Sertraline for breathlessness | IMPACCT Trials Coordination Centre

Data set includes:

• 223 participants were included in the intention-to-treat analysis (112 receiving sertraline and 111 receiving Placebo)
• treatment period over 28 days with follow-up fortnightly for 4 weeks when possible.
• demographic, medical history data, concurrent medications, and baseline clinical measures
• Primary outcome data measured by average breathlessness on 100mm visual analogue scale and safety and toxicity data measured using the NCI CTCAE V4.0.

Other data for secondary analysis include

• Australia-modified Karnofsky Performance Status
• spirometry
• pulse oximetry
• resting respiratory rate
• pathology measures including full blood count, electrolyte function, renal function and serum sodium
• global impression of change
• blinded patient preference for symptomatic and net benefit
• MRC dyspnoea scale
• CRQ dyspnoae subscale
• EORTC- QLQ-15 and CQOLC
• measures of lifespace
• HADS
• breathlessness intensity and the degree to which it is unpleasant using VAS and four-point Likert scales
• dyspnoea scores for worst dyspnoea in the previous day measured on 0-10 NRS and a four point Likert scale
• severity ranking of dyspnoea target symptoms on Likert scales
• functional impairment scores on the MRC categorical scale
• Healthcare utilisation including number of inpatient admissions and days spent in hospital by level of dependency (low, medium, high)
• home care palliative care team visits
• general practitioner visits
• participant preference for where they prefer to be cared for given their current health state
   

Sertraline in symptomatic chronic breathlessness: a double-blind, randomised trial

Sertraline or placebo in chronic breathlessness? Lessons from placebo research