Clinical trial NCT04203446: Factors Influencing on Correctness of Inhalation Technique.
Official title: Assessment of Clinical Factors Influencing on Correctness of Inhalation Technique in Adults With Asthma or COPD.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Keywords: inhalation technique
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of correctness of inhalation technique
timeFrame: baseline
Secondary outcomes:
measure: Assessment of general demographic features
timeFrame: baseline
measure: Assessment of educational level
timeFrame: baseline
measure: Assessment of general demographic features
timeFrame: baseline
measure: Assessment of asthma or COPD duration
timeFrame: baseline
measure: Assessment of asthma or COPD severity
timeFrame: baseline
measure: Assessment of quality of life related to COPD
timeFrame: baseline
measure: Assessment of quality of life related to asthma
timeFrame: baseline
measure: Assessment of earlier training in inhalation technique
timeFrame: baseline
measure: Assessment of patient's adherence
timeFrame: baseline
measure: Assesment of basic cognitive function
timeFrame: baseline
measure: Assessment of vision impairments
timeFrame: baseline
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Study officials:
affiliation: Warsaw Medical Univeristy
name: Rafał Krenke, MD,PhD,Prof
role: STUDY_DIRECTOR
References:
citation: 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.
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 reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.
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.
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.
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.