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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of correctness of inhaling technique | Other | Assessment of correctness of inhaling technique in patients with asthma or COPD |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of general demographic features | age (years) | baseline |
| Assessment of educational level | educational level (basic, secondary, higher) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for participating in the study
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| Name | Affiliation | Role |
|---|---|---|
| Rafał Krenke, MD,PhD,Prof | Warsaw Medical Univeristy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw | Warsaw | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21310878 | Result | 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. | |
| 21367593 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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 |
| 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. |
| 28288272 | 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. |
| 27060726 | 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. |
| 29338792 | 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |