Chronic Obstructive Pulmonary DiseaseINCLINENCT05814484
Role of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of COPD
An observational study of Chronic Obstructive Pulmonary Disease and Adherence, Treatment, run by University of Leicester at 1 site in United Kingdom.
Trial summary
This is an observational study examining inhaler adherence and subsequent changes in blood eosinophil count in exacerbations of Chronic obstructive pulmonary disease (COPD) population. The study will run for 6 months as an observation period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Adherence, Treatment
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2023to Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients with frequent exacerbation events
Who may be able to join
- Clinical diagnosis of COPD documented by a health care provider with previous documented obstructive spirometry
- History of frequent exacerbations (defined as 2 or more exacerbations requiring oral corticosteroids and/or antibiotics within 12 months of pre-screening).
- Male or female participants aged ≥18 years.
- Willing and able to consent to participate in study.
- Able to use a smartphone device and comply with trial procedures.
- Participants with established triple therapy (ICS +LABA + LAMA) as controller at least 4 weeks prior to screening
Who cannot join
- Unable to give informed consent.
- Unable to use a smartphone device.
- Current or within the last 6 months (or maximum relevant wash out period, whichever is longer), participation in an investigational medicinal product (IMP) or device trial at the time of screening.
- Use of maintenance systemic corticosteroids within last 30 days.
- Patients whose treatment is considered palliative (life expectancy <6 months).
- History of unstable or severe cardiac, hepatic, or renal disease, or other medically significant illness, which the investigator believes, would be a contraindication to study participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Biomedical Research Centre, University of Leicester
Leicester, Leicestershire, LE1 9QP
About this study
Official title: An Observational Cohort Study of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of Chronic Obstructive Pulmonary Disease
This is an observational study examining inhaler adherence and subsequent changes in blood eosinophil count in exacerbations of Chronic obstructive pulmonary disease (COPD) population.
The study will run for 6 months as an observation period. Passive inhaler adherence monitoring will be done electronically via inhaler sensors connected to mobile Apps, and collecting symptoms questionnaires, diary of exacerbation events and trial visits predominantly in remote fashion. It will explore the feasibility of digital platform in clinical practice to collect the adherence data along with exacerbation events.
Read the detailed description
How Chronic Obstructive Pulmonary Disease (COPD) affects patients varies greatly among individuals. The concept of treatable traits, which identifies factors within an individual to allow targeted treatment has altered management strategies. The most commonly used biomarker for exacerbations of COPD is the blood eosinophil count [BEC], which tends to indicate a higher risk of exacerbations, but importantly is a biomarker of treatment response for corticosteroids.
Current pharmacological treatment for COPD is predominately based around inhaled therapy in the form of bronchodilators and inhaled corticosteroids (ICS) therapy.
However, almost half of the COPD population have been shown to poorly follow the prescribed inhaled therapy. This is important as a non-adherent trait may impact on BEC and result in unnecessary treatment escalation, increased risk to higher risk individuals (e.g. patients with high BEC) and lack of intervention around inhaler adherence.
Recent developments of digital platforms could potentially address this by capturing objective adherence data, unrecorded exacerbation events or if possible, anticipating the latter.
In summary, it is important to align inhaler adherence in conjunction with established biomarker, as is likely to help gain maximum benefit and better target interventions. In this study, the investigators propose the electronic monitoring of adherence and exacerbation reporting data along with the reflected changes in biomarkers and disease outcomes to lead a meaningful treatable trait approach in real-life setting.
- Keywords
- Blood Eosinophil Count, Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of exacerbation events
All exacerbation events during study period
Measured: 24 weeks
Secondary outcomes (9)
Number of participants who successfully completed the trial digital tasks
Participants who filled out electronic questionnaires and weekly symptom diaries
Measured: Month 6
Feasibility of digital platform
Number of exacerbation events captured by digital platform
Measured: Month 6
Change in blood eosinophil count over time
Peripheral blood eosinophil count
Measured: Month 1, 2,4 & 6
Change in lung function test
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1)
Measured: Month 0 & 6
Change in score of St George's Respiratory Questionnaire (SGRQ)
This 50-item questionnaire measures health status (quality of life) in patients with diseases of airway obstruction. Scores are broken down into 'symptoms' (normal participant range 9-15), 'activity' (normal participant range 7-12), 'impacts' (normal participant range 1-3), and a total score (normal participant range 5-7). Higher scores indicate poorer health status.
Measured: Month 0,2,4 & 6
Change in score of COPD Assessment Tool (CAT)
The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to measure the impact of COPD on a person's life, and how this changes over time. Scores range from 0-40, with higher scores indicating greater impact of COPD on a patient's life.
