ACTRN12621000752864
Recruiting
Phase 2
The effects of morphine on breathlessness and sleep in chronic obstructive pulmonary disease: A randomised, double-blind, placebo controlled cross-over study
Adelaide Institute for Sleep Health, Flinders University0 sites22 target enrollmentJune 15, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- chronic obstructive pulmonary disease
- Sponsor
- Adelaide Institute for Sleep Health, Flinders University
- Enrollment
- 22
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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