Efficacy of Inhalation Technique Training.
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|ClinicalTrials.gov Identifier: NCT02131454|
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : November 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asthma Chronic Obstructive Pulmonary Disease||Other: Inhalation technique training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||August 2016|
Experimental: 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.
Other: Inhalation technique training
Training in inhalation technique in asthmatics and COPD patients
No Intervention: Education
Basic education about asthma and COPD.
- Asthma or COPD exacerbations [ Time Frame: 6 months ]The number and severity of asthma and COPD exacerbations.
- Quality of life. [ Time Frame: baseline, 3 months, 6 months ]
Change from baseline in quality of life questionnaires:
for asthma patients - Asthma Quality of Life Questionnaire for COPD patients - Saint George's Respiratory Questionnaire
- Disease control. [ Time Frame: baseline , 3 months , 6 months ]Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131454
|Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw|
|Warsaw, Poland, 02-097|