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Completed

NCT Number: NCT04203446

Factors Influencing on Correctness of Inhalation Technique.

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw

Warsaw, 02-097, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent for participating in the study
  • Age 18 -85 years
  • COPD or asthma diagnosed at least 3 months prior to enrolment
  • 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 old
  • Diagnosis of asthma or COPD shorter than 3 months before enrollment
  • Using inhalers unregularly.
  • Symptoms of infection 5 days prior to beginning of the study

Treatment and study plan

Assessment of correctness of inhaling technique

Other

Assessment of correctness of inhaling technique in patients with asthma or COPD

Primary outcomes

  1. Assessment of correctness of inhalation technique

    Time frame: baseline

    Assessment of correctness of inhalation technique by list of inhalation errors and 4 point scale of proper inhaling and by two observers

Secondary outcomes

  1. Assessment of general demographic features

    Time frame: baseline

    age (years)

  2. Assessment of educational level

    Time frame: baseline

    educational level (basic, secondary, higher)

  3. Assessment of general demographic features

    Time frame: baseline

    smoking history (pack/years)

  4. Assessment of asthma or COPD duration

    Time frame: baseline

    asthma or COPD duration

  5. Assessment of asthma or COPD severity

    Time frame: baseline

    Asthma Control Test score or COPD Assessment Test score respectively for asthma and COPD

  6. Assessment of quality of life related to COPD

    Time frame: baseline

    St. George's Questionnaire score for COPD

  7. Assessment of quality of life related to asthma

    Time frame: baseline

    Asthma Quality of Life Questionnaire score for asthma

  8. Assessment of earlier training in inhalation technique

    Time frame: baseline

    number of earlier trainings in inhalation technique

  9. Assessment of patient's adherence

    Time frame: baseline

    number of days with missed doses of inhaled drugs per month

  10. Assesment of basic cognitive function

    Time frame: baseline

    Mini-Mental State Examination score

  11. Assessment of vision impairments

    Time frame: baseline

    assessment of vision impairments by Snellen vision test boards

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Assessment of Clinical Factors Influencing on Correctness of Inhalation Technique in Adults With Asthma or COPD.

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Dec 18, 2019
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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