Factors Influencing on Correctness of Inhalation Technique.
Condition: Asthma; COPD
MeSH terms: Asthma; Respiratory Aspiration
Study type: Observational

Summary: 
      Asthma and COPD are common chronic diseases of respiratory system. The correct use of
      inhalers is crucial in terms of efficacy of the treatment, however both asthma and COPD
      patients quite frequently misuse the inhalers. The objective of this study is to determine
      the factors influencing the number of inhalation errors committed by asthma and COPD patients
      when using the inhalers.

      In included patients the inhalation technique will be evaluated (by both list of inhalation
      errors and 4 point scale of proper inhaling) by two observers and the below information will
      be collected:

        -  general demographic information and education level

        -  information concerning time of diagnosis, the previous course of disease, smoking
           history, number of previous inhalation techniques training, the sources of information
           about the inhalation technique and adherence to therapy

        -  Asthma Control Test or COPD Assessment Test (respectively for asthma and COPD)

        -  assessment of quality of life (St. George's Questionnaire for COPD and Asthma Quality of
           Life Questionnaire for asthma)

        -  cognitive functions assessment using Mini-Mental State Examination

        -  the simplified assessment of vision impairments

        -  the results of spirometry
    

Detailed description: 
      Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases of
      respiratory system. Asthma affects about 5% of adults in Poland. The inhaling therapy is the
      cornerstone of asthma treatment, especially inhaled glucocorticosteroids (ICS). The correct
      use of inhalers is crucial for efficiency of the therapy and reduction of undesirable side
      effects of medications. COPD is also a common chronic respiratory disease that affects about
      10% of adults above 40 years old. The most important action to prevent and to treat COPD is
      to stop smoking. The main medications used by COPD patients are inhaled bronchodilators. Both
      asthma and COPD patients misuse the inhalers.

      The objective of this study is to determine the factors influencing the number of inhalation
      errors committed by asthma and COPD patients when using the inhalers.

      Patients:

      Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for
      participating in the study. Power analysis and sample size calculations indicated that a
      sample size of 215 subjects (with either asthma or COPD) would provide statistical power to
      detect even weak correlation (r=0.2) assuming error alpha = 0.05, beta = 0.20 and 10% drop
      out.

      Study design

      In included patients inhalation technique will be evaluated (by both list of inhalation
      errors and 4 point scale of proper inhaling) by two observers and the below information will
      be gathered:

        -  general demographic information and education level

        -  information concerning time of diagnosis, the previous course of disease, smoking
           history, number of previous inhalation techniques training, the sources of information
           about the inhalation technique and adherence to therapy

        -  Asthma Control Test and COPD Assessment Test respectively for asthma and COPD

        -  assessment of quality of life with the disease (St. George's Questionnaire for COPD and
           Asthma Quality of Life Questionnaire for asthma)

        -  cognitive functions assessment using Mini-Mental State Examination

        -  the simplified assessment of vision impairments

        -  the results of spirometry The main outcome will be correlation between inhalation
           technique and other above mentioned factors.

      Identification of factors influencing the inhaling errors in patients with asthma or COPD
      will enable to plan the actions to improve the efficiency of inhaler medications use. At the
      end of the study all patients will be taught how to use their inhalers properly.
    

Intervention name(s): Assessment of correctness of inhaling technique
Intervention type(s): Other
Intervention description(s): Assessment of correctness of inhaling technique in patients with asthma or COPD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for
        participating in the study
      
Keywords: inhalation technique