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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

Tracking Information
First Submitted Date  ICMJE May 3, 2014
First Posted Date  ICMJE May 6, 2014
Last Update Posted Date November 30, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
Asthma or COPD exacerbations [ Time Frame: 6 months ]
The number and severity of asthma and COPD exacerbations.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02131454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2014)
Disease control. [ Time Frame: baseline , 3 months , 6 months ]
Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Inhalation Technique Training.
Official Title  ICMJE Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Other: Inhalation technique training
Training in inhalation technique in asthmatics and COPD patients
Study Arms  ICMJE
  • 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.
    Intervention: Other: Inhalation technique training
  • No Intervention: Education
    Basic education about asthma and COPD.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02131454
Other Study ID Numbers  ICMJE WUM-TI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marta Dąbrowska, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Warsaw
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP