Clinical trial NCT04532853: Optimizing Maintenance Therapy in COPD Patients
Official title: Optimizing Maintenance Therapy in COPD Patients: Real-world Observational Study of Peak Inspiratory Flow Rate, Inhalation Technique, and Medication Adherence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD Exacerbations
Primary Care
Inhalation medication
Epidemiology
Treatment
Lead sponsor: General Practitioners Research Institute
Sponsor class: NETWORK
Collaborators: name: Boehringer Ingelheim
First posted: 2020-08-31
Enrollment: 1434
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients aged forty years and older and who are treated with DPIs as a maintenance therapy

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


Eligibility 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

Primary outcomes:
measure: Clinical COPD Questionnaire
timeFrame: past 7 days (counted from day of study visit)
measure: COPD Assessment Test (CAT)
timeFrame: past 7 days (counted from day of study visit) [Note that the CAT has no explicit time frame]
Secondary outcomes:
measure: COPD Exacerbations
timeFrame: past 12 months (counted from day of study visit)
measure: Healthcare resource utilization
timeFrame: past 6 months (counted from day of study visit)
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Woolcock Institute of Medical Research, University of Sydney
city: Heraklion
country: Greece
facility: University of Crete
city: Groningen
country: Netherlands
facility: GPRI
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Aveiro
country: Portugal
facility: Center Health Regional Administration (ARS Centro)
city: Soller
country: Spain
facility: Ibsalut
state: Islas Baleares
Study officials:
affiliation: General Practitioners Research Institute
name: Janwillem Kocks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.