Comparison of 3 Methods to Assess Inhalation Technique

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Asthma and chronic obstructive pulmonary disease (COPD) are common respiratory diseases. Inhaled therapy is the cornerstone of treatment in these two diseases. However, a significant proportion 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, particularly before introducing changes to the patient's inhalation therapy. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however, none of these methods 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 an influence of using Vitalograph®AIM based inhalation technique training on inhalation skills.

Type of study: prospective, interventional, without randomization. Patients with asthma or COPD treated in hospital or in an out-patient clinic will be asked to participate in the study.

Study design 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. The reference assessment will be performed by two experienced pulmonologists.

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.

Outcomes

1. Comparison of three different methods of assessment of inhalation technique in patients with asthma and COPD (reliability, validity and accuracy)
2. Difference in the number of mistakes made during inhalation before and after the Vitalograph® AIM based training.

Investigators expect that results of this study will allow to identify the most accurate method for assessment of inhalation technique. Furthermore, the impact of Vitalograph®AIM based training on inhalation skills will be assessed..

Conditions

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Asthma COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

comparison of three methods of assessment of inhaltion technique

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adults with asthma or COPD

Assessment of inhalation technique by three methods in all patients

Group Type EXPERIMENTAL

Assessment of inhalation technique

Intervention Type OTHER

Assessment of inhalation technique by 3 methods in every patient

Interventions

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Assessment of inhalation technique

Assessment of inhalation technique by 3 methods in every patient

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* informed consent for participating in the study
* age 18-85 years
* COPD or asthma diagnosed at least 3 months prior to enrollment
* using of at least one inhaler regularly every day
* using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI)

Exclusion Criteria

* lack of informed consent
* age \<18 years or \> 85 years
* diagnosis of asthma or COPD not earlier than 3 months before enrollment
* using inhalers irregularly.
* symptoms of infection 5 days prior to beginning of the study
* comorbidity that could prevent patient from using Vitalograph®AIM to teach patient proper inhalation technique (i.e. advanced cognitive disorders, mental diseases, crucial neurological, vision or hearing disorders).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No