Chronic Obstructive Pulmonary DiseaseNCT04360226
Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
An observational study of Chronic Obstructive Pulmonary Disease, run by Respiratory Effectiveness Group at 13 sites in 6 countries.
Trial summary
This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Non-interventional
- How many people
- 400 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 14 Dec 2020to 25 Jan 2024
- 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, who are clinically stable (4 exacerbations in previous 4 weeks) and have been taking inhaled medications for at least 6 months, but have no other chronic respiratory conditions, other than asthma or bronchiectasis.
Who may be able to join
- Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC<0.7)
- Age ≥40 years
- Smokers or ex-smokers of at least 10 pack-years
- Clinically stable COPD (no exacerbations in the last 4 weeks)
- Capable of performing serial lung function tests
- Prescribed inhaled medication for at least 6 months
Who cannot join
- Occurrence of an COPD exacerbation during the previous 4 weeks
- Have any concomitant chronic respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis, tuberculosis)
- Are unable to understand the instructions of the study or to fill the questionnaires
- Are unwilling to sign the informed consent
- Are participating in a clinical trial
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Spain5 sites
Hospital University de Torrecárdenas
Almería
University Hospital Vall d'Hebron
Barcelona
Hospital Inmaculada HLA
Granada
HU Virgen de las Nieves
Granada
Hospital Universitario de La Ribera
Valencia
South Korea3 sites
Hanyang University Guri Hospital
Hanyang
Seoul St. Mary's Hospital
Seoul
Ulsan University Hospital
Ulsan
Singapore2 sites
Changi General Hospital
Singapore
Singapore General Hospital
Singapore
About this study
This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Non-interventional
- 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.
Non-interventionalOther
Non-interventional, subjects will only have routine testing (blood biomarkers, spirometry, peak inspiratory flow measurements) and be asked to complete questionnaires.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of suboptimal PIF and inadequate inhaler choice.
Determine the prevalence of suboptimal PIF and inadequate inhaler choice.
Measured: Baseline
Exacerbations
Time to first exacerbation associated with different levels of PIF.
Measured: 12 months
Secondary outcomes (4)
PIF and symptom burden
PIF measurements will be correlated with COPD Assessment Test (CAT) Scores. CAT scores range from 0-40 depending on the severity of a persons symptoms; higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline, 6 and 12 months
Mortality
Annual mortality rate associated with different PIF levels.
Measured: 6 and 12 months
Variability and correlation of PIF
Variability of PIF over time and the correlation between PIF and other lung function measures (including FEV1, FVC, Inspiratory capacity), CAT scores, T2 markers (nasal polyps and dermatitis) and where available blood biomarkers.
Measured: Baseline, 6 and 12 months
Exacerbation rate
Annual rate of exacerbations associated with different PIF levels
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start14 Dec 2020
- Primary completion1 Aug 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respiratory Effectiveness Group
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Omar Usmani, MD, Principal investigator, National Heart and Lung Institute, Imperial College London & Royal Brompton Hosp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360226
- Sponsor's protocol ID
- REG-RES1801
- Status last verified
- Jan 2024
- First submitted
- 19 Apr 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
- ClinicalTrials.gov ID
- NCT04360226
- Acronym / sponsor ID
- REG-RES1801
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Respiratory Effectiveness GroupUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 24 Apr 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.
This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients, who are clinically stable (4 exacerbations in previous 4 weeks) and have been taking inhaled medications for at least 6 months, but have no other chronic respiratory conditions, other than asthma or bronchiectasis.
Key inclusion criteria (6 listed)
- Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC<0.7)
- Age ≥40 years
- Smokers or ex-smokers of at least 10 pack-years
- Clinically stable COPD (no exacerbations in the last 4 weeks)
- Capable of performing serial lung function tests
Key exclusion criteria (5 listed)
- Occurrence of an COPD exacerbation during the previous 4 weeks
- Have any concomitant chronic respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis, tuberculosis)
- Are unable to understand the instructions of the study or to fill the questionnaires
- Are unwilling to sign the informed consent
- Are participating in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNon-interventional, subjects will only have routine testing (blood biomarkers, spirometry, peak inspiratory flow measurements) and be asked to complete questionnaires. | Other | – |
Primary outcome
Prevalence of suboptimal PIF and inadequate inhaler choice.
Time frame: Baseline
Determine the prevalence of suboptimal PIF and inadequate inhaler choice.
Exacerbations
Time frame: 12 months
Time to first exacerbation associated with different levels of PIF.
4 secondary outcomes
PIF and symptom burden
Time frame: Baseline, 6 and 12 months
Mortality
Time frame: 6 and 12 months
Variability and correlation of PIF
Time frame: Baseline, 6 and 12 months
Exacerbation rate
Time frame: 6 and 12 months
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 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Omar Usmani, MD principal investigator
National Heart and Lung Institute, Imperial College London & Royal Brompton Hosp
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Respiratory Effectiveness Group at 13 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 6 inclusion and 5 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, South Korea, Singapore, Italy, Malta 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?
Prevalence of suboptimal PIF and inadequate inhaler choice. (time frame: Baseline). 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?
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 10 Apr 2024.