Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-09-30
2016-08-31
Brief Summary
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Detailed Description
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The aim of the study is:
* to analyze the frequency and type of common mistakes in inhalation technique and
* to determine the impact of short individual training of inhalation technique on the course of asthma and COPD.
Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the study.
The stage of severity (COPD) and control of the disease (asthma), quality of life, proper inhaler intake will be assessed at the study onset and at a second visit after 6 months.
At the second visit all patients will get a short, individual information about the etiology, course and general treatment plan of asthma / COPD. Patients will be randomized into two groups:
A. group of patients trained in proper inhalation technique B. group of patients without inhalation technique training Control visits will be held 3 and 6 months after training.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Education and Inhalation technique training
Training in technique of drug inhalation in asthma and COPD patients and education about the role of inhalation therapy in the course of the disease.
Inhalation technique training
Training in inhalation technique in asthmatics and COPD patients
Education
Basic education about asthma and COPD.
No interventions assigned to this group
Interventions
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Inhalation technique training
Training in inhalation technique in asthmatics and COPD patients
Eligibility Criteria
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Inclusion Criteria
* asthma or COPD diagnosed at least 6 months before study enrollment
* everyday usage of at least one of the following: pressured meter dose inhaler (pMDI) or dry powdered inhaler (Aerolizer, Handihaler, Disc or Turbuhaler)
* no other comorbidities that could influence learning of inhalation technique (psychiatric or neurologic disorders)
Exclusion Criteria
* lack of informed consent
* asthma or COPD diagnosed less than 6 months prior to screening visit
* coexistence of respiratory diseases other than asthma or COPD
* irregular use (not every day) of at least one inhaled drug
* treatment with inhalers other than: pMDI, Disc, Turbuhaler, Handihaler or Aerolizer
18 Years
80 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Marta Dąbrowska
MD, PhD
Locations
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Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Warsaw, , Poland
Countries
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References
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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.
Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.
Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007 Nov;101(11):2395-401. doi: 10.1016/j.rmed.2007.06.008. Epub 2007 Jul 12.
Dabrowska M, Luczak-Wozniak K, Miszczuk M, Domagala I, Lubanski W, Leszczynski A, Maskey-Warzechowska M, Rubinsztajn R, Hermanowicz-Salamon J, Krenke R. Impact of a Single Session of Inhalation Technique Training on Inhalation Skills and the Course of Asthma and COPD. Respir Care. 2019 Oct;64(10):1250-1260. doi: 10.4187/respcare.06740. Epub 2019 Jun 18.
Other Identifiers
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WUM-TI
Identifier Type: -
Identifier Source: org_study_id