BETTER-B

Prüfplancode ISRCTN EudraCT Clinicaltrials.gov DRKS
SEP-210504851 folgt

Die BETTER-B Hauptstudie: eine internationale, multizentrische, randomisierte, kontrollierte Phase III-Studie zur Evaluation von Mirtazapin zur Linderung von Atemnot in Palliative Care

Status: Aktiv

Studienziel / Fragestellung

Primäres Prüfziel

To determine whether mirtazapine is an effective treatment for the relief of self-reported worst breathlessness in patients with COPD or ILD measured at 56 days from randomisation compared to placebo.

 

Sekundäre Prüfziele

  • To assess the effectiveness of mirtazapine, compared to placebo, at 7,14, 28, 56 and 180 days from randomisation on:

a. worst and average breathlessness over the previous 24 hours;

b. other physical symptoms and on overall Quality of Life;

c. anxiety, depression and sense of perceived self-efficacy;

d. the consumption of opioids;

e. healthcare use, in particular emergency hospital attendances and admissions;

  • 2. To evaluate safety, toxicity and tolerability of mirtazapine;
  • 3. To identify which patient characteristics are most associated with benefit from mirtazapine, specifically assessing the impact of: age: gender: functional status: aetiology: and baseline intensity of: breathlessness; anxiety; depression; and concomitant opioid administration;
  • 4. To assess the cost-effectiveness of mirtazapine treatment from a societal perspective (i.e. including formal and informal care received), when compared with best standard care;
  • 5. To demonstrate the feasibility of delivering mirtazapine treatment across the different European countries in terms of acceptability of the offered treatment and compliance with treatment, compared by different countries;
  • 6. To evaluate the impact of patients receiving mirtazapine on lay caregivers, in particular primary caregiver (family or friend) reports of their burdens and experience of caregiving, and the total hours of informal care.

Diagnose

  • Chronisch obstruktive Lungenerkrankung
  • Interstitielle Lungenerkrankung

Chronisch obstruktive Lungenerkrankung oder Interstitielle Lungenerkrankung mit Atemnot Grad 3 oder 4 nach mMRC (Modified Medical Research Council Dyspnoea Scale)

 

Patientenmerkmale

Alter

18 -

Studiendesign

Phase III, Multizentrisch, Zweiarmig, Doppelblind, Randomisiert, Parallel

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Leiter der klinischen Prüfung

Prof. Dr. med. Steffen Simon

Prüfzentren

Köln

Zentrum für Palliativmedizin

Status

Aktiv

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