COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory InfectionOMRONNCT06061679
Impact of Switching COPD Patients From Inhaler Devices to the Omron C28P Nebuliser.
A study testing Omron C28P nebuliser in people with COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The cornerstone of COPD therapy is based on the use of inhalation drugs. The correct use of devices is crucial; a suboptimal use technique is the cause of a possible clinical deterioration with a consequent increase in exacerbations and healthcare expenditure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection
- What is being tested?
- Omron C28P nebuliser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- COPD patients treated by inhaled bronchodilators, corticosteroids or their combinations delivered by inhaler devices
- COPD patients not adherent (TAI ≤ 45) to recommended therapy
- COPD patients with a CAT score ≥18.
- Must be capable of giving informed consent to participate, and available to comply with the requirements and procedures foreseen by the study protocol.
Who cannot join
- COPD patients with history of recent (< 4 weeks) upper respiratory tract infections and/or airways exacerbations
- patients with recent (< 2 months) pulmonary surgery or any active diseases that, in the judgement of the investigator, may interfere with the study protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Switching COPD Patients From Inhaler Devices to the Omron C28P Nebuliser: a Prospective, Real-world Study
The cornerstone of COPD therapy is based on the use of inhalation drugs. The correct use of devices is crucial; a suboptimal use technique is the cause of a possible clinical deterioration with a consequent increase in exacerbations and healthcare expenditure. Inhalation of drugs by nebulizer, in specific populations of patients who have shown poor adherence to inhalation therapy and poor symptomatological control, could be a more advantageous therapeutic strategy than pMDIs or DPIs, not requiring coordination at the time of delivery and not requiring an effective inspiratory effort.
The objective of this study is to evaluate the effects of the transition from portable inhalers (pMDIs or DPIs) to an innovative prototype Omron C28P nebulizer, measured primarily as changes in treatment adhesion and respiratory symptoms. The sudy design is open, single-arm, real-life, prospective study conducted in two tertiary level respiratory centers in Italy, with assessments conducted on the occasion of patients' visits to their doctor.
Read the detailed description
The cornerstone of pharmacological treatment of COPD is represented by bronchodilator and corticosteroid medications delivered by pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs). Any inhaler device category can be equally effective in treating patients if properly used. However, each device exhibits distinct properties that warrant consideration in achieving successful medication delivery. Errors frequently observed in patients with obstructive pulmonary diseases are incorrect coordination between inspiration and pMDIs activation and insufficient inspiratory effort or wrong device preparation with DPIs. Suboptimal inhaler technique is the prominent reason for the lack of efficacy and can contribute to poor adherence to medications that, in turn, is associated with worsening in disease control, increased rate of exacerbations, increased healthcare resource consumption, and consequently increased healthcare expenditure. Inhaler devices, which may seem simple to use to healthcare providers, frequently present challenges particularly for elderly patients with COPD. The combined effects of co-morbidities, the complexity of the accompanying medication regimens, as well as age- and disease-related lung function decline may add to the complexity of using different inhalers.
Once set up, nebulisers are easier for patients to use than pMDIs or DPIs as they only require tidal respiration for effective drug delivery with, therefore, no need to coordinate inspiration with device activation as for pMDIs, or to require high inspiratory effort as for DPIs. The primary aim of the present study is to assess the effect on inhaler adherence and disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P nebuliser, as assessed by means of the Test of Adherence to Inhalers (TAI) questionnaire and the COPD Assessment Test (CAT), respectively. The investigators plan to enroll 99 adult outpatients of both genders with a diagnosis of COPD of any functional severity; a sample size of 99 patients was chosen to design the study to have a 80% statistical power of detecting a difference of 2.07 (±1.03 SD) and of 3 (±5 SD) in TAI and CAT score, respectively, after device switching. The study consists of a baseline (T0) and 2 follow-up visits at 8 (T1) and 24 (T2) weeks (±2) after enrolment. On each study visit, after completion of clinical history and measurements of vital parameters, patients will be requested to rate their adherence to inhalers by filling the TAI questionnaire. Impact of COPD on health status and dyspnoea perception will be assessed by measuring the CAT score and the mMRC score. After completion of the above-mentioned procedures, patients will be carefully instructed by trained investigators on the use of the Omron C28P nebuliser. To this end, practical session with the nebuliser and dedicated videos will be used.
- Being tested
- Omron C28P nebuliser
- 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.
Omron C28P nebuliserDevice
switch from portable inhalers to the Omron C28P nebuliser
| Study group | Role | What they receive |
|---|---|---|
| Omron C28P cohort | Experimental | Patients diagnosed with COPD using the study device (OMRONC28P) for 24 weeks. Receives: Device: Omron C28P nebuliser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of the present study is to assess the effect on inhaler adherence to the Omron C28P
The primary aim of the present study is to assess the effect on inhaler adherence to the Omron C28P, assessed by means of the Test of Adherence to Inhalers (TAI) questionnaire
Measured: 24 weeks
The co-primary aim of the present study is to assess the effect on disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P
The co-primary aim of the present study is to assess the effect on disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P assessed by means of the COPD Assessment Test (CAT)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionApr 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 COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open, single-arm, real-life, prospective study
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Principal investigator, BONINI MATTEO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061679
- Sponsor's protocol ID
- 5432
- Acronym
- OMRON
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Switching COPD Patients From Inhaler Devices to the Omron C28P Nebuliser: a Prospective, Real-world Study
- ClinicalTrials.gov ID
- NCT06061679
- Acronym / sponsor ID
- OMRON / 5432
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 29 Sep 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.
