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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
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
(No Intervention)
Basic education about asthma and COPD.

Primary Outcomes

Asthma or COPD exacerbations
time frame: 6 months

Secondary Outcomes

Quality of life.
time frame: baseline, 3 months, 6 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Medical University of Warsaw.