A pragmatic, cluster randomized trial evaluating the impact of an enhanced adherence package (dual bronchodilator+add-on+app) on time to treatment failure and other clinical outcomes in exacerbating COPD patients with poor adherence to mono or dual therapy over one year (MAGNIFY)

Study type

• Study type:
  Clinical trial

Clinical trials

• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1312

Study design details

• Main study objective:
  The primary objective of this study is to assess the time to treatment failure in patients on Ultibro®+add-on device+app (“adherence support arm” ASA) compared with patients receiving usual routine clinical care. This assessment will focus on patients who are suitable for, and accept the add-on device/app technology (primary populations). 2
• Outcomes:
  Time to treatment failure, where treatment failure is defined as the first occurrence of: • Moderate/severe COPD exacerbation • Prescription of triple therapy (ICS/LABA/LAMA) • Prescription of additional chronic therapy • Respiratory-related death, 1) Adherence (based on prescription (Rx) refill records over 12 months) 2) Moderate/severe exacerbations (in terms of the proportion of patients with at least one moderate/severe exacerbation at 12 months, and total number of exacerbations at 12 months)
• Data analysis plan:
  For primary analysis, time-to-event analysis will be performed to analyse the association between intervention and time to first outcome event (treatment failure) with censoring at the time of death or loss to follow-up.