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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical COPD Questionnaire | Self reported health status of COPD | past 7 days (counted from day of study visit) |
| COPD Assessment Test (CAT) | Self reported health status of COPD | past 7 days (counted from day of study visit) [Note that the CAT has no explicit time frame] |
| Measure | Description | Time Frame |
|---|---|---|
| COPD Exacerbations | Self reported | past 12 months (counted from day of study visit) |
| Healthcare resource utilization | 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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Inclusion Criteria:
Exclusion Criteria:
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COPD patients aged forty years and older and who are treated with DPIs as a maintenance therapy
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| Name | Affiliation | Role |
|---|---|---|
| Janwillem Kocks, MD, PhD | General Practitioners Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolcock Institute of Medical Research, University of Sydney | Sydney | Australia | ||||
| University of Crete |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37592263 | Derived | Kocks J, Bosnic-Anticevich S, van Cooten J, Correia de Sousa J, Cvetkovski B, Dekhuijzen R, Dijk L, Garcia Pardo M, Gardev A, Gawlik R, van der Ham I, Janse Y, Lavorini F, Maricoto T, Meijer J, Metz B, Price D, Roman Rodriguez M, Schuttel K, Stoker N, Tsiligianni I, Usmani O, Voorham J, Leving MT. Identifying critical inhalation technique errors in Dry Powder Inhaler use in patients with COPD based on the association with health status and exacerbations: findings from the multi-country cross-sectional observational PIFotal study. BMC Pulm Med. 2023 Aug 17;23(1):302. doi: 10.1186/s12890-023-02566-6. | |
| 36575175 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| past 6 months (counted from day of study visit) |
| Heraklion |
| Greece |
| GPRI | Groningen | Netherlands |
| Medical University of Silesia | Katowice | Poland |
| Center Health Regional Administration (ARS Centro) | Aveiro | Portugal |
| Ibsalut | Soller | Balearic Islands | Spain |
| Derived |
| Leving MT, Bosnic-Anticevich S, van Cooten J, de Sousa JC, Cvetkovski B, Dekhuijzen R, Dijk L, Pardo MG, Gardev A, Gawlik R, van der Ham I, Janse Y, Lavorini F, Maricoto T, Meijer J, Metz B, Price D, Roman-Rodriguez M, Schuttel K, Stoker N, Tsiligianni I, Usmani O, Emerson-Stadler R, Kocks JWH. Clinical recommendations for dry powder inhaler use in the management of COPD in primary care. NPJ Prim Care Respir Med. 2022 Dec 27;32(1):59. doi: 10.1038/s41533-022-00318-3. |
| 34533772 | Derived | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |