Describing inhaler errors when mixing various inhaler types on inhaler technique in Chronic Obstructive Pulmonary Disease (COPD): MISMATCH study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50616
• EU PAS number:
  EUPAS48776
• Study ID:
  50616
• Official title and acronym:
  Describing inhaler errors when mixing various inhaler types on inhaler technique in Chronic Obstructive Pulmonary Disease (COPD): MISMATCH study
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Background: Inhaled drug therapy is the cornerstone of COPD treatment. However, correct use of inhaler devices can be challenging. Incorrect use may affect drug delivery to the lungs and consequently therapy effectiveness. There is some evidence that handling errors will occur more frequently when a patient uses a mixture of inhalers that require very different techniques, such as a dry powder inhaler (DPI) together with a pressurised metered dose inhaler (pMDI), which is common in treatment of COPD. This study hypothesises that patients using a mixture of a DPI and a pMDI will make more and different types of inhaler technique errors, which are otherwise not recognised or accounted for in inhaler technique checklists, than patients using a DPI only. Some of these errors may lead to poorer outcomes in patients with COPD. The study will compare the nature and frequency of inhaler technique errors, by describing all errors observed rather than using pre-determined checklists, between two groups of patients with COPD: 1. Patients using a combination of a DPI and a pMDI (“Mixed-devices group”) 2. Patients using a single DPI (“DPI only group”) In addition, the study will explore to which extent specific inhaler technique errors can explain potential differences in COPD health status and/or exacerbation rate between both groups. Study design: Cross-sectional observational study reassessing the recorded videos of DPI inhaler technique obtained from participants of the PIFotal study. All types of errors, including actions that should be part of the pMDI technique, will be assessed. Study population: Patients (age ≥40 years) who received COPD maintenance therapy through a DPI in the last 3 months prior to inclusion in the PIFotal study. Data source: Participants of the PIFotal study from the Netherlands, Poland, Greece, Portugal and Spain. Sample size: 292 patients in the “Mixed-devices group” will be matched o a patient using the same DPI device only
• Study status:
  Ongoing

Research institutions and networks

Institutions

General Practitioners Research Institute (GPRI)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 01/07/2022

Actual: 11/07/2022

Study start date

Planned: 01/08/2022

Actual: 01/09/2022

Data analysis start date

Planned: 12/10/2022

Actual: 15/10/2022

Date of final study report

Planned: 15/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chiesi Pharmaceuticals BV, the Netherlands

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable