treatment with placebo is given as one double-blind capsule in the morning.
Other Name: MP342

Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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.

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.
Drug: Placebo
Treatment with placebo is given as one double-blind capsule in the morning.
Other Name: MP342

Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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.

Experimental: Morphine sulfate (8, 8, 8 mg)
Morphine 8 mg/day on weeks one, two and three.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.

Experimental: Morphine sulfate (8, 8, 16 mg)
Morphine 8 mg/day on weeks one and two. Morphine 16 mg/day on week three.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.

Experimental: Morphine sulfate (8, 16, 16 mg)
Morphine 8 mg/day on week one. Morphine 16 mg/day on weeks two and three.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.

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.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.

Experimental: Morphine sulfate (16, 16, 16 mg)
Morphine 16 mg/day on weeks one, two and three.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.

Experimental: Morphine sulfate (16, 16, 24 mg)
Morphine 16 mg/day on weeks one and two. Morphine 24 mg/day on week three.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.

Experimental: Morphine sulfate (16, 24, 24 mg)
Morphine 16 mg/day on week one. Morphine 24 mg/day on weeks two and three.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.

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.
Drug: Morphine Sulfate
Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
Other Name: Kapanol (R)

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).

Device: FitBit charge HR (Accelerometer)
A Fitbit will be worn by patients during week 1 and week 3.




Primary Outcome Measures :
  1. Change from baseline worst breathlessness intensity over the previous 24 hours [ Time Frame: Week 1 ]

    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)

  2. Change from the baseline in the number of steps per day [ Time Frame: Week 3 ]

    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


Secondary Outcome Measures :
  1. Change from baseline end-tidal carbon dioxide [ Time Frame: Up to week 15 ]
    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.

  2. Change from baseline pulse oximetry [ Time Frame: Up to week 15 ]
    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.

  3. Change from baseline intensity of breathlessness "average" [ Time Frame: Up to week 15 ]
    Rated on a 0-10 numerical rating scale (NRS). Measured at baseline, weeks 1-3 (daily diary) and stage 4 (weekly diary).

  4. Change from baseline distress from breathlessness over the previous 24 hours [ Time Frame: Up to week 15 ]
    Rated on a 0-10 numerical rating scale (NRS). Measured at baseline, weeks 1-3 (daily diary) and stage 4 (weekly diary).

  5. Change from baseline perceived-impact of breathlessness [ Time Frame: Up to week 3 ]
    Chronic Respiratory Questionnaire - Dyspnoea and Mastery Subscales. Baseline and end of Weeks 1-3.

  6. Change from baseline functional impact of breathlessness [ Time Frame: Up to week 15 ]
    Rated on the Modified Medical Research Council Breathlessness Scale (mMRC). Measured at baseline and at the conclusion of the study.

  7. Change from baseline sleep minutes [ Time Frame: Week 3 ]
    Measured using the Fitbit(Charge HR). Assessed at baseline (2 days), weeks 1 and 3.

  8. Change from baseline sleep activity [ Time Frame: Week 3 ]
    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.

  9. Change from baseline in activity levels [ Time Frame: Week 3 ]
    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.

  10. Change from baseline total energy expenditure [ Time Frame: Week 3 ]
    Measured using the Fitbit(Charge HR). Difference from baseline number of calories spent per day. Assessed at baseline (2 days), weeks 1 and 3.

  11. Change from baseline performance status [ Time Frame: Up to week 15 ]
    Measured using Australian-modified Karnofsky Performance Status (AKPS). Baseline, Stage1, Stage2, Stage3 and Stage 4.

  12. Change from baseline activities of daily living [ Time Frame: Up to week 15 ]
    Measured using Barthel Index. Baseline and Stage 4.

  13. Change from baseline in sleep quality [ Time Frame: Up to week 15 ]
    Rated on a 4 point Likert scale. Measured at baseline, weeks 1-3 (daily diary) and stage 4 (weekly diary).

  14. Change from baseline in objective sleep testing [ Time Frame: Week 3 ]
    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.

