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Optimizing Maintenance Therapy in COPD Patients (PIFOTAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04532853
Recruitment Status : Completed
First Posted : August 31, 2020
Last Update Posted : July 27, 2021
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
General Practitioners Research Institute

Study Description
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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


Condition or disease
COPD

Study Design
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Study Type : Observational
Actual Enrollment : 1434 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Groups and Cohorts
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Group/Cohort
COPD patients


Outcome Measures
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Primary Outcome Measures :
  1. Clinical COPD Questionnaire [ Time Frame: past 7 days (counted from day of study visit) ]
    Self reported health status of COPD

  2. 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


Secondary Outcome Measures :
  1. COPD Exacerbations [ Time Frame: past 12 months (counted from day of study visit) ]
    Self reported

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients aged forty years and older and who are treated with DPIs as a maintenance therapy
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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Australia
Woolcock Institute of Medical Research, University of Sydney
Sydney, Australia
Greece
University of Crete
Heraklion, Greece
Netherlands
GPRI
Groningen, Netherlands
Poland
Medical University of Silesia
Katowice, Poland
Portugal
Center Health Regional Administration (ARS Centro)
Aveiro, Portugal
Spain
Ibsalut
Soller, Islas Baleares, Spain
Sponsors and Collaborators
General Practitioners Research Institute
Boehringer Ingelheim
Investigators
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Principal Investigator: Janwillem Kocks, MD, PhD General Practitioners Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: General Practitioners Research Institute
ClinicalTrials.gov Identifier: NCT04532853    
Other Study ID Numbers: GPRI20103
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by General Practitioners Research Institute:
COPD Exacerbations
Primary Care
Inhalation medication
Epidemiology
Treatment