EP395-003

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled study to investigate the safety and tolerability of EP395 in patients with chronic obstructive pulmonary disease (COPD)

• IRAS ID

  1004396

• Contact name

  Dag Nesse

• Contact email

  dag@epiendo.com

• Sponsor organisation

  EpiEndo Pharmaceuticals

• Eudract number

  2021-005787-22

• Clinicaltrials.gov Identifier

  NCT05572333

• Research summary

  This study aims to investigate the safety and tolerability of a new medicinal product, EP395, in adult patients with chronic obstructive pulmonary disease (COPD). One patient group will receive EP395, the other group will receive placebo (contains no active ingredient). Neither patient nor study team will know what treatment has been allocated to the patient (blinded study). The medication is in the form of a capsule and has to be taken once daily.

  Summary of Results
  The findings demonstrate how informal carers navigate a path through complex cancer treatments and support their relative. A cancer diagnosis often requires multiple treatment visits to an oncology centre and this can be challenging for carers. They find that they need to co-ordinate and manage both health professionals and their care recipient(s) in terms of getting access to appropriate services and support. This process can be particularly challenging in the presence of a cognitive impairment that often demands effective communication with different agencies. Carers frequently experienced multiple challenges include dealing with the stigma and discrimination that is characteristic of the dementia experience and the added complexity of negotiating this within a cancer care context. Issues of decision-making, best interests and quality of life were also of central concern for carers. Carers within this particular context face complex challenges that are not necessarily obvious and appear under reported. Their role is often rendered invisible by the nature of the care recipients’ condition. We suggest health professionals need to respond to and support carers in different ways that do not stigmatise and hence discriminate against them.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  22/NW/0213

• Date of REC Opinion

  25 Aug 2022

• REC opinion

  Further Information Favourable Opinion