Efficacy of Inhalation Technique Training.
This trial is active, not recruiting.
|Conditions||asthma, chronic obstructive pulmonary disease|
|Treatment||inhalation technique training|
|Sponsor||Medical University of Warsaw|
|Start date||September 2013|
|End date||June 2016|
|Trial size||100 participants|
|Trial identifier||NCT02131454, WUM-TI|
Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the study is to determine if short training of inhalation technique in patients with obstructive diseases may influence the course of asthma and COPD.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Asthma or COPD exacerbations
time frame: 6 months
Quality of life.
time frame: baseline, 3 months, 6 months
Male or female participants from 18 years up to 80 years old.
Inclusion criteria: - age of 18 - 80 years - 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: - age less than 18 or above 80 years - 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
|Official title||Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).|
|Description||Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The inhalation technique is the key factor for effective management of bronchial obstruction. At the same time, a significant proportion of patients with asthma or COPD do not use inhalers properly. 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.|
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