COPDPIFOTALNCT04532853
Optimizing Maintenance Therapy in COPD Patients
An observational study of COPD, run by General Practitioners Research Institute at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- How many people
- 1,434 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 21 Oct 2020to 26 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients aged forty years and older and who are treated with DPIs as a maintenance therapy
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Australia1 site
Woolcock Institute of Medical Research, University of Sydney
Sydney
About this study
Official title: Optimizing Maintenance Therapy in COPD Patients: Real-world Observational Study of Peak Inspiratory Flow Rate, Inhalation Technique, and Medication Adherence
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.
Read more
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical COPD Questionnaire
Self reported health status of COPD
Measured: past 7 days (counted from day of study visit)
COPD Assessment Test (CAT)
Self reported health status of COPD
Measured: past 7 days (counted from day of study visit) [Note that the CAT has no explicit time frame]
Secondary outcomes (2)
COPD Exacerbations
Self reported
Measured: 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.
Measured: past 6 months (counted from day of study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start21 Oct 2020
- Primary completion31 May 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,434 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Janwillem Kocks, MD, PhD, Principal investigator, General Practitioners Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532853
- Sponsor's protocol ID
- GPRI20103
- Acronym
- PIFOTAL
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37592263Leving 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.
PubMed 36575175Leving 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.
PubMed 34533772
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Maintenance Therapy in COPD Patients: Real-world Observational Study of Peak Inspiratory Flow Rate, Inhalation Technique, and Medication Adherence
- ClinicalTrials.gov ID
- NCT04532853
- Acronym / sponsor ID
- PIFOTAL / GPRI20103
- Conditions
- COPD
- Keywords
- COPD Exacerbations, Primary Care, Inhalation medication, Epidemiology, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,434 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- Boehringer Ingelheim
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients aged forty years and older and who are treated with DPIs as a maintenance therapy
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical COPD Questionnaire
Time frame: past 7 days (counted from day of study visit)
Self reported health status of COPD
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
2 secondary outcomes
COPD Exacerbations
Time frame: past 12 months (counted from day of study visit)
Healthcare resource utilization
Time frame: past 6 months (counted from day of study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 37592263Kocks 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.
- Derived from this study: PubMed 36575175Leving 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.
- Derived from this study: PubMed 34533772Leving 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janwillem Kocks, MD, PhD principal investigator
General Practitioners Research Institute
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by General Practitioners Research Institute at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Greece, Netherlands, Poland, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical COPD Questionnaire (time frame: past 7 days (counted from day of study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04532853, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.