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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04532853
Registration number
NCT04532853
Ethics application status
Date submitted
21/08/2020
Date registered
31/08/2020
Titles & IDs
Public title
Optimizing Maintenance Therapy in COPD Patients
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Scientific title
Optimizing Maintenance Therapy in COPD Patients: Real-world Observational Study of Peak Inspiratory Flow Rate, Inhalation Technique, and Medication Adherence
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Secondary ID [1]
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GPRI20103
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Universal Trial Number (UTN)
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Trial acronym
PIFOTAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
COPD patients -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical COPD Questionnaire
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Assessment method [1]
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Self reported health status of COPD
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Timepoint [1]
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past 7 days (counted from day of study visit)
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Primary outcome [2]
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COPD Assessment Test (CAT)
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Assessment method [2]
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Self reported health status of COPD
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Timepoint [2]
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past 7 days (counted from day of study visit) [Note that the CAT has no explicit time frame]
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Secondary outcome [1]
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COPD Exacerbations
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Assessment method [1]
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Self reported
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Timepoint [1]
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past 12 months (counted from day of study visit)
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Secondary outcome [2]
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Healthcare resource utilization
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Assessment method [2]
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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.
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Timepoint [2]
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past 6 months (counted from day of study visit)
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Eligibility
Key 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)
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/07/2021
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Sample size
Target
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Accrual to date
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Final
1434
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Woolcock Institute of Medical Research, University of Sydney - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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Greece
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State/province [1]
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Heraklion
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Country [2]
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Netherlands
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State/province [2]
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Groningen
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Country [3]
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Poland
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State/province [3]
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Katowice
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Country [4]
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Portugal
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State/province [4]
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Aveiro
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Country [5]
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Spain
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State/province [5]
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Islas Baleares
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Funding & Sponsors
Primary sponsor type
Other
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Name
General Practitioners Research Institute
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Boehringer Ingelheim
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/study/NCT04532853
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Janwillem Kocks, MD, PhD
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Address
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General Practitioners Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04532853