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Comparison of 3 Methods to Assess Inhalation Technique

NCT04349735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-02-21

No results posted yet for this study

Summary

A significant percentage of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however none of them is recommended as the most accurate.

Therefore, the aim of the study is:

1. to compare three different methods of assessment of inhalation technique in patients with asthma and COPD.

These methods include:
1. Checklist of mistakes in inhalation technique (including critical mistakes)
2. 4 grade scale of inhalation technique
3. Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)
2. to analyze the influence of Vitalograph®AIM based inhalation technique training on inhalation skills

One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.

Conditions

Interventions

OTHER

Assessment of inhalation technique

Assessment of inhalation technique by 3 methods in every patient

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Rafał Krenke, MD,PhD,Prof · Medical University of Warsaw

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2022-10-01
Completion
2022-12-30

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04349735 on ClinicalTrials.gov