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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
Sponsor:
Information provided by (Responsible Party):
Marta Dąbrowska, Medical University of Warsaw

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Other: Inhalation technique training Not Applicable

Detailed 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Asthma or COPD exacerbations [ Time Frame: 6 months ]
    The number and severity of asthma and COPD exacerbations.


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Disease control. [ Time Frame: baseline , 3 months , 6 months ]
    Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Poland
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Warsaw, Poland, 02-097
Sponsors and Collaborators
Medical University of Warsaw

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marta Dąbrowska, MD, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02131454     History of Changes
Other Study ID Numbers: WUM-TI
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016
Keywords provided by Marta Dąbrowska, Medical University of Warsaw:
asthma and COPD treatment
inhalation techniques
training of inhalation
Additional relevant MeSH terms:
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Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes