NCT05264441

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Apr 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 3, 2022

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

February 4, 2022

Last Update Submit

March 2, 2022

Conditions

AsthmaCOPD

Keywords

Inhaler DeviceIn-Check DIAL G16

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with device mismatch

    Data from COPD and asthma patients will be compared

    up to 2 months

Study Arms (1)

Asthma and COPD patients

OTHER

There will be only 1 arm in this study. COPD and asthma patients will be in the same arm.

Device: In-Check DIAL G16

Interventions

In-Check DIAL G16DEVICE

Patients will inspire into an In-Check DIAL G16 device.

Asthma and COPD patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients (GOLD II-IV)
  • Patients with severe asthma
  • Patients with mild-to moderate asthma aged \< 70y
  • Patients with asthma aged ≥ 70y

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cross sectional
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2022

First Posted

March 3, 2022

Study Start

April 1, 2022

Primary Completion

May 1, 2022

Study Completion

June 1, 2023

Last Updated

March 3, 2022

Record last verified: 2021-09