Factors Influencing on Correctness of Inhalation Technique.

NCT04203446 | Completed

• 1 other identifier: Inhalation technique 1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Asthma; COPD

Keywords

inhalation technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Assessment of general demographic features

  baseline

• Assessment of educational level

  baseline

• Assessment of general demographic features

  baseline

• Assessment of asthma or COPD duration

  baseline

• Assessment of asthma or COPD severity

  baseline

Study Arms (1)

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

Interventions

Assessment of correctness of inhaling technique OTHER

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

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+)
• 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

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 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)

You may not qualify if:

• 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

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 (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 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

• 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.

  PMID: 28288272 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

• 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 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

  Warsaw Medical Univeristy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: December 18, 2019
• Study Start: October 30, 2019
• Primary Completion: December 15, 2022
• Study Completion: January 30, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

PL (1)