Effect of opioids on outcomes of pulmonary rehabilitatio

Phase 3

• Conditions: Chronic obstructive pulmonary disease; Respiratory - Chronic obstructive pulmonary disease; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12615000121561
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 260

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
* 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in exercise capacity, measured as the difference in mean distance between two standardized six minute walk tests (6MWTs) at week one and at week eight, respectively, of pulmonary rehabilitation by group.[Week eight of pulmonary rehabilitation]