ACTRN12615000121561
Terminated
Phase 3
A randomised, double-blind, multi-site, parallel arm, fixed dose, placebo-controlled trial of the effects of morphine on exercise capacity and other outcomes of pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic obstructive pulmonary disease
- Sponsor
- Flinders University
- Enrollment
- 260
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Eligible for pulmonary rehabilitation as judged by the treating physician and the investigator
- •\* COPD verified by a post\-bronchodilator FEV1/FVC\<0\.7 on a previous spirometry
- •\* Age 18 years or more
- •\* English speaking and able to read study questionnaires (5th grade level)
- •\* On stable medications for breathlessness over the prior week except routine as needed” medications
- •\* Participant is capable of giving informed written consent, completing assessments, and complying with the study procedures
- •\* Breathlessness of a level 3 or 4 on the mMRC dyspnoea scale
Exclusion Criteria
- •\* Unstable cardiac or vascular disease within the previous four weeks.
- •\* Severely restricted performance status with AKPS score \< 50 at baseline.
- •\* Anaemia with hemoglobin \<10\.0g/dL as measured within one month of baseline evaluation for which transfusion would be indicated in the view of the treating physician.
- •\* History of chronic alcoholism or drug misuse problem.
- •\* On regular or ‘as needed’ (PRN) opioid medications, including codeine preparations at or above a dose equivalent to 20mg of morphine sulphate per 24 hours.
- •\* Renal dysfunction with creatinine clearance calculated \<20 mls/minute using the MDRD formula. (Severe renal impairment – AMH)
- •\* Hepatic impairment with serum alkaline phosphatase, total bilirubin, ALT or AST \> four times the upper limit of normal for the local laboratory.
- •\* Documented central hypoventilation syndrome.
- •\* Evidence of respiratory depression with resting respiratory rate \< 8\.
- •\* Participation in the current study at any time, or in a clinical study of a new chemical entity within the month prior to study entry
Outcomes
Primary Outcomes
Not specified
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