Comparison of 3 Methods to Assess Inhalation Technique
Condition: Asthma; COPD
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional

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.
    

Detailed description: 
      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..
    

Intervention name(s): Assessment of inhalation technique
Intervention type(s): Other
Intervention description(s): Assessment of inhalation technique by 3 methods in every patient
Intervention model: Single Group Assignment
Intervention model description: comparison of three methods of assessment of inhaltion technique
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inhalation technique