  15. Change from baseline Polysomnography [ Time Frame: Week 3 ]
    Up to ten (10) participants will also undergo two (baseline and Stage 1) in-laboratory overnight sleep studies in Sydney and Adelaide.

  16. Change from baseline Driving ability [ Time Frame: Week 3 + 2 days ]
    Twenty (20) participants in Adelaide and Sydney. Baseline and on day 2 and 7 of the first week in an office-based simulator - AusEd.

  17. Pharmacogenetic opioid profile - Number of participants with UGT2B7*2 and *28 polymorphisms [ Time Frame: Baseline (1 day) ]
    The baseline blood samples will be analysed to detect the presence of UGT2B7*2 and *28 polymorphisms.

  18. Pharmacogenetic opioid profile - Number of participants with P-glycoprotein polymorphism (ABCB1 5SNPs in a haplotype block) [ Time Frame: Baseline (1 day) ]
    The baseline blood samples will be analysed to detect the presence of P-glycoprotein polymorphism (ABCB1 5SNPs in a haplotype block)

  19. Pharmacogenetic opioid profile - Number of participants with 5-hydroxytryptamine type 3B (HTR3B) gene rs7103572 polymorphism [ Time Frame: Baseline (1 day) ]
    The baseline blood samples will be analysed to detect the presence of 5-hydroxytryptamine type 3B (HTR3B) gene rs7103572 polymorphism

  20. Pharmacogenetic opioid profile - Mu receptor (A118G) polymorphism [ Time Frame: Baseline (1 day) ]
    The baseline blood samples will be analysed to detect the presence of Mu receptor (A118G) polymorphism

  21. Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine Peak Plasma Concentration [Cmax] [ Time Frame: Week 1 ]
    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).

  22. Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine Area Under the Curve (AUC) [ Time Frame: Week 1 ]
    In a subset of 55 participants, morphine AUC will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).

  23. Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-6-glucuronide (M6G) Peak Plasma Concentration [Cmax] [ Time Frame: Week 1 ]
    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).

  24. Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-6-glucuronide (M6G) Area Under the Curve (AUC) [ Time Frame: Week 1 ]
    In a subset of 55 participants, M6G AUC will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).

  25. Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-3-glucuronide (M3G) Peak Plasma Concentration [Cmax] [ Time Frame: Week 1 ]
    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).

  26. Pharmacokinetic (PK)/ Pharmacodynamic (PD) opioid profile: Morphine-3-glucuronide (M3G) Area Under the Curve (AUC) [ Time Frame: Week 1 ]
    In a subset of 55 participants, M3G AUC will be analysed (4 blood samples over 8 hours) at steady state (end of week 1).

  27. Change from baseline serum testosterone level [ Time Frame: Week 15 ]
    Baseline and study completion. To explore whether longer term morphine treatment is associated with decreased levels of testosterone.

  28. Adverse Effects [ Time Frame: Up to 15 weeks ]
    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.

  29. Change from baseline in concurrent symptoms [ Time Frame: Up to 15 weeks ]
    Measured using the Edmonton Symptoms Assessment Scale (ESAS)

  30. Change from the baseline anxiety and depression [ Time Frame: Up to Week 15 ]
    Rated using the Hospital Anxiety and Depression Scale (HADS). At baseline, completion of randomization stage and study exit.

  31. Change in baseline global impression of change [ Time Frame: Up to 15 weeks ]
    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.

  32. Change from baseline health-related quality of life [ Time Frame: Up to 15 weeks ]
    Measured with EQ-5D-5L questionnaire. Baseline, Stages 1-3, Stage 4, conclusion.

  33. Change from baseline health-status in COPD [ Time Frame: Week 3 ]
    Measured with the COPD Assessment Test (CAT) Baseline, Stages 1-3, Stage 4 and conclusion.

  34. Blinded-patient preference to continue the treatment [3-point Likert Scale] [ Time Frame: Up to week 15 ]
    Asked at the end of week 1 and at the conclusion/drop-out of the study. A 3-point Likert scale will be used.

  35. Change from baseline caregiver Impact [ Time Frame: Up to week 15 ]
    Scored using the Zarit Burden Interview (ZBI) 12 item short-form questionnaire. Baseline, end of weeks 1-3, stage 4.

