Optimizing Maintenance Therapy in COPD Patients

NCT04532853 | Completed

• 1 other identifier: GPRI20103
• Study Type: observational
• Target: 1,434
• Locations: 6 countries
• Sites: 6

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

Conditions

COPD

Keywords

COPD Exacerbations; Primary Care; Inhalation medication; Epidemiology; Treatment

Outcome Measures

Primary Outcomes (2)

• 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]

Secondary Outcomes (2)

• COPD Exacerbations

  past 12 months (counted from day of study visit)

• Healthcare resource utilization

  past 6 months (counted from day of study visit)

Study Arms (1)

COPD patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients aged forty years and older and who are treated with DPIs as a maintenance therapy

You may qualify if:

• 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)

You may not qualify if:

• An exacerbation in the past 6 weeks (as this requires a patient to recover)
• Participation in a randomized clinical trial on COPD medication

Sponsors & Collaborators

• General Practitioners Research Institute: lead
• Boehringer Ingelheim: collaborator

Study Sites (6)

Woolcock Institute of Medical Research, University of Sydney

Sydney, Australia

Location

University of Crete

Heraklion, Greece

Location

GPRI

Groningen, Netherlands

Location

Medical University of Silesia

Katowice, Poland

Location

Center Health Regional Administration (ARS Centro)

Aveiro, Portugal

Location

Ibsalut

Soller, Balearic Islands, Spain

Location

Related Publications (3)

• 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.

  PMID: 37592263 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.

  PMID: 36575175 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.

  PMID: 34533772 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janwillem Kocks, MD, PhD

  General Practitioners Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 31, 2020
• Study Start: October 21, 2020
• Primary Completion: May 31, 2021
• Study Completion: July 26, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

PT (1); ES (1); AU (1); GR (1); PL (1); NL (1)