Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Aug 14;25(1):390.
doi: 10.1186/s12890-025-03862-z.

Motivations and experiences of patients with respiratory disease and their caregivers in a multinational trial of mirtazapine for severe breathlessness: a qualitative study (BETTER-B)

Adejoke O Oluyase  1 , Luca Ghirotto  2 , Harry Watson  3 , Massimo Costantini  3 , Sabrina Bajwah  3   4 , Charles Normand  3 , Silvia Tanzi  2 , Jeremias Bazata  5 , Karen Ryan  6 , Elena Turola  2 , Irene J Higginson  3   4 , Matthew Maddocks  3 ; BETTER-B consortium
Collaborators, Affiliations
Randomized Controlled Trial

Motivations and experiences of patients with respiratory disease and their caregivers in a multinational trial of mirtazapine for severe breathlessness: a qualitative study (BETTER-B)

Adejoke O Oluyase et al. BMC Pulm Med. .

Abstract

Background: Drug repurposing offers advantages over traditional drug development, such as shorter time and reduced costs. Understanding patient and caregiver perspectives on repurposed medicines is crucial to improving clinical trial design and conduct, especially in advanced disease. We carried out this study in the UK and Italy to explore the experiences and motivations of patients with respiratory diseases and their caregivers who participated in a trial investigating the repurposing of the antidepressant mirtazapine to alleviate severe breathlessness.

Methods: Qualitative study nested within a double-blind, placebo-controlled, randomised trial (BETTER-B: BETter TreatmEnts for Refractory Breathlessness). Purposive sampling ensured diversity in age and gender. Framework analysis was applied. Interviewed participants had Chronic Obstructive Pulmonary Disease (COPD) or Interstitial Lung Disease (ILD), experienced limiting breathlessness (grade 3 or 4 of the modified Medical Research Council breathlessness scale) and had participated in the trial.

Results: Twenty-three patients (13 men and 10 women) and eight caregivers (4 men and 4 women) were interviewed. Of patients (15 COPD, 8 ILD), 22 had completed the trial and one had withdrawn due to adverse effects. Interviews were conducted at home or via the telephone. Two main themes were derived: (1) 'knowledge and views about antidepressants and its use' and (2) 'experience and views on joining the trial'. The patients' perceived need for relief from severe breathlessness and its impact outweighed any concerns about taking an antidepressant. Motivations for trial participation included the potential for benefit, altruism, trust in the healthcare system, and the strength of relationships between patients and healthcare professionals.

Conclusions: Participants willing to accept mirtazapine repurposed for another indication joined this trial regardless of their existing concerns about antidepressants. A clear explanation of trials and possible benefits, plus trust in professionals and the healthcare system, are instrumental in increasing trial participation for repurposed medicines.

Trial registration: ISRCTN Registry, ISRCTN10487976. Prospectively Registered on 19 November 2019.

Keywords: Antidepressant; Breathlessness; Caregivers; Experiences; Mirtazapine; Motivations; Patients; Qualitative; Repurposing.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study received ethical approval from the London – Camberwell St Giles Research Ethics Committee (REC reference: 21/LO/0844) and Italian ethics committees (in-house prot. n. 248/2022/OSS/IRCCSRE). The study adhered to the Declaration of Helsinki. All participants provided informed consent prior to their involvement in the study. Consent for publication: Participants provided consent to have their anonymised quotes used for publication. Competing interests: IJH reports grants from the European Union (EU), Marie Curie Cancer Care, and National Institute for Health and Care Research (NIHR), and is Scientific Director of Cicely Saunders International, NIHR Emeritus Senior Investigator, and is an Honorary Clinical Consultant in Palliative Medicine for hospitals under Kings College Hospital National Health Service Foundation Trust outside of the submitted work. MM reports grants from the EU, UK Research and Innovation (UKRI), and NIHR. CN reports grants from the EU, payment of consulting fees from the World Health Organisation (WHO) and participation in the EMBED study advisory board. AOO reports grants from the Medical Research Foundation and honorarium for lectures at the Oxford Advanced Pain and Symptom Management Course. LG reports honorarium for teaching at the University of Modena and Reggio Emilia. KR and SB report grants from the EU. All other authors declare no competing interests.

References

    1. Krajnik M, Hepgul N, Wilcock A, Jassem E, Bandurski T, Tanzi S, et al. Do guidelines influence breathlessness management in advanced lung diseases? A multinational survey of respiratory medicine and palliative care physicians. BMC Pulm Med. 2022;22(1):41. - PMC - PubMed
    1. Currow DC, Chang S, Ekström M, Hutchinson A, Luckett T, Kochovska S, et al. Health service utilisation associated with chronic breathlessness: random population sample. ERJ Open Res. 2021. 10.1183/23120541.00415-2021. - PMC - PubMed
    1. Hutchinson A, Pickering A, Williams P, Bland JM, Johnson MJ. Breathlessness and presentation to the emergency department: a survey and clinical record review. BMC Pulm Med. 2017;17(1):53. - PMC - PubMed
    1. Currow D, Johnson M. Good news for chronic breathlessness from Down Under. EAPC Blog. Vilvoorde, Belgium: European Association for Palliative Care (EAPC); 2019. https://eapcnet.wordpress.com/2019/10/23/good-news-for-chronic-breathles....
    1. Simon ST, Higginson IJ, Bausewein C, Jolley CJ, Bajwah S, Maddocks M, et al. Practice review: pharmacological management of severe chronic breathlessness in adults with advanced life-limiting diseases. Palliat Med. 2024;38(10):1079–87. - PubMed

Publication types

MeSH terms

LinkOut - more resources