The effects of morphine on breathlessness and sleep in chronic obstructive pulmonary disease: A randomised, double-blind, placebo controlled cross-over study

Phase 2

Recruiting

• Conditions: chronic obstructive pulmonary disease; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12621000752864
• Lead Sponsor: Adelaide Institute for Sleep Health, Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 6 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Aged 18 years and older
-Chronic Obstructive Pulmonary Disease (COPD)
-Chronic breathlessness syndrome (as defined as a modified Medical Research Council breathlessness score of 2 or more)
-Optimal pharmacological treatment based on Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) 2021 Report
-An Australia-modified Karnofsky Performance Status (AKPS) scale score greater than or equal to 40

Exclusion Criteria

-Concurrent use of opioids, benzodiazepines, or monoamine-oxidase inhibitors, or within 7 days of such therapy
-Body mass index >40kg/m2
-Prior diagnosis of severe obstructive sleep apnea (apnea-hypopnea index more than 30 events/hr)
-Uncontrolled nausea, vomiting, or gastrointestinal obstruction
-Calculated creatinine clearance <25mL/min
-Two or more hepatic enzyme greater than or equal to 3 times the upper limit of normal
-International normalised ratio >1.2 in the absence of warfarin
-Unresolved cardiac or respiratory event in the past 7 days (excluding upper respiratory tract infections)
-Anaemia for which a blood transfusion was indicated for breathlessness in the past 12 months
-Pregnant, or childbearing potential not using contraception
-Breastfeeding
-Waiting list for lung transplantation
-Change in COPD medications in the past 7 days (except as needed medications)
-Use of home non-invasive ventilation (NIV)
-History of endotracheal intubation for respiratory failure
-History of severe COPD exacerbation requiring acute NIV
-History of opioid-related respiratory failure
-History of opioid dependence (as per the International Classification of Diseases and Health Problems (ICD-10) definition)
-Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep efficiency (% of total possible sleep time spent asleep) during overnight in-lab polysomnography.[Night three of the study, measured during the overnight in-lab sleep study ]

Secondary Outcome Measures

Name	Time	Method
Apnea-hypopnea index (AHI)[Night 3];Transcutaneous carbon dioxide level using a TcCO2 monitor.[Night 3];Breathlessness level via Breathlessless Now score, and modified BORG scale during external resistive load magnitude testing.[Night 3 and morning 4];Blood morphine concentration[Night 3 and morning 4];Opioid metabolism genotype via PCR.[Night 3];COPD assessment test (CAT) [Baseline and Morning 4];Hospital Anxiety and Depression (HAD) questionnaire[Baseline and Morning 4];Driving simulator performance to assess alertness. [Morning 4];Subjective sleepiness assessed via the Karolinska sleepiness scale.[Morning 4]