Comparison of 3 Methods to Assess Inhalation Technique

NCT04349735 | Completed

• 1 other identifier: Inhalation technique 2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 1.to compare three different methods of assessment of inhalation technique in patients with asthma and COPD.
2. 2.Checklist of mistakes in inhalation technique (including critical mistakes)
3. 3.4 grade scale of inhalation technique
4. 4.Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)
5. 5.to analyze the influence of Vitalograph®AIM based inhalation technique training on inhalation skills

Conditions

Asthma; COPD

Keywords

inhalation technique

Outcome Measures

Primary Outcomes (5)

• Comparison of reliability of assessment of inhalation technique by checklist method in patients with asthma and COPD

  Assessment of reliability of checklist method measured by 2 observers by kappa Cohen coefficient

  baseline

• Comparison of reliability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD

  Assessment of reliability of 4 grade scale measured by 2 observers by kappa Cohen coefficient

  baseline

• Comparison of validity of assessment of inhalation technique by checklist method in patients with asthma and COPD

  Assessment of validity of checklist method measured by convergence between observer and an expert baseline by kappa Cohen coefficient

  baseline

• Comparison of validity of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD

  Assessment of validity of 4 grade scale measured by convergence between observer and an expert baseline by kappa Cohen coefficient

  baseline

• Comparison of validity of assessment of inhalation technique by Vitalograph®AIM in patients with asthma and COPD

  Assessment of validity of Vitalograph®AIM method (convergence between assessment of Vitalograph®AIM and an expert)

  30 minutes from baseline

Secondary Outcomes (3)

• Utility of Vitalograph® AIM in inhalation technique training

  baseline and in 30 minutes

• Comparison of repeatability of assessment of inhalation technique by checklist method in patients with asthma and COPD

  baseline and in 30 minutes

• Comparison of repeatability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD

  baseline and in 30 minutes

Study Arms (1)

Adults with asthma or COPD

EXPERIMENTAL

Assessment of inhalation technique by three methods in all patients

Other: Assessment of inhalation technique

Interventions

Assessment of inhalation technique OTHER

Assessment of inhalation technique by 3 methods in every patient

Adults with asthma or COPD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent for participating in the study
• age 18-85 years
• COPD or asthma diagnosed at least 3 months prior to enrollment
• 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)

You may not qualify if:

• lack of informed consent
• age \<18 years or \> 85 years
• diagnosis of asthma or COPD not earlier than 3 months before enrollment
• using inhalers irregularly.
• symptoms of infection 5 days prior to beginning of the study
• comorbidity that could prevent patient from using Vitalograph®AIM to teach patient proper inhalation technique (i.e. advanced cognitive disorders, mental diseases, crucial neurological, vision or hearing disorders).

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, 02-097, Poland

Location

Related Publications (4)

• 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.

  PMID: 29338792 BACKGROUND

• 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.

  PMID: 21310878 RESULT

• 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.

  PMID: 21367593 RESULT

• 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.

  PMID: 27060726 RESULT

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafał Krenke, MD,PhD,Prof

  Medical University of Warsaw

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: comparison of three methods of assessment of inhaltion technique

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: April 16, 2020
• Study Start: October 10, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 30, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)