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Completed

NCT Number: NCT02131454

Efficacy of Inhalation Technique Training.

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.

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Key information

Conditions

Asthma Bronchial Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw

Warsaw, 02-097, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhalation technique training

Other

Training in inhalation technique in asthmatics and COPD patients

Primary outcomes

  1. Asthma or COPD exacerbations

    Time frame: 6 months

    The number and severity of asthma and COPD exacerbations.

Secondary outcomes

  1. 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

Other outcomes

  1. Disease control.

    Time frame: baseline , 3 months , 6 months

    Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 6, 2014
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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