None listed
Conditions
Brief summary
Sometimes drugs such as morphine help people who have severe lung disease feel less breathless when the course of the disease cannot be treated. Although morphine is frequently prescribed, there are limited data to quantify the benefit in this setting. There is growing evidence that different causes of breathlessness can lead to a variety of uncomfortable sensations (for example, “feeling tight” vs. “feeling suffocating”). Because of the recent availability of once daily morphine capsules, we are now able to do this important study and answer questions that will affect the quality of life of tens of thousands of people.
Interventions
Patients will be randomized in a double-blind fashion by the pharmacy’s central randomization service at The Repatriation General Hospital.
Each patient will be randomized to receive either a once-daily single 20mg KapanolTM capsule for 4 days followed 4 days of a once-daily single placebo capsule or vice versa. Patients will also receive 1-2 coloxyl with sennaTM tablets daily as prophylactic measure against constipation. Patients will be instructed that they can adjust the quantity and type of
Patients will be randomized in a double-blind fashion by the pharmacy’s central randomization service at The Repatriation General Hospital. Each patient will be randomized to receive either a once-daily single 20mg KapanolTM capsule for 4 days followed 4 days of a once-daily single placebo capsule or vice versa. Patients will also receive 1-2 coloxyl with sennaTM tablets daily as prophylactic measure against constipation. Patients will be instructed that they can adjust the quantity and type of laxative according to response and preference. Medications will be dispensed from the central pharmacy according to the blinded randomization scheme. Patients may continue any other ongoing dyspnoea management program that has been prescribed for them prior to entering the study, including oxygen, physical therapy, and non-opioid medications. Since the steady state of five-times Tmax will be reached at 45-60 hours, the maintenance of the study drug for four days will allow sufficient washout time. Analysis will be on days 4 and 8 of the study. Patients will be reviewed by the study investigators at randomisation, at the cross-over point, and at completion of the study (i.e. Days 0, 4, and 8). In addition, patients will be contacted by phone every 2 days when they are not seen by study investigators (i.e. Days 2 and 6) to follow their progress on the study and to monitor for adverse reactions. At the completion of the study or if the patient withdraws early, the patient will revert to their previously prescribed dyspnoea management program as they were receiving prior to beginning of the study.
Sponsors
Repatriation General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
English speaking. Dyspnoea as a symptom for which no treatment is likely to modify course of disease.Renal function within 2 times of normal as measured by serum creatinine.Able to fill out diary cards.On stable oxygen needs.On stable medications.Willing and able to give informed consent.Both male and female are eligible.
Exclusion criteria
On other opioid medications. Confusion and/or obtundation.Uncontrolled nausea or vomiting. True adverse reaction(s) to previous opioidsKnown hypersensitivity to morphine, morphine salts or any of the capsule components.Acute or severe bronchial asthma.Respiratory depression.Gastrointestinal obstruction or biliary colic .Concomitant use of Monoamine Oxidase Inhibitor(s) (MAOIs) in the last 2 weeks.Pregnancy or breast feeding mothers.Past history of substance abuse.
Outcome results
None listed