Optimizing Maintenance Therapy in COPD Patients (PIFOTAL)

Optimizing Maintenance Therapy in COPD Patients: Real-world Observational Study of Peak Inspiratory Flow Rate, Inhalation Technique, and Medication Adherence

Background: Effectiveness of maintenance therapy for COPD with Dry Powder Inhalers (DPIs) requires an optimal Peak Inspiratory Flow Rate (PIFR), a proper inhalation technique and adequate medication adherence from patients. Recent studies have suggested that patients with reduced peak inspiratory flow may have worse COPD-related symptom burden and increased risk of COPD-related hospitalizations. However, in primary care, little is known about how many COPD patients have suboptimal PIFR. Furthermore, there is a paucity of knowledge concerning the associations of PIFR, inhalation technique and medication adherence with the effectiveness of maintenance therapy.

Objective: To examine associations of PIFR, inhalation technique, and medication adherence with health status and disease, exacerbations, and healthcare resource utilization in patients with COPD receiving maintenance treatment with dry powder inhalers.

Study design: Cross-sectional observational study in five European countries*.

Study population: COPD patients aged 40 years or older who have received COPD maintenance therapy through DPIs in the past 3 months or longer.

Main study parameters: Health status as measured with the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), number of exacerbations, an assessment of PIFR, inhalation technique errors, medication adherence, healthcare resource utilization (HCRU), medication use and demographic and clinical covariates.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No significant burden from participating is expected. Risk of participating is deemed negligible. In addition, patients may benefit from participating. Specifically, patients who manifest inhalation errors, will receive a tailored inhalation instruction to remediate their inhalation errors. The impact of this instruction will not be evaluated in any way, therefore it should not be seen as an intervention.

* If the preplanned number of patients cannot be included also because of national outbreaks of SARS-COV-2 resulting in travel restrictions, participation will be sought from researchers from three other European countries

Study Overview

• Status: Completed
• Conditions: COPD

• Study Type: Observational
• Enrollment (Actual): 1434

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Woolcock Institute of Medical Research, University of Sydney
• Greece
  • Heraklion, Greece
    • University of Crete
• Netherlands
  • Groningen, Netherlands
    • GPRI
• Poland
  • Katowice, Poland
    • Medical University of Silesia
• Portugal
  • Aveiro, Portugal
    • Center Health Regional Administration (ARS Centro)
• Spain
  • Islas Baleares
    • Soller, Islas Baleares, Spain
      • Ibsalut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients aged forty years and older and who are treated with DPIs as a maintenance therapy

Description

Inclusion Criteria:

• A clinical diagnosis of COPD;
• Age ≥ 40;
• Use of maintenance therapy through a DPI in the last 3 months or longer
• Sufficient investigator-assessed decision-making capacity to provide informed consent (patients will not be invited if they have acute psychotic disorders, severe pervasive developmental disorders / severe intellectual disability or advanced neurodegenerative disease)

Exclusion Criteria:

• An exacerbation in the past 6 weeks (as this requires a patient to recover)
• Life threatening disease and life expectancy < 6 months (as inclusion of these patients is unethical)
• Participation in a randomized clinical trial on COPD medication

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COPD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical COPD Questionnaire	Self reported health status of COPD	past 7 days (counted from day of study visit)
COPD Assessment Test (CAT)	Self reported health status of COPD	past 7 days (counted from day of study visit) [Note that the CAT has no explicit time frame]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Exacerbations	Self reported	past 12 months (counted from day of study visit)
Healthcare resource utilization	Of primary care (consultations with GPs and primary care nurse), of secondary care (consultations with registrars or medical specialists in outpatient clinics, emergency departments, rate and duration of hospitalizations, and chest imaging/x-rays), of other healthcare provision (lung function technicians, physiotherapists, dietitians, and psychologists), as well as laboratory assessments and medication use.	past 6 months (counted from day of study visit)

Collaborators and Investigators

• Sponsor: General Practitioners Research Institute
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Janwillem Kocks, MD, PhD, General Practitioners Research Institute

Publications and helpful links

General Publications

• Leving M, Wouters H, de la Hoz A, Bosnic-Anticevich S, Dekhuijzen R, Gardev A, Lavorini F, Meijer J, Price D, Rodriguez MR, Tsiligianni I, Usmani O, Wijnsma B, Kocks J. Impact of PIF, Inhalation Technique and Medication Adherence on Health Status and Exacerbations in COPD: Protocol of a Real-World Observational Study (PIFotal COPD Study). Pulm Ther. 2021 Dec;7(2):591-606. doi: 10.1007/s41030-021-00172-7. Epub 2021 Sep 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2020
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): July 26, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Treatment; Primary Care; Epidemiology; COPD Exacerbations; Inhalation medication
• Other Study ID Numbers: GPRI20103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No