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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
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Inhaler Device, In-Check DIAL G16

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 4, 2022
    Last Updated
    March 2, 2022
    Sponsor
    Universitair Ziekenhuis Brussel
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    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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