A study to establish whether further study of sertraline in relieving severe breathlessness is warranted.
- Conditions
- Intractable dyspnoeaRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12608000253303
- Lead Sponsor
- Repatriation General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
18 years of age or older
Intractable dyspnoea where the underlying cause has been maximally treated.
Dyspnoea at rest or with minimal exertion, as measured by a score of = 3 on the standard Medical Research Council categorical dyspnoea exertion scale.
On stable medications over the prior week Prognosis of at least 2 months
Current therapy with any one of the listed medications which involve a risk of serotonin syndrome or potentially significant drug-drug interactions.
Cognitive impairment with Folstein Mini-mental Status Exam <24/30.
Active respiratory or cardiac event in the previous 1 week.
Medical history of severe hepatic impairment
Medical history of gastro-intestinal bleeding.
Serum sodium less than 128mmol/l
Recent difficulty with seizure control
Inability to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in numerical rating scale of average morning and average evening breathlessness in the last 3 days of treatment (d26, d27, d28) compared with baseline, with a comparison between treatment groups.[Data from days 26, 27 & 28]
- Secondary Outcome Measures
Name Time Method