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Efficacy of Inhalation Technique Training.

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Inhalation technique training
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma and COPD treatment, inhalation techniques, training of inhalation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education and Inhalation technique training

Education

Arm Description

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.

Basic education about asthma and COPD.

Outcomes

Primary Outcome Measures

Asthma or COPD exacerbations
The number and severity of asthma and COPD exacerbations.

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2014
Last Updated
November 29, 2016
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02131454
Brief Title
Efficacy of Inhalation Technique Training.
Official Title
Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease
Keywords
asthma and COPD treatment, inhalation techniques, training of inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education and Inhalation technique training
Arm Type
Experimental
Arm Description
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.
Arm Title
Education
Arm Type
No Intervention
Arm Description
Basic education about asthma and COPD.
Intervention Type
Other
Intervention Name(s)
Inhalation technique training
Intervention Description
Training in inhalation technique in asthmatics and COPD patients
Primary Outcome Measure Information:
Title
Asthma or COPD exacerbations
Description
The number and severity of asthma and COPD exacerbations.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life.
Description
Change from baseline in quality of life questionnaires: for asthma patients - Asthma Quality of Life Questionnaire for COPD patients - Saint George's Respiratory Questionnaire
Time Frame
baseline, 3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Disease control.
Description
Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)
Time Frame
baseline , 3 months , 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21367593
Citation
Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2. Erratum In: Respir Med. 2012 May;106(5):757. DelDonno, Mario [corrected to Del Donno, Mario].
Results Reference
background
PubMed Identifier
22592354
Citation
Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.
Results Reference
background
PubMed Identifier
17629471
Citation
Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007 Nov;101(11):2395-401. doi: 10.1016/j.rmed.2007.06.008. Epub 2007 Jul 12.
Results Reference
background
PubMed Identifier
31213572
Citation
Dabrowska M, Luczak-Wozniak K, Miszczuk M, Domagala I, Lubanski W, Leszczynski A, Maskey-Warzechowska M, Rubinsztajn R, Hermanowicz-Salamon J, Krenke R. Impact of a Single Session of Inhalation Technique Training on Inhalation Skills and the Course of Asthma and COPD. Respir Care. 2019 Oct;64(10):1250-1260. doi: 10.4187/respcare.06740. Epub 2019 Jun 18.
Results Reference
derived

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Efficacy of Inhalation Technique Training.

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