Effectiveness of prescribing similar vs dissimilar devices for COPD management (phase 2)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product

  Medical device
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients with Quality and Outcomes Framework (QOF) coded diagnosis for COPD ever recorded; aged ≥ 40 years at prescription date; ≥ 2 years of continuous practice data; ≥ 1 prescription for SABA, SAMA, LABA or LAMA as monotherapy or combinations (+/- ICS) via a single device or similar devices, prior to the prescription date; ≥ 1 prescription for baseline device(s) and additional COPD therapy (LABA, LAMA, ICS or their combinations) via a separate inhaler device in the outcome period (including that at prescription date).
• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  53817

Study design details

• Main study objective:
  -Compare the effectiveness (in terms of moderate and severe exacerbation prevention) of prescribing inhaler devices with similar inhalation techniques vs prescribing devices with dissimilar inhalation techniques in patients with COPD −Assess therapy adherence in patients with COPD prescribed inhaler devices with similar inhalation techni
• Outcomes:
  •Moderate and severe COPD exacerbation rate (sensitivity definition), •Short-acting beta2agonist (SABA) use•Adherence to COPD therapy
• Data analysis plan:
  Phase 2 of the study will investigate the effectiveness of comparable vs. non-comparable devices (as categorised in phase 1) in terms of excaerbation rate, SABA use and adherence to COPD therapy.