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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
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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