Measured: Month 0,2,4 & 6
Change in Extended MR dyspnoea score (eMRC)
This scale measures perceived respiratory disability. Participants rate their grades of breathlessness on a scale of 1 (least) to 5 (worst). The extension divides the grade 5 rating into 'a' (independent) and 'b' (dependent) to establish dependence on others for washing and dressing.
Measured: Month 0,2,4 & 6
Number of exacerbation events
To compare between T2H and non T2H groups regardless of adherence level
Measured: Month 6
Changes in blood eosinophil count
Comparison between nonT2high and T2high subgroups regardless of adherence rate
Measured: Month 1,2,4 & 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start10 Aug 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Aparito Ltd.
- Responsible party
- Sponsor
- Investigators
- Neil Greening, Principal investigator, University of Leicester, Biomedical Research Centre, Respiratory Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814484
- Sponsor's protocol ID
- 0884
- Acronym
- INCLINE
- Status last verified
- Jul 2023
- First submitted
- 22 Mar 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05814484
- Acronym / sponsor ID
- INCLINE / 0884
- Keywords
- Blood Eosinophil Count, Exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Aparito Ltd.
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Apr 2023 (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 observational study examining inhaler adherence and subsequent changes in blood eosinophil count in exacerbations of Chronic obstructive pulmonary disease (COPD) population.
The study will run for 6 months as an observation period. Passive inhaler adherence monitoring will be done electronically via inhaler sensors connected to mobile Apps, and collecting symptoms questionnaires, diary of exacerbation events and trial visits predominantly in remote fashion. It will explore the feasibility of digital platform in clinical practice to collect the adherence data along with exacerbation events.
Detailed description
How Chronic Obstructive Pulmonary Disease (COPD) affects patients varies greatly among individuals. The concept of treatable traits, which identifies factors within an individual to allow targeted treatment has altered management strategies. The most commonly used biomarker for exacerbations of COPD is the blood eosinophil count [BEC], which tends to indicate a higher risk of exacerbations, but importantly is a biomarker of treatment response for corticosteroids.
Current pharmacological treatment for COPD is predominately based around inhaled therapy in the form of bronchodilators and inhaled corticosteroids (ICS) therapy.
However, almost half of the COPD population have been shown to poorly follow the prescribed inhaled therapy. This is important as a non-adherent trait may impact on BEC and result in unnecessary treatment escalation, increased risk to higher risk individuals (e.g. patients with high BEC) and lack of intervention around inhaler adherence.
Recent developments of digital platforms could potentially address this by capturing objective adherence data, unrecorded exacerbation events or if possible, anticipating the latter.
In summary, it is important to align inhaler adherence in conjunction with established biomarker, as is likely to help gain maximum benefit and better target interventions. In this study, the investigators propose the electronic monitoring of adherence and exacerbation reporting data along with the reflected changes in biomarkers and disease outcomes to lead a meaningful treatable trait approach in real-life setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with frequent exacerbation events
Key inclusion criteria (6 listed)
- Clinical diagnosis of COPD documented by a health care provider with previous documented obstructive spirometry
- History of frequent exacerbations (defined as 2 or more exacerbations requiring oral corticosteroids and/or antibiotics within 12 months of pre-screening).
- Male or female participants aged ≥18 years.
- Willing and able to consent to participate in study.
- Able to use a smartphone device and comply with trial procedures.
Key exclusion criteria (6 listed)
- Unable to give informed consent.
- Unable to use a smartphone device.
- Current or within the last 6 months (or maximum relevant wash out period, whichever is longer), participation in an investigational medicinal product (IMP) or device trial at the time of screening.
- Use of maintenance systemic corticosteroids within last 30 days.
- Patients whose treatment is considered palliative (life expectancy <6 months).
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
Total number of exacerbation events
Time frame: 24 weeks
All exacerbation events during study period
9 secondary outcomes
Number of participants who successfully completed the trial digital tasks
Time frame: Month 6
Feasibility of digital platform
Time frame: Month 6
Change in blood eosinophil count over time
Time frame: Month 1, 2,4 & 6
Change in lung function test
Time frame: Month 0 & 6
Change in score of St George's Respiratory Questionnaire (SGRQ)
Time frame: Month 0,2,4 & 6
Change in score of COPD Assessment Tool (CAT)
Time frame: Month 0,2,4 & 6
Change in Extended MR dyspnoea score (eMRC)
Time frame: Month 0,2,4 & 6
Number of exacerbation events
Time frame: Month 6
Changes in blood eosinophil count
Time frame: Month 1,2,4 & 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- 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.
Neil Greening principal investigator
University of Leicester, Biomedical Research Centre, Respiratory Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Adherence, Treatment, run by University of Leicester at 1 site in United Kingdom.
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 6 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hnin WW Aung, MBBS (+447949813009, hwwa1@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of exacerbation events (time frame: 24 weeks). 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 19 Jul 2023.