Factors Influencing on Correctness of Inhalation Technique.

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203446
• Other study ID #: Inhalation technique 1
• Status: Completed
• Start date: October 30, 2019
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 30, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Informed consent for participating in the study

2. Age 18 -85 years

3. COPD or asthma diagnosed at least 3 months prior to enrolment

4. using of at least one inhaler regularly every day

5. using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI)

Exclusion Criteria:

1. Lack of informed consent

2. Age <18 years or > 85 years old

3. Diagnosis of asthma or COPD shorter than 3 months before enrollment

4. Using inhalers unregularly.

5. Symptoms of infection 5 days prior to beginning of the study

Related Conditions & MeSH terms

• Asthma
• COPD
• Respiratory Aspiration

Intervention

Other:
• Assessment of correctness of inhaling technique
Assessment of correctness of inhaling technique in patients with asthma or COPD

Locations

Country	Name	City	State
Poland	Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Laube BL, Janssens HM, de Jongh FH, Devadason SG, Dhand R, Diot P, Everard ML, Horvath I, Navalesi P, Voshaar T, Chrystyn H; European Respiratory Society; International Society for Aerosols in Medicine. What the pulmonary specialist should know about the — View Citation

Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with redu — View Citation

Normansell R, Kew KM, Mathioudakis AG. Interventions to improve inhaler technique for people with asthma. Cochrane Database Syst Rev. 2017 Mar 13;3(3):CD012286. doi: 10.1002/14651858.CD012286.pub2. — View Citation

Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7. — View Citation

Usmani OS, Lavorini F, Marshall J, Dunlop WCN, Heron L, Farrington E, Dekhuijzen R. Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes. Respir Res. 2018 Jan 16;19(1):10. doi: 10.1186/s12931-017-0710-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of correctness of inhalation technique	Assessment of correctness of inhalation technique by list of inhalation errors and 4 point scale of proper inhaling and by two observers	baseline
Secondary	Assessment of general demographic features	age (years)	baseline
Secondary	Assessment of educational level	educational level (basic, secondary, higher)	baseline
Secondary	Assessment of general demographic features	smoking history (pack/years)	baseline
Secondary	Assessment of asthma or COPD duration	asthma or COPD duration	baseline
Secondary	Assessment of asthma or COPD severity	Asthma Control Test score or COPD Assessment Test score respectively for asthma and COPD	baseline
Secondary	Assessment of quality of life related to COPD	St. George's Questionnaire score for COPD	baseline
Secondary	Assessment of quality of life related to asthma	Asthma Quality of Life Questionnaire score for asthma	baseline
Secondary	Assessment of earlier training in inhalation technique	number of earlier trainings in inhalation technique	baseline
Secondary	Assessment of patient's adherence	number of days with missed doses of inhaled drugs per month	baseline
Secondary	Assesment of basic cognitive function	Mini-Mental State Examination score	baseline
Secondary	Assessment of vision impairments	assessment of vision impairments by Snellen vision test boards	baseline