AsthmaChoice DeviceNCT05264441
Choice of Inhalation Device
A study testing In-Check DIAL G16 in people with Asthma and COPD, run by Universitair Ziekenhuis Brussel.
Trial summary
In this study, asthma and COPD patients will be invited to participate after the consultation with their pulmonologist. The intervention consists of three steps. The first step is to perform a deep inspiration. The second step is to demonstrate the correct use of a pMDI. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- In-Check DIAL G16
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Jun 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients (GOLD II-IV)
- Patients with severe asthma
- Patients with mild-to moderate asthma aged < 70y
- Patients with asthma aged ≥ 70y
Who cannot join
- Patients with asthma or COPD not on inhaled therapy for maintenance treatment
- Patients younger than 18y
- Patients unable to give their informed consent due to mental or physical disability
- Patients who don't speak French or Dutch
About this study
Official title: Choice of Inhalation Device in Asthma and COPD Patients
In this study, asthma and COPD patients will be invited to participate after the consultation with their pulmonologist.
The intervention consists of three steps. The first step is to perform a deep inspiration. The second step is to demonstrate the correct use of a pMDI. The third step is to perform a strong inspiration into the In-Check Dial device over 5 different resistances.
Read the detailed description
The study will take place in the respiratory outpatient clinic. Patients will be invited to participate in the study after the consultation with the pulmonologist. All pulmonologists have a flowchart regarding the optimal choice of inhaler at their disposition.
Patients will be provided sufficient time to read the informed consent file and to ask questions about the study. After giving their informed consent they will be screened for eligibility by an investigator. Demographic data and characteristics will be retrieved from the medical record (EMD) of study participants.
The intervention will consist of three different steps.
First, the patient will perform a deep voluntary inspiration. The patient's ability to perform this inspiration will be assessed and scored by the investigator.
Secondly, the peak inspiratory flows (PIF) will be measured with an In-check Dial device over 5 different resistances.
The minimal and optimal peak inspiratory flow rates (PIFRs) differ by device. A minimum flow of 30 L/min is required for most DPI's. The optimal flow varies from 30 L/min to 35, 45, 50, 60 or 65 L/min.
Due to the fact that there is still discussion about the effectiveness of PIF's going from 30 to 60 L/min, an arbitrary cut-off value will be set at 45 L/min. This cut-off value for sufficient PIF will be measured over a moderate resistance to distinguish subtherapeutic from therapeutic levels. If the patient reaches a PIF lower than 45 L/min, the patient will be asked to make a second attempt.
Subsequently, the patient will receive education about the correct coordination, which is necessary in the use of dose inhalers. The patient will be evaluated for sufficient actuation-inhalation coordination, through a placebo pMDI.
The evaluation of the voluntary deep inspiration, PIF and coordination will be by pass or fail evaluation. Subsequently, the fitness of a patient to use any of the three inhaler classes will be determined by using a diagram designed by a Belgian expert group (unpublished to date; courtesy of Didier Cataldo, ULiège).
If a mismatch between prescribed inhaler and suitable inhaler types is found, the treating physician of the patient will be informed. By doing so, the investigators wish to avoid patients receiving prescriptions for inhalers that they cannot use properly.
- Being tested
- In-Check DIAL G16
- Keywords
- Inhaler Device, In-Check DIAL G16
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Check DIAL G16Device
Patients will inspire into an In-Check DIAL G16 device.
| Study group | Role | What they receive |
|---|---|---|
| Asthma and COPD patients | Other | There will be only 1 arm in this study. COPD and asthma patients will be in the same arm. Receives: Device: In-Check DIAL G16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with device mismatch
Data from COPD and asthma patients will be compared
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross sectional
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264441
- Sponsor's protocol ID
- Choice Device
- Acronym
- Choice Device
- Status last verified
- Sep 2021
- First submitted
- 4 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Inhalation Device in Asthma and COPD Patients
- ClinicalTrials.gov ID
- NCT05264441
- Acronym / sponsor ID
- Choice Device / Choice Device
- Keywords
- Inhaler Device, In-Check DIAL G16
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 Mar 2022 (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.
In this study, asthma and COPD patients will be invited to participate after the consultation with their pulmonologist.
The intervention consists of three steps. The first step is to perform a deep inspiration. The second step is to demonstrate the correct use of a pMDI. The third step is to perform a strong inspiration into the In-Check Dial device over 5 different resistances.
Detailed description
The study will take place in the respiratory outpatient clinic. Patients will be invited to participate in the study after the consultation with the pulmonologist. All pulmonologists have a flowchart regarding the optimal choice of inhaler at their disposition.
Patients will be provided sufficient time to read the informed consent file and to ask questions about the study. After giving their informed consent they will be screened for eligibility by an investigator. Demographic data and characteristics will be retrieved from the medical record (EMD) of study participants.
The intervention will consist of three different steps.
First, the patient will perform a deep voluntary inspiration. The patient's ability to perform this inspiration will be assessed and scored by the investigator.
Secondly, the peak inspiratory flows (PIF) will be measured with an In-check Dial device over 5 different resistances.
The minimal and optimal peak inspiratory flow rates (PIFRs) differ by device. A minimum flow of 30 L/min is required for most DPI's. The optimal flow varies from 30 L/min to 35, 45, 50, 60 or 65 L/min.
Due to the fact that there is still discussion about the effectiveness of PIF's going from 30 to 60 L/min, an arbitrary cut-off value will be set at 45 L/min. This cut-off value for sufficient PIF will be measured over a moderate resistance to distinguish subtherapeutic from therapeutic levels. If the patient reaches a PIF lower than 45 L/min, the patient will be asked to make a second attempt.
Subsequently, the patient will receive education about the correct coordination, which is necessary in the use of dose inhalers. The patient will be evaluated for sufficient actuation-inhalation coordination, through a placebo pMDI.
The evaluation of the voluntary deep inspiration, PIF and coordination will be by pass or fail evaluation. Subsequently, the fitness of a patient to use any of the three inhaler classes will be determined by using a diagram designed by a Belgian expert group (unpublished to date; courtesy of Didier Cataldo, ULiège).
If a mismatch between prescribed inhaler and suitable inhaler types is found, the treating physician of the patient will be informed. By doing so, the investigators wish to avoid patients receiving prescriptions for inhalers that they cannot use properly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross sectional
| Arm | Type | Receives |
|---|---|---|
| Asthma and COPD patients | Other | Device: In-Check DIAL G16There will be only 1 arm in this study. COPD and asthma patients will be in the same arm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD patients (GOLD II-IV)
- Patients with severe asthma
- Patients with mild-to moderate asthma aged < 70y
- Patients with asthma aged ≥ 70y
Key exclusion criteria (4 listed)
- Patients with asthma or COPD not on inhaled therapy for maintenance treatment
- Patients younger than 18y
- Patients unable to give their informed consent due to mental or physical disability
- Patients who don't speak French or Dutch
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 |
|---|---|---|
| In-Check DIAL G16Patients will inspire into an In-Check DIAL G16 device. | Device | Asthma and COPD patients |
Primary outcome
Proportion of patients with device mismatch
Time frame: up to 2 months
Data from COPD and asthma patients will be compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing In-Check DIAL G16 in people with Asthma and COPD, run by Universitair Ziekenhuis Brussel.
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 4 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 3 Mar 2022. 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?
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?
Proportion of patients with device mismatch (time frame: up to 2 months). 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 3 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.