Efficacy of Inhalation Technique Training.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).

Conditions
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Asthma, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Inhalation technique training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education and Inhalation technique training<br>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. | Other: Inhalation technique training<br>* Training in inhalation technique in asthmatics and COPD patients<br>|
| No Intervention: Education<br>Basic education about asthma and COPD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma or COPD exacerbations | The number and severity of asthma and COPD exacerbations. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life. | Change from baseline in quality of life questionnaires: for asthma patients - Asthma Quality of Life Questionnaire for COPD patients - Saint George's Respiratory Questionnaire | baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma and COPD treatment, inhalation techniques, training of inhalation