Factors Influencing on Correctness of Inhalation Technique.

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

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

Study Overview

• Status: Completed
• Conditions: Asthma; COPD
• Intervention / Treatment: Other: Assessment of correctness of inhaling technique

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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-097
    • Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with asthma or COPD; Adults (18-85 years old) with asthma or COPD diagnosed at least 3 months earlier, who are regularly treated with at least one inhlaer daily	Other: Assessment of correctness of inhaling technique; Assessment of correctness of inhaling technique in patients with asthma or COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Director: Rafał Krenke, MD,PhD,Prof, Warsaw Medical Univeristy

Publications and helpful links

General Publications

• 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 new inhalation therapies. Eur Respir J. 2011 Jun;37(6):1308-31. doi: 10.1183/09031936.00166410. Epub 2011 Feb 10.
• 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 reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2. Erratum In: Respir Med. 2012 May;106(5):757. DelDonno, Mario [corrected to Del Donno, Mario].
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: August 24, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: inhalation technique
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID Numbers: Inhalation technique 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No