Optimizing Maintenance Therapy in COPD Patients (PIFOTAL)
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|ClinicalTrials.gov Identifier: NCT04532853|
Recruitment Status : Completed
First Posted : August 31, 2020
Last Update Posted : July 27, 2021
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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1434 participants|
|Official Title:||Optimizing Maintenance Therapy in COPD Patients: Real-world Observational Study of Peak Inspiratory Flow Rate, Inhalation Technique, and Medication Adherence|
|Actual Study Start Date :||October 21, 2020|
|Actual Primary Completion Date :||May 31, 2021|
|Actual Study Completion Date :||July 26, 2021|
- Clinical COPD Questionnaire [ Time Frame: past 7 days (counted from day of study visit) ]Self reported health status of COPD
- COPD Assessment Test (CAT) [ Time Frame: past 7 days (counted from day of study visit) [Note that the CAT has no explicit time frame] ]Self reported health status of COPD
- COPD Exacerbations [ Time Frame: past 12 months (counted from day of study visit) ]Self reported
- Healthcare resource utilization [ Time Frame: past 6 months (counted from day of study visit) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532853
|Woolcock Institute of Medical Research, University of Sydney|
|University of Crete|
|Medical University of Silesia|
|Center Health Regional Administration (ARS Centro)|
|Soller, Islas Baleares, Spain|
|Principal Investigator:||Janwillem Kocks, MD, PhD||General Practitioners Research Institute|