The goal of the PIFotal study is to examine predictors of optimal use of Dry Powder Inhalers (DPIs) in patients with COPD.

Background PIFotal study

COPD is a chronic progressive lung disease that affects 384 million patients worldwide. It results in loss of health and functional independence, poorer quality of life and is associated with increased healthcare resource utilization (HCRU) and an increased mortality risk. The dominant therapeutic strategy consists of maintenance therapy with Long Acting Bronchodilators which are frequently delivered through Dry Powder Inhaler (DPI) agents. Maintenance therapy is aimed at preserving health status. PIFR (i.e., Peak Inspiratory Flow Rate) and appropriate inhalation technique are important candidate prerequisites for the effectiveness of maintenance therapy. However, the prevalence of suboptimal PIFR and inhalation technique errors and their associations with the effectiveness of maintenance therapy are unknown. In this study we will investigate the association between PIFR and inhalation technique and the effectiveness of the treatment.
For more background information, see Inhalation technique.

The patients

The PIFotal study is aimed at patients:

• With a clinical diagnosis of COPD

• Aged 40 and older

• Who have used maintenance therapy through a DPI agent in the last 3 months or longer

What does participation mean for my patients?

The study will be conducted during 1 visit. This visit will take approximately 30-60 minutes. The figure on the left of this paragraph provides a graphical illustration of the study procedures.

Step 1. & 2. The clinician assesses whether the patient is eligible for participation.

Step 3. The patient is asked to provide written informed consent.

Step 4., 5. & 6. Subsequently, several measurements of the PIFR are performed.

Step 7. Then, patients will be asked to fill out questionnaires about their health and medication use.

Step 8. Next, the inhalation technique of the patient will be video recorded for later assessment.

Step 9. Lastly, if a patient makes one or more inhalation errors applicable, they will be offered tailored inhalation instructions to improve their inhalation technique.

Step 10. The study will be finished.

Would you be interested in participating in this study?

We are looking for GPs and pharmacists who would be willing to participate in the PIFotal study. With your help we hope to find patients who are eligible to participate in this study.
For the execution of the study, GPRI will provide a PIFotal toolbox. This box contains:

• An InCheck-DIAL G16 device to be used for the PIFR measurements.

• Questionnaires to be filled out by the patient.

• An iPad on which you can fill in the data in an electronic Case Report Form (eCRF) in the Castor EDC program.

• On the iPad you will find online training modules as well that prepare you to conduct the study in a seamless manner.

Of course, we are more than willing to support you in the execution of the study. So do not hesitate to contact us.
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