  36. Economic Evaluation - Cost per responder [ Time Frame: Up to week 4 ]
    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.

  37. Opioid Withdrawal [ Time Frame: Up to week 15 + 3 days ]
    Evaluation using the Subjective Opioid Withdrawal Scale (SOWS) for 3 consecutive days. After the completion of the study (Weeks 1-15).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720822


Contacts
Layout table for location contacts
Contact: David C Currow, MD, PhD +61 8 7221 8235 david.currow@flinders.edu.au
Contact: Belinda S Fazekas, BN +61 8 8275 1396 belinda.fazekas@.sa.gov.au

Locations
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Australia, Australian Capital Territory
Clare Holland House Recruiting
Canberra, Australian Capital Territory, Australia, 2600
Contact: Nick Glasgow       nick.glasgow@calvary-act.gov.au   
Contact: Susanne Rainsford       Susanne.rainsford@calvary-act.gov.au   
Principal Investigator: Suharsha Kanathigoda         
Australia, New South Wales
Concord Hospital Recruiting
Concord, New South Wales, Australia, 2139
Contact: Mary-Rose Birch       mary-rose.birch@health.nsw.gov.au   
Principal Investigator: Jessica Lee         
St Vincent's Hospital Sydney - Sacred Heart Hospice Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Frances Bellemore       Frances.Bellemore@svha.org.au   
Contact: Viola Chan       tsz.chan@svha.org.au   
Principal Investigator: Richard Chye         
Calvary Health Care Kogarah Recruiting
Kogarah, New South Wales, Australia, 3590
Contact: Ruth Dunleavey       ruth.dunleavey@health.nsw.gov.au   
Principal Investigator: Caitlin Sheehan         
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Robin O'Reilly       robin.o'reilly@sswahs.nsw.gov.au   
Principal Investigator: Rajesh Aggarwal         
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Jan Gesling       jan.gesling@health.nsw.gov.au   
Contact: Tracey Burns       tracey.burns@health.nsw.gov.au   
Principal Investigator: John Wheatley         
Australia, Queensland
Prince Charles Hospital Recruiting
Brisbane, Queensland, Australia, 4032
Contact: Deborah Courtney       deborah_courtney@health.qld.gov.au   
Principal Investigator: Kwun Fong         
Nambour Hospital Recruiting
Sunshine Coast, Queensland, Australia, 4560
Contact: Diana Charlesworth       diana.charlesworth@health.qld.gov.au   
Principal Investigator: Louise Welch         
Australia, South Australia
Southern Adelaide Palliative Services Recruiting
Adelaide, South Australia, Australia, 5041
Contact: Lesley Burke       Lesley.burke@sa.gov.au   
Contact: Urska Cosic       urska.cosic@health.sa.gov.au   
Principal Investigator: Peter Allcroft         
Australia, Victoria
St Vincent's Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Di Saward       di.saward@svha.org.au   
Contact: Indy Khera       indy.khera@svha.org.au   
Principal Investigator: Jennifer Philip         
Barwon Health McKellar Centre Recruiting
Geelong, Victoria, Australia, 3215
Contact: Anna Dowd       annado@barwonhealth.org.au   
Principal Investigator: Peter Eastman         
The Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Lisa Fuhrmeister       lisa.fuhrmeister@austin.org.au   
Principal Investigator: Christine McDonald         
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Gillian McCarthy       Gillian.McCarthy@mh.org.au   
Principal Investigator: Brian Le         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Perth, Western Australia, Australia, 6009
Contact: Anu Krishnan       anu.krishnan@health.wa.gov.au   
Principal Investigator: Anu Krishnan         
Sponsors and Collaborators
Flinders University
Investigators
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Principal Investigator: David C Currow, MD, PhD Study Principal Investigator; Flinders University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: David Currow, Professor: Palliative and Supportive Services, Flinders University
ClinicalTrials.gov Identifier: NCT02720822     History of Changes
Other Study ID Numbers: 030/15
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Dyspnea
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Morphine
Laxatives
Cathartics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents