Choice of Inhalation Device (Choice Device)
Primary Purpose
Asthma, COPD
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In-Check DIAL G16
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring Inhaler Device, In-Check DIAL G16
Eligibility Criteria
Inclusion Criteria:
- COPD patients (GOLD II-IV)
- Patients with severe asthma
- Patients with mild-to moderate asthma aged < 70y
- Patients with asthma aged ≥ 70y
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Asthma and COPD patients
Arm Description
There will be only 1 arm in this study. COPD and asthma patients will be in the same arm.
Outcomes
Primary Outcome Measures
Proportion of patients with device mismatch
Data from COPD and asthma patients will be compared
Secondary Outcome Measures
Full Information
NCT ID
NCT05264441
First Posted
February 4, 2022
Last Updated
March 2, 2022
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05264441
Brief Title
Choice of Inhalation Device
Acronym
Choice Device
Official Title
Choice of Inhalation Device in Asthma and COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
Keywords
Inhaler Device, In-Check DIAL G16
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cross sectional
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Asthma and COPD patients
Arm Type
Other
Arm Description
There will be only 1 arm in this study. COPD and asthma patients will be in the same arm.
Intervention Type
Device
Intervention Name(s)
In-Check DIAL G16
Intervention Description
Patients will inspire into an In-Check DIAL G16 device.
Primary Outcome Measure Information:
Title
Proportion of patients with device mismatch
Description
Data from COPD and asthma patients will be compared
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD patients (GOLD II-IV)
Patients with severe asthma
Patients with mild-to moderate asthma aged < 70y
Patients with asthma aged ≥ 70y
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Choice of Inhalation Device
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