The cornerstone of COPD therapy is based on the use of inhalation drugs. The correct use of devices is crucial; a suboptimal use technique is the cause of a possible clinical deterioration with a consequent increase in exacerbations and healthcare expenditure. Inhalation of drugs by nebulizer, in specific populations of patients who have shown poor adherence to inhalation therapy and poor symptomatological control, could be a more advantageous therapeutic strategy than pMDIs or DPIs, not requiring coordination at the time of delivery and not requiring an effective inspiratory effort.
The objective of this study is to evaluate the effects of the transition from portable inhalers (pMDIs or DPIs) to an innovative prototype Omron C28P nebulizer, measured primarily as changes in treatment adhesion and respiratory symptoms. The sudy design is open, single-arm, real-life, prospective study conducted in two tertiary level respiratory centers in Italy, with assessments conducted on the occasion of patients' visits to their doctor.
Detailed description
The cornerstone of pharmacological treatment of COPD is represented by bronchodilator and corticosteroid medications delivered by pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs). Any inhaler device category can be equally effective in treating patients if properly used. However, each device exhibits distinct properties that warrant consideration in achieving successful medication delivery. Errors frequently observed in patients with obstructive pulmonary diseases are incorrect coordination between inspiration and pMDIs activation and insufficient inspiratory effort or wrong device preparation with DPIs. Suboptimal inhaler technique is the prominent reason for the lack of efficacy and can contribute to poor adherence to medications that, in turn, is associated with worsening in disease control, increased rate of exacerbations, increased healthcare resource consumption, and consequently increased healthcare expenditure. Inhaler devices, which may seem simple to use to healthcare providers, frequently present challenges particularly for elderly patients with COPD. The combined effects of co-morbidities, the complexity of the accompanying medication regimens, as well as age- and disease-related lung function decline may add to the complexity of using different inhalers.
Once set up, nebulisers are easier for patients to use than pMDIs or DPIs as they only require tidal respiration for effective drug delivery with, therefore, no need to coordinate inspiration with device activation as for pMDIs, or to require high inspiratory effort as for DPIs. The primary aim of the present study is to assess the effect on inhaler adherence and disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P nebuliser, as assessed by means of the Test of Adherence to Inhalers (TAI) questionnaire and the COPD Assessment Test (CAT), respectively. The investigators plan to enroll 99 adult outpatients of both genders with a diagnosis of COPD of any functional severity; a sample size of 99 patients was chosen to design the study to have a 80% statistical power of detecting a difference of 2.07 (±1.03 SD) and of 3 (±5 SD) in TAI and CAT score, respectively, after device switching. The study consists of a baseline (T0) and 2 follow-up visits at 8 (T1) and 24 (T2) weeks (±2) after enrolment. On each study visit, after completion of clinical history and measurements of vital parameters, patients will be requested to rate their adherence to inhalers by filling the TAI questionnaire. Impact of COPD on health status and dyspnoea perception will be assessed by measuring the CAT score and the mMRC score. After completion of the above-mentioned procedures, patients will be carefully instructed by trained investigators on the use of the Omron C28P nebuliser. To this end, practical session with the nebuliser and dedicated videos will be used.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open, single-arm, real-life, prospective study
| Arm | Type | Receives |
|---|---|---|
| Omron C28P cohort | Experimental | Device: Omron C28P nebuliserPatients diagnosed with COPD using the study device (OMRONC28P) for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD patients treated by inhaled bronchodilators, corticosteroids or their combinations delivered by inhaler devices
- COPD patients not adherent (TAI ≤ 45) to recommended therapy
- COPD patients with a CAT score ≥18.
- Must be capable of giving informed consent to participate, and available to comply with the requirements and procedures foreseen by the study protocol.
Key exclusion criteria (2 listed)
- COPD patients with history of recent (< 4 weeks) upper respiratory tract infections and/or airways exacerbations
- patients with recent (< 2 months) pulmonary surgery or any active diseases that, in the judgement of the investigator, may interfere with the study protocol.
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 |
|---|---|---|
| Omron C28P nebuliserswitch from portable inhalers to the Omron C28P nebuliser | Device | Omron C28P cohort |
Primary outcome
The primary aim of the present study is to assess the effect on inhaler adherence to the Omron C28P
Time frame: 24 weeks
The primary aim of the present study is to assess the effect on inhaler adherence to the Omron C28P, assessed by means of the Test of Adherence to Inhalers (TAI) questionnaire
The co-primary aim of the present study is to assess the effect on disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P
Time frame: 24 weeks
The co-primary aim of the present study is to assess the effect on disease control of switching patients from their portable inhalers (either pMDIs or DPIs) to the Omron C28P assessed by means of the COPD Assessment Test (CAT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Omron C28P nebuliser in people with COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 2 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Matteo Bonini, Professor (0630157724, matteo.bonini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of the present study is to assess the effect on inhaler adherence to the Omron C28P (time frame: 24 weeks). 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 29 Sep 2023.