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)

Flinders University0 个研究点目标入组 260 人开始时间: 2015年2月10日最近更新: 2020年1月13日

适应症

试验速览

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•* 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

•* 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
•* History of adverse reactions to morphine or constituents in the placebo.
•* Pregnant or breastfeeding.
•* Unable to achieve two baseline 6MWTs of at least 200m each

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