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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
Date last updated
27/07/2021

Titles & IDs
Public title
Optimizing Maintenance Therapy in COPD Patients
Scientific title
Optimizing Maintenance Therapy in COPD Patients: Real-world Observational Study of Peak Inspiratory Flow Rate, Inhalation Technique, and Medication Adherence
Secondary ID [1] 0 0
GPRI20103
Universal Trial Number (UTN)
Trial acronym
PIFOTAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
COPD patients -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical COPD Questionnaire
Timepoint [1] 0 0
past 7 days (counted from day of study visit)
Primary outcome [2] 0 0
COPD Assessment Test (CAT)
Timepoint [2] 0 0
past 7 days (counted from day of study visit) [Note that the CAT has no explicit time frame]
Secondary outcome [1] 0 0
COPD Exacerbations
Timepoint [1] 0 0
past 12 months (counted from day of study visit)
Secondary outcome [2] 0 0
Healthcare resource utilization
Timepoint [2] 0 0
past 6 months (counted from day of study visit)

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)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2021
Sample size
Target
Accrual to date
Final
1434
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research, University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Heraklion
Country [2] 0 0
Netherlands
State/province [2] 0 0
Groningen
Country [3] 0 0
Poland
State/province [3] 0 0
Katowice
Country [4] 0 0
Portugal
State/province [4] 0 0
Aveiro
Country [5] 0 0
Spain
State/province [5] 0 0
Islas Baleares

Funding & Sponsors
Primary sponsor type
Other
Name
General Practitioners Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Boehringer Ingelheim
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT04532853
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.
Public notes

Contacts
Principal investigator
Name 0 0
Janwillem Kocks, MD, PhD
Address 0 0
General Practitioners Